Ambien Zolpidem withdrawal. Ambien
Zolpidem withdrawal step by step procedures.
Ambien Zolpidem
Withdrawal
Ambien withdrawal can be a thing of the
past. Most likely you are having Ambien withdrawal before
finding this website. Getting you stable again is the first
thing to do.
Go back up to the last dosage of Ambien
you were doing ok at, where you felt stable, and remain at
that Ambien dosage until you get the supplements in you will
need.
At this point it's likely more than
insomnia you are experiencing. The daytime hours are
probably pretty rough as well. A brain on fire is how many
describe Ambien withdrawal.
You will need to get 3 supplements: JNK
Formula Complete, Neuro Day and Neuro Night. Just follow the
How to Take instructions on each bottle, with a little
exception. The Neuro Night is formulated to help with sleep
and you do not want to take the Neuro Night while still
taking the Ambien.
The night you no longer take Ambien,
begin taking 2 capsules of Neuro Night 15-minutes before
bedtime.
With you taking the JNK Formula and and
Neuro Day you should be stress and anxiety free during the
daytime and more relaxed when bedtime comes.
To order the supplements
Click here
FULL
PRESCRIBING INFORMATION
INDICATIONS
AND USAGE
Ambien CR (zolpidem tartrate
extended-release tablets) is indicated for the treatment of
insomnia characterized by difficulties with sleep onset
and/or sleep maintenance (as measured by wake time after
sleep onset).The clinical trials performed in support of
efficacy were up to 3 weeks (using polysomnography
measurement up to 2 weeks in both adult and elderly
patients) and 24 weeks (using patient-reported assessment in
adult patients only) in duration
DOSAGE AND
ADMINISTRATION
The dose of
Ambien CR should be individualized. Dosage in adults The
recommended dose of Ambien CR for adults is 12.5 mg once
daily immediately before bedtime. The total Ambien CR dose
should not exceed 12.5 mg per day.
Special
populations Elderly or debilitated patients may be
especially sensitive to the effects of zolpidem tartrate.
Patients with hepatic insufficiency do not clear the drug as
rapidly as normal. The recommended dose of Ambien CR in both
of these patient populations is 6.25 mg once daily
immediately before bedtime Use with CNS depressants
Dosage
adjustments may be necessary when Ambien CR is combined with
other CNS depressant drugs because of the potentially
additive effects Administration Ambien CR extended-release
tablets should be swallowed whole, and not be divided,
crushed, or chewed. The effect of Ambien CR may be slowed by
ingestion with or immediately after a meal.
DOSAGE FORMS
AND STRENGTHS
Ambien CR is
available as extended-release tablets containing 6.25 mg or
12.5 mg of zolpidem tartrate for oral administration.
Tablets are not scored. Ambien CR 6.25 mg tablets are pink,
round, bi-convex, and debossed with A~ on one side. Ambien
CR 12.5 mg tablets are blue, round, bi-convex, and debossed
with A~ on one side.
CONTRAINDICATIONS
Ambien CR is contraindicated in
patients with known hypersensitivity to zolpidem tartrate or
to any of the inactive ingredients in the formulation.
Observed reactions include anaphylaxis and angioedema
WARNINGS AND
PRECAUTIONS
Need to
evaluate for co-morbid diagnoses because sleep disturbances
may be the presenting manifestation of a physical and/or
psychiatric disorder, symptomatic treatment of insomnia
should be initiated only after a careful evaluation of the
patient. The failure of insomnia to remit after 7 to 10 days
of treatment may indicate the presence of a primary
psychiatric and/or medical illness that should be evaluated.
Worsening of insomnia or the emergence of new thinking or
behavior abnormalities may be the consequence of an
unrecognized psychiatric or physical disorder. Such findings
have emerged during the course of treatment with
sedative/hypnotic drugs, including zolpidem. Severe
anaphylactic and anaphylactoid reactions
Rare cases of
angioedema involving the tongue, glottis or larynx have been
reported in patients after taking the first or subsequent
doses of sedative-hypnotics, including zolpidem. Some
patients have had additional symptoms such as dyspnea,
throat closing or nausea and vomiting that suggest
anaphylaxis. Some patients have required medical therapy in
the emergency department. If angioedema involves the throat,
glottis or larynx, airway obstruction may occur and be
fatal. Patients who develop angioedema after treatment with
zolpidem should not be rechallenged with the drug.
Abnormal
thinking and behavioral changes. A variety of abnormal
thinking and behavior changes have been reported to occur in
association with the use of sedative/hypnotics. Some of
these changes may be characterized by decreased inhibition
(e.g. aggressiveness and extroversion that seemed out of
character), similar to effects produced by alcohol and other
CNS depressants. Visual and auditory hallucinations have
been reported as well as behavioral changes such as bizarre
behavior, agitation and depersonalization. In controlled
trials, <1% of adults with insomnia who received zolpidem
reported hallucinations. In a clinical trial, 7.4% of
pediatric patients with insomnia associated with
attention-deficit/hyperactivity disorder (ADHD), who
received zolpidem reported hallucinations [Complex behaviors
such as "sleep-driving" (i.e., driving while not fully awake
after ingestion of a sedative-hypnotic, with amnesia for the
event) have been reported with sedative-hypnotics, including
zolpidem. These events can occur in sedative-hypnotic-naive
as well as in sedative-hypnotic-experienced persons.
Although behaviors such as "sleep-driving" may occur with
Ambien CR alone at therapeutic doses, the use of alcohol and
other CNS depressants with Ambien CR appears to increase the
risk of such behaviors, as does the use of Ambien CR at
doses exceeding the maximum recommended dose. Due to the
risk to the patient and the community, discontinuation of
Ambien CR should be strongly considered for patients who
report a "sleep-driving" episode. Other complex behaviors
(e.g., preparing and eating food, making phone calls, or
having sex) have been reported in patients who are not fully
awake after taking a sedative-hypnotic. As with
"sleep-driving", patients usually do not remember these
events. Amnesia, anxiety and other neuro-psychiatric
symptoms may occur unpredictably.
In primarily
depressed patients, worsening of depression, including
suicidal thoughts and actions (including completed
suicides), have been reported in association with the use of
sedative/hypnotics. It can rarely be determined with
certainty whether a particular instance of the abnormal
behaviors listed above is drug induced, spontaneous in
origin, or a result of an underlying psychiatric or physical
disorder. Nonetheless, the emergence of any new behavioral
sign or symptom of concern requires careful and immediate
evaluation.
Withdrawal
effects
Following the rapid dose decrease or
abrupt discontinuation of sedative/hypnotics, there have
been reports of signs and symptoms similar to those
associated with withdrawal from other CNS-depressant drugs
[CNS depressant effects Ambien CR, like other
sedative/hypnotic drugs, has CNS-depressant effects.
Due to the
rapid onset of action, Ambien CR should only be taken
immediately prior to going to bed. Patients should be cautioned against
engaging in hazardous occupations requiring complete mental
alertness or motor coordination such as operating machinery
or driving a motor vehicle after ingesting the drug,
including potential impairment of the performance of such
activities that may occur the day following ingestion of
Ambien CR. Ambien CR showed additive effects when combined
with alcohol and should not be taken with alcohol. Patients
should also be cautioned about possible combined effects
with other CNS-depressant drugs. Dosage adjustments may be
necessary when Ambien CR is administered with such agents
because of the potentially additive effects.
Special
populations
Use in the elderly and/or debilitated
patients: Impaired motor and/or cognitive performance after
repeated exposure or unusual sensitivity to
sedative/hypnotic drugs is a concern in the treatment of
elderly and/or debilitated patients. Therefore, the
recommended Ambien CR dosage is 6.25 mg in such patients to
decrease the possibility of side effects. These patients
should be closely monitored. Use in patients with
concomitant illness: Clinical experience with Ambien CR
(zolpidem tartrate) in patients with concomitant systemic
illness is limited. Caution is advisable in using Ambien CR
in patients with diseases or conditions that could affect
metabolism or hemodynamic responses.
Although
studies did not reveal respiratory depressant effects at
hypnotic doses of zolpidem in normal or in patients with
mild to moderate chronic obstructive pulmonary disease
(COPD), a reduction in the Total Arousal Index together with
a reduction in lowest oxygen saturation and increase in the
times of oxygen desaturation below 80% and 90% was observed
in patients with mild-to-moderate sleep apnea when treated
with an immediate-release formulation of zolpidem tartrate
(10 mg) when compared to placebo. Since sedative/hypnotics
have the capacity to depress respiratory drive, precautions
should be taken if Ambien CR is prescribed to patients with
compromised respiratory function. Post-marketing reports of
respiratory insufficiency, most of which involved patients
with pre-existing respiratory impairment, have been
received. Ambien CR should be used with caution in patients
with sleep apnea syndrome or myasthenia gravis.
Data in
end-stage renal failure patients repeatedly treated with an
immediate-release formulation of zolpidem tartrate (10 mg)
did not demonstrate drug accumulation or alterations in
pharmacokinetic parameters. No dosage adjustment in renally
impaired patients is required; however, these patients
should be closely monitored A study in subjects with hepatic
impairment did reveal prolonged elimination in this group;
therefore, treatment should be initiated with Ambien CR 6.25
mg in patients with hepatic compromise, and they should be
closely monitored Use in patients with depression: As with
other sedative/hypnotic drugs, Ambien CR should be
administered with caution to patients exhibiting signs or
symptoms of depression. Suicidal tendencies may be present
in such patients and protective measures may be required.
Intentional overdosage is more common in this group of
patients; therefore, the least amount of drug that is
feasible should be prescribed for the patient at any one
time.
Use in
pediatric patients: Safety and effectiveness of zolpidem has
not been established in pediatric patients. In an 8-week
study in pediatric patients (aged 6–17 years) with insomnia
associated with ADHD given an immediate-release oral
solution of zolpidem tartrate, zolpidem did not decrease
sleep latency compared to placebo. Hallucinations were
reported in 7.4% of the pediatric patients who received
zolpidem; none of the pediatric patients who received
placebo reported hallucinations
ADVERSE
REACTIONS
The following serious adverse reactions
are discussed in greater detail in other sections of the
labeling:¥Serious anaphylactic and anaphylactoid reactions
¥Abnormal thinking, behavior changes, and complex behaviors
Withdrawal effects CNS-depressant effects
Clinical
trials experience
Associated with
discontinuation of treatment: In 3-week clinical trials in
adults and elderly patients (> 65 years), 3.5% (7/201)
patients receiving Ambien CR 6.25 or 12.5 mg discontinued
treatment due to an adverse reaction as compared to 0.9%
(2/216) of patients on placebo. The reaction most commonly
associated with discontinuation in patients treated with
Ambien CR was somnolence (1%).In a 6-month study in adult
patients (18–64 years of age), 8.5% (57/669) of patients
receiving Ambien CR 12.5 mg as compared to 4.6% on placebo
(16/349) discontinued treatment due to an adverse reaction.
Reactions most commonly associated with discontinuation of
Ambien CR included anxiety (anxiety, restlessness or
agitation) reported in 1.5% (10/669) of patients as compared
to 0.3% (1/349) of patients on placebo, and depression
(depression, major depression or depressed mood) reported in
1.5% (10/669) of patients as compared to 0.3% (1/349) of
patients on placebo.
Data from a
clinical study in which selective serotonin reuptake
inhibitor- (SSRI-) treated patients were given zolpidem
revealed that four of the seven discontinuations during
double-blind treatment with zolpidem (n=95) were associated
with impaired concentration, continuing or aggravated
depression, and manic reaction; one patient treated with
placebo (n =97) was discontinued after an attempted suicide.
Most commonly
observed adverse reactions in controlled trials: During
treatment with Ambien CR in adults and elderly at daily
doses of 12.5 mg and 6.25 mg, respectively, each for three
weeks, the most commonly observed adverse reactions
associated with the use of Ambien CR were headache, next-day
somnolence, and dizziness.
In the 6-month
trial evaluating Ambien CR 12.5 mg, the adverse reaction
profile was consistent with that reported in short-term
trials, except for a higher incidence of anxiety (6.3% for
Ambien CR versus 2.6% for placebo).Adverse reactions
observed at an incidence of ≥1% in controlled trials: The
following tables enumerate treatment-emergent adverse
reaction frequencies that were observed at an incidence
equal to 1% or greater among patients with insomnia who
received Ambien CR in placebo-controlled trials. Events
reported by investigators were classified utilizing the
MedDRA dictionary for the purpose of establishing event
frequencies.
The prescriber
should be aware that these figures cannot be used to predict
the incidence of side effects in the course of usual medical
practice, in which patient characteristics and other factors
differ from those that prevailed in these clinical trials.
Similarly, the cited frequencies cannot be compared with
figures obtained from other clinical investigators involving
related drug products and uses, since each group of drug
trials is conducted under a different set of conditions.
However, the cited figures provide the physician with a
basis for estimating the relative contribution of drug and
nondrug factors to the incidence of side effects in the
population studied.
The following
tables were derived from results of two placebo-controlled
efficacy trials involving Ambien CR. These trials involved
patients with primary insomnia who were treated for 3 weeks
with Ambien CR at doses of 12.5 mg (Table 1) or 6.25 mg (Table
2),
respectively. The tables include only adverse reactions
occurring at an incidence of at least 1% for Ambien CR
patients and with an incidence greater than that seen in the
placebo patients.Table 1. Incidences of Treatment-Emergent
Adverse Reactions in a 3-Week Placebo-Controlled Clinical
Trial in Adults (percentage of patients reporting)Body
System/Adverse Reaction
*Ambien CR12.5
mgPlacebo(N = 102)(N = 110)Infections and
infestationsInfluenza30Gastroenteritis10Labyrinthitis10Metabolism
and nutrition disorders
Appetite
disorder10Psychiatric disorders Hallucinations
†40Disorientation32Anxiety20Depression20Psychomotor
retardation20Binge
eating10Depersonalization10Disinhibition10Euphoric
mood10Mood swings10Stress symptoms10Nervous system
disordersHeadache1916Somnolence152Dizziness125Memory
disorders
‡30Balance disorder20Disturbance in
attention20Hypoesthesia21Ataxia10Paresthesia10Eye
disorders Visual disturbance30Eye redness20Vision
blurred21Altered visual depth perception10Asthenopia10Ear
and labyrinth disordersVertigo20Tinnitus10Respiratory,
thoracic and mediastinal disorders Throat
irritation10Gastrointestinal
disordersNausea74Constipation20Abdominal
discomfort10Abdominal tenderness10Frequent bowel
movements10Gastroesophageal refluxdisease10Vomiting10Skin
and subcutaneous tissue disordersRash10Skin
wrinkling10Urticaria10Musculoskeletal and connective tissue
disorders Back pain43Myalgia40Neck pain10Reproductive system
and breast disordersMenorrhagia10General disorders and
administration site conditionsFatigue32Asthenia10Chest
discomfort10InvestigationsBlood pressure increased10Body
temperature increased10Injury, poisoning and procedural
complicationsContusion10Social circumstances Exposure to
poisonous plant10*Reactions reported by at least 1% of patients treated with Ambien
CR and at greater frequency than in the placebo group.†Hallucinations included hallucinations NOS as well as visual and
hypnogogic hallucinations. Memory disorders include: memory
impairment, amnesia, anterograde amnesia. Table 2. Incidences
of Treatment-Emergent Adverse Reactions in a 3-Week
Placebo-Controlled Clinical Trial in Elderly (percentage of
patients reporting)Body System/Adverse Reaction
*Ambien CRPlacebo6.25 mg(N=99)(N=106)Infections and
infestationsNasopharyngitis64Lower respiratory tract
infection10Otitis externa10Upper respiratory tract
infection10Psychiatric disordersAnxiety32Psychomotor
retardation20Apathy10Depressed mood10Nervous system
disordersHeadache1411Dizziness83Somnolence65Burning
sensation10Dizziness postural10Memory disorders
†10Muscle contractions
involuntary10Paresthesia10Tremor10Cardiac
disordersPalpitations20Respiratory, thoracic and mediastinal
disorders Dry throat10Gastrointestinal
disordersFlatulence10Vomiting10Skin and subcutaneous tissue
disordersRash10Urticaria10Musculoskeletal and connective
tissue disordersArthralgia20Muscle cramp21Neck pain20Renal
and urinary disordersDysuria10Reproductive system and breast
disorders Vulvo vaginal dryness10General disorders and
administration site conditions Influenza like
illness10Pyrexia10Injury, poisoning and procedural
complications Neck injury10*Reactions reported by at least 1% of patients treated with Ambien
CR and at greater frequency than in the placebo group. Memory disorders include: memory impairment, amnesia, anterograde
amnesia. Dose relationship for adverse reactions: There is
evidence from dose comparison trials suggesting a dose
relationship for many of the adverse reactions associated
with zolpidem use, particularly for certain CNS and
gastrointestinal adverse events.
DRUG
INTERACTIONSCNS-active drugs since the systematic
evaluations of zolpidem in combination with other CNS-active
drugs have been limited, careful consideration should be
given to the pharmacology of any CNS-active drug to be used
with zolpidem. Any drug with CNS-depressant effects could
potentially enhance the CNS-depressant effects of
zolpidem. An immediate-release formulation of zolpidem
tartrate was evaluated in healthy subjects in single-dose
interaction studies for several CNS drugs. Imipramine in
combination with zolpidem produced no pharmacokinetic
interaction other than a 20% decrease in peak levels of
imipramine, but there was an additive effect of decreased
alertness. Similarly, chlorpromazine in combination with
zolpidem produced no pharmacokinetic interaction, but there
was an additive effect of decreased alertness and
psychomotor performance. A study involving haloperidol and
zolpidem revealed no effect of haloperidol on the
pharmacokinetics or pharmacodynamics of zolpidem. The lack
of a drug interaction following single-dose administration
does not predict a lack following chronic administration.
An additive
effect on psychomotor performance between alcohol and
zolpidem was demonstrated A single-dose interaction study
with zolpidem 10 mg and fluoxetine 20 mg at steady-state
levels in male volunteers did not demonstrate any clinically
significant pharmacokinetic or pharmacodynamic interactions.
When multiple doses of zolpidem and fluoxetine at
steady-state concentrations were evaluated in healthy
females, the only significant change was a 17% increase in
the zolpidem half-life. There was no evidence of an additive
effect in psychomotor performance.
Following five
consecutive nightly doses of zolpidem 10 mg in the presence
of sertraline 50 mg (17 consecutive daily doses, at 7:00 am,
in healthy female volunteers), zolpidem Cmax was
significantly higher (43%) and Tmax was significantly
decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline
were unaffected by zolpidem.
Drugs that
affect drug metabolism via cytochrome P450Some compounds
known to inhibit CYP3A may increase exposure to zolpidem.
The effect of inhibitors of other P450 enzymes has not been
carefully evaluated.
A randomized,
double-blind, crossover interaction study in ten healthy
volunteers between itraconazole (200 mg once daily for 4
days) and a single dose of zolpidem (10 mg) given 5 hours
after the last dose of itraconazole resulted in a 34%
increase in AUC0–∞ of zolpidem. There were no significant
pharmacodynamic effects of zolpidem on subjective
drowsiness, postural sway, or psychomotor performance. A
randomized, placebo-controlled, crossover interaction study
in eight healthy female subjects between five consecutive
daily doses of rifampin (600 mg) and a single dose of an
immediate-release formulation of zolpidem tartrate (20 mg)
given 17 hours after the last dose of rifampin showed
significant reductions of the AUC (–73%), Cmax (–58%), and
T1/2 (–36%) of zolpidem together with significant reductions
in the pharmacodynamic effects of zolpidem.
A randomized
double-blind crossover interaction study in twelve healthy
subjects showed that co-administration of a single 5 mg dose
of immediate-release zolpidem tartrate with ketoconazole, a
potent CYP3A4 inhibitor, given as 200 mg twice daily for 2
days increased Cmax of zolpidem by a factor of 1.3 and
increased the total AUC of zolpidem by a factor of 1.7
compared to zolpidem alone and prolonged the elimination
half-life by approximately 30% along with an increase in the
pharmacodynamic effects of zolpidem. Caution should be used
when ketoconazole is given with zolpidem and consideration
should be given to using a lower dose of zolpidem when
ketoconazole and zolpidem are given together. Patients
should be advised that use of Ambien CR with ketoconazole
may enhance the sedative effects.
Other drugs
with no interaction with zolpidem A
study involving cimetidine/zolpidem and ranitidine/zolpidem
combinations revealed no effect of either drug on the
pharmacokinetics or pharmacodynamics of zolpidem. Zolpidem
had no effect on digoxin pharmacokinetics and did not affect
prothrombin time when given with warfarin in normal
subjects.
Drug-laboratory test interactions
Zolpidem is not
known to interfere with commonly employed clinical
laboratory tests. In addition, clinical data indicate that
zolpidem does not cross-react with benzodiazepines, opiates,
barbiturates, cocaine, cannabinoids, or amphetamines in two
standard urine drug screens.
USE IN
SPECIFIC POPULATIONS
Pregnancy
Category There are no adequate and well-controlled studies
of Ambien CR in pregnant women. Ambien CR should be used
during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Administration
of zolpidem to pregnant rats and rabbits resulted in adverse
effects on offspring development at doses greater than the
Ambien CR maximum recommended human dose (MRHD) of 12.5
mg/day (approximately 10 mg/day zolpidem base); however,
teratogenicity was not observed.
When zolpidem
was administered at oral doses of 4, 20, and 100 mg base/kg
(approximately 4, 20 and 100 times the MRHD on a mg/m2
basis) to pregnant rats during the period of organogenesis,
dose-related decreases in fetal skull ossification occurred
at all but the lowest dose, which is approximately 4 times
the MRHD on a mg/m2 basis. In rabbits treated during
organogenesis with zolpidem at oral doses of 1, 4, and 16 mg
base/kg (approximately 2, 8 and 30 times the MRHD on a mg/m2
basis), increased embryo-fetal death and incomplete fetal
skeletal ossification occurred at the highest dose. The
no-effect dose for embryo-fetal toxicity in rabbits is
approximately 8 times the MRHD on a mg/m2 basis.
Administration of zolpidem to rats at oral doses of 4, 20,
and 100 mg base/kg (approximately 4, 20 and 100 times the
MRHD on a mg/m2 basis) during the latter part of pregnancy
and throughout lactation produced decreased offspring growth
and survival at all but the lowest dose, which is
approximately 4 times the MRHD on a mg/m2 basis.
Neonatal
complications studies in children to assess the effects of
prenatal exposure to zolpidem have not been conducted;
however, cases of severe neonatal respiratory depression
have been reported when zolpidem was used at the end of
pregnancy, especially when taken with other CNS depressants.
Children born
to mothers taking sedative-hypnotic drugs may be at some
risk for withdrawal symptoms during the postnatal period.
Neonatal flaccidity has been reported in infants born to
mothers who received sedative-hypnotic drugs during
pregnancy.
Labor and
delivery Ambien CR has no established use in labor and
delivery nursing mothers Zolpidem is excreted in human milk.
Studies in lactating mothers indicate that the half-life of
zolpidem is similar to that in non-lactating women (2.6 ±
0.3 hr). The effect of zolpidem on the nursing infant is not
known. Caution should be exercised when Ambien CR is
administered to a nursing woman.
Pediatric use
Safety and effectiveness of zolpidem have not been
established in pediatric patients. In an 8-week controlled
study, 201 pediatric patients (aged 6–17 years) with
insomnia associated with attention-deficit/hyperactivity
disorder (90% of the patients were using psychoanaleptics),
were treated with an oral solution of zolpidem (n=136), or
placebo (n = 65). Zolpidem did not significantly decrease
latency to persistent sleep, compared to placebo, as
measured by polysomnography after 4 weeks of treatment.
Psychiatric and nervous system disorders comprised the most
frequent (> 5%) treatment emergent adverse reactions
observed with zolpidem versus placebo and included dizziness
(23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and
hallucinations (7.4% vs. 0%). Ten patients on zolpidem
(7.4%) discontinued treatment due to an adverse reaction.
FDA has not
required pediatric studies of Ambien CR in the pediatric
population based on these efficacy and safety findings.
Geriatric useA total of 99 elderly (≥ 65 years of age)
received daily doses of 6.25 mg Ambien CR in a 3-week
placebo-controlled study. The adverse reaction profile of
Ambien CR 6.25 mg in this population was similar to that of
Ambien CR 12.5 mg in younger adults (≤ 64 years of age).
Dizziness was reported in 8% of Ambien CR-treated patients
compared with 3% of those treated with placebo. The dose of
Ambien CR in elderly patients is 6.25 mg to minimize adverse
effects related to impaired motor and/or cognitive
performance and unusual sensitivity to sedative/hypnotic
drugs
DRUG ABUSE
AND DEPENDENCE
Controlled
substance Zolpidem tartrate is classified as a Schedule IV
controlled substance by federal regulation. Abuse and
addiction are separate and distinct from physical dependence
and tolerance. Abuse is characterized by misuse of the drug
for non-medical purposes, often in combination with other
psychoactive substances. Tolerance is a state of adaptation
in which exposure to a drug induces changes that result in a
diminution of one or more of the drug effects over time.
Tolerance may occur to both desired and undesired effects of
drugs and may develop at different rates for different
effects.
Addiction is a
primary, chronic, neurobiological disease with genetic,
psychosocial, and environmental factors influencing its
development and manifestations. It is characterized by
behaviors that include one or more of the following:
impaired control over drug use, compulsive use, continued
use despite harm, and craving. Drug addiction is a treatable
disease, using a multidisciplinary approach, but relapse is
common.
Studies of
abuse potential in former drug abusers found that the
effects of single doses of zolpidem tartrate 40 mg were
similar, but not identical, to diazepam 20 mg, while
zolpidem tartrate 10 mg effects were difficult to
distinguish from placebo.
Because persons
with a history of addiction to, or abuse of, drugs or
alcohol are at increased risk for misuse, abuse and
addiction of zolpidem, they should be monitored carefully
when receiving zolpidem or any other hypnotic.
Dependence
Physical dependence is a state of adaptation that is
manifested by a specific withdrawal syndrome that can be
produced by abrupt cessation, rapid dose reduction,
decreasing blood level of the drug, and/or administration of
an antagonist. Sedative/hypnotics have produced withdrawal
signs and symptoms following abrupt discontinuation. These
reported symptoms range from mild dysphoria and insomnia to
a withdrawal syndrome that may include abdominal and muscle
cramps, vomiting, sweating, tremors, and convulsions. The
following adverse events, which are considered to meet the
DSM-III-R criteria for uncomplicated sedative/hypnotic
withdrawal, were reported during U.S. clinical trials
following placebo substitution occurring within 48 hours
following last zolpidem treatment: fatigue, nausea,
flushing, lightheadedness, uncontrolled crying, emesis,
stomach cramps, panic attack, nervousness, and abdominal
discomfort. These reported adverse events occurred at an
incidence of 1% or less. However, available data cannot
provide a reliable estimate of the incidence, if any, of
dependence during treatment at recommended doses.
Post-marketing reports of abuse, dependence and withdrawal
have been received.
OVERDOSAGE
Signs and symptoms in postmarketing
experience of overdose with zolpidem tartrate alone, or in
combination with CNS-depressant agents, impairment of
consciousness ranging from somnolence to coma,
cardiovascular and/or respiratory compromise and fatal
outcomes have been reported.
Recommended
treatment General symptomatic and supportive measures should
be used along with immediate gastric lavage where
appropriate. Intravenous fluids should be administered as
needed. Zolpidem's sedative hypnotic effect was shown to be
reduced by flumazenil and therefore may be useful; however,
flumazenil administration may contribute to the appearance
of neurological symptoms (convulsions). As in all cases of
drug overdose, respiration, pulse, blood pressure, and other
appropriate signs should be monitored and general supportive
measures employed. Hypotension and CNS depression should be
monitored and treated by appropriate medical intervention.
Sedating drugs should be withheld following zolpidem
overdosage, even if excitation occurs. The value of dialysis
in the treatment of overdosage has not been determined,
although hemodialysis studies in patients with renal failure
receiving therapeutic doses have demonstrated that zolpidem
is not dialyzable. As with the management of all overdosage,
the possibility of multiple drug ingestion should be
considered. The physician may wish to consider contacting a
poison control center for up-to-date information on the
management of hypnotic drug product overdosage.
DESCRIPTION
Ambien CR contains zolpidem tartrate, a
non-benzodiazepine hypnotic of the imidazopyridine class.
Ambien CR (zolpidem tartrate extended-release tablets) is
available in 6.25 mg and 12.5 mg strength tablets for oral
administration.Chemically, zolpidem is
N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide
L-(+)-tartrate (2:1). It has the following
structure:Zolpidem tartrate is a white to off-white
crystalline powder that is sparingly soluble in water,
alcohol, and propylene glycol. It has a molecular weight of
764.88.Ambien CR consists of a coated two-layer tablet: one
layer that releases its drug content immediately and another
layer that allows a slower release of additional drug
content. The 6.25 mg Ambien CR tablet contains the following
inactive ingredients: colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, potassium
bitartrate, red ferric oxide, sodium starch glycolate, and
titanium dioxide. The 12.5 mg Ambien CR tablet contains the
following inactive ingredients: colloidal silicon dioxide,
FD&C Blue #2, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
potassium bitartrate, sodium starch glycolate, titanium
dioxide, and yellow ferric oxide.
CLINICAL
PHARMACOLOGY Mechanism of action Zolpidem, the active
moiety of zolpidem tartrate, is a hypnotic agent with a
chemical structure unrelated to benzodiazepines,
barbiturates, or other drugs with known hypnotic properties.
It interacts with a GABA-BZ receptor complex and shares some
of the pharmacological properties of the benzodiazepines. In
contrast to the benzodiazepines, which non-selectively bind
to and activate all BZ receptor subtypes, zolpidem in vitro
binds the BZ1 receptor preferentially with a high affinity
ratio of the
α1/α5 subunits.
This selective binding of zolpidem on the BZ1 receptor is
not absolute, but it may explain the relative absence of
myorelaxant and anticonvulsant effects in animal studies as
well as the preservation of deep sleep (stages 3 and 4) in
human studies of zolpidem tartrate at hypnotic doses.
Pharmacokinetics Ambien CR exhibits biphasic absorption
characteristics, which results in rapid initial absorption
from the gastrointestinal tract similar to zolpidem tartrate
immediate-release, then provides extended plasma
concentrations beyond three hours after administration. A
study in 24 healthy male subjects was conducted to compare
mean zolpidem plasma concentration-time profiles obtained
after single oral administration of Ambien CR 12.5 mg and of
an immediate-release formulation of zolpidem tartrate (10
mg). The terminal elimination half-life observed with Ambien
CR (12.5 mg) was similar to that obtained with
immediate-release zolpidem tartrate (10 mg). The mean plasma
concentration-time profiles are shown in Figure 1.Figure 1:
Mean plasma concentration-time profiles for Ambien CR (12.5
mg) and immediate-release zolpidem tartrate (10 mg)In adult
and elderly patients treated with Ambien CR, there was no
evidence of accumulation after repeated once-daily dosing
for up to two weeks.
Absorption:
Following administration of Ambien CR, administered as a
single 12.5 mg dose in healthy male adult subjects, the mean
peak concentration (Cmax) of zolpidem was 134 ng/mL (range:
68.9 to 197 ng/ml) occurring at a median time (Tmax) of 1.5
hours. The mean AUC of zolpidem was 740 ng∙hr/mL (range: 295
to 1359 ng∙hr/mL).A food-effect study in 45 healthy subjects
compared the pharmacokinetics of Ambien CR 12.5 mg when
administered while fasting or within 30 minutes after a
meal. Results demonstrated that with food, mean AUC and Cmax
were decreased by 23% and 30%, respectively, while median
Tmax was increased from 2 hours to 4 hours. The half-life
was not changed. These results suggest that, for faster
sleep onset, Ambien CR should not be administered with or
immediately after a meal. Distribution:
Total protein
binding was found to be 92.5 ± 0.1% and remained constant,
independent of concentration between 40 and 790 ng/mL.Metabolism:Zolpidem
is converted to inactive metabolites that are eliminated
primarily by renal excretion.
Elimination:
When Ambien CR was administered as a single 12.5 mg dose in
healthy male adult subjects, the mean zolpidem elimination
half-life was 2.8 hours (range: 1.62 to 4.05 hr).
Special
Populations Elderly: In 24 elderly (≥ 65 years) healthy
subjects administered a single 6.25 mg dose of Ambien CR,
the mean peak concentration (Cmax) of zolpidem was 70.6
(range: 35.0 to 161) ng/mL occurring at a median time (Tmax)
of 2.0 hours. The mean AUC of zolpidem was 413 ng∙hr/mL
(range: 124 to 1190 ng∙hr/mL) and the mean elimination
half-life was 2.9 hours (range: 1.59 to 5.50 hours).
Hepatic
Impairment: Ambien CR was not studied in patients with
hepatic impairment. The pharmacokinetics of an
immediate-release formulation of zolpidem tartrate in eight
patients with chronic hepatic insufficiency were compared to
results in healthy subjects. Following a single 20-mg oral
zolpidem tartrate dose, mean Cmax and AUC were found to be
two times (250 vs. 499 ng/mL) and five times (788 vs. 4,203
ng∙hr/mL) higher, respectively, in hepatically compromised
patients. Tmax did not change. The mean half-life in
cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was
greater than that observed in normal subjects of 2.2 hr
(range: 1.6 to 2.4 hr). Dosing should be modified
accordingly in patients with hepatic insufficiency
Renal
Impairment: Ambien CR was not studied in patients with renal
impairment. The pharmacokinetics of an immediate-release
formulation of zolpidem tartrate were studied in 11 patients
with end-stage renal failure (mean ClCr = 6.5 ± 1.5 mL/min)
undergoing hemodialysis three times a week, who were dosed
with zolpidem tartrate 10 mg orally each day for 14 or 21
days. No statistically significant differences were observed
for Cmax, Tmax, half-life, and AUC between the first and
last day of drug administration when baseline concentration
adjustments were made. On day 1, Cmax was 172 ± 29 ng/mL
(range: 46 to 344 ng/mL). After repeated dosing for 14 or 21
days, Cmax was 203 ± 32 ng/mL (range: 28 to 316 ng/mL). On
day 1, Tmax was 1.7 ± 0.3 hr (range: 0.5 to 3.0 hr); after
repeated dosing Tmax was 0.8 ± 0.2 hr (range: 0.5 to 2.0
hr). This variation is accounted for by noting that last-day
serum sampling began 10 hours after the previous dose,
rather than after 24 hours. This resulted in residual drug
concentration and a shorter period to reach maximal serum
concentration. On day 1, T1/2 was 2.4 ± 0.4 hr (range: 0.4
to 5.1 hr). After repeated dosing, T1/2 was 2.5 ± 0.4 hr
(range: 0.7 to 4.2 hr). AUC was 796 ± 159 ng∙hr/mL after the
first dose and 818 ± 170 ng∙hr/mL after repeated dosing.
Zolpidem was not hemodialyzable. No accumulation of
unchanged drug appeared after 14 or 21 days. Zolpidem
pharmacokinetics were not significantly different in renally-impaired
patients. No dosage adjustment is necessary in patients with
compromised renal function. However, as a general
precaution, these patients should be closely monitored.
NONCLINICAL
TOXICOLOGY
Carcinogenesis,
mutagenesis, impairment of fertility Carcinogenesis:
Zolpidem was administered to mice and rats for 2 years at
dietary dosages of 4, 18, and 80 mg base/kg. In mice, these
doses are approximately 2, 9, and 40 times the maximum
recommended human dose (MRHD) of 12.5 mg/day (10 mg zolpidem
base) on mg/m2 basis. In rats, these doses are approximately
4, 18, and 80 times the MRHD on a mg/m2 basis. No evidence
of carcinogenic potential was observed in mice. In rats,
renal tumors (lipoma, liposarcoma) were seen at the mid- and
high doses.
Mutagenesis:
Zolpidem was negative in in vitro (bacterial reverse
mutation, mouse lymphoma, and chromosomal aberration) and in
vivo (mouse micronucleus) genetic toxicology assays.
Impairment of
fertility: Oral administration of zolpidem (doses of 4, 20,
and 100 mg base/kg or approximately 4, 20, and 100 times the
MRHD on a mg/m2 basis) to rats prior to and during mating,
and continuing in females through postpartum day 25,
resulted in irregular estrus cycles and prolonged precoital
intervals. The no-effect dose for these findings is
approximately 20 times the MRHD on a mg/m2 basis. There was
no impairment of fertility at any dose tested
Ambien
withdrawal. Ambien withdrawal side effects, Ambien
withdrawal warnings, Ambien withdrawal precautions, Ambien
withdrawal adverse effects, overdose, withdrawal symptoms
and Ambien natural alternatives. Before you begin the spiral
down with Ambien, try giving your body what it really wants.
Body
Ambien withdrawal - Dry Mouth
- The usual amount to moisture in the
mouth is noticeably less.
Ambien
withdrawal - Sweating Increased
- A large
quantity of perspiration that is medically caused.
Cardiovascular (Involving the heart and the blood
vessels)
Ambien
withdrawal - Palpitation - Unusual and
not normal heartbeat, that is sometimes irregular, but rapid
and forceful thumping or fluttering. It can be brought on by
shock, excitement, exertion, or medical stimulants. A person
is normally unaware of his/her heartbeat.
Ambien
withdrawal - Hypertension - is high blood pressure, which is a
symptom of disease in the blood vessels leading away from
the heart. Hypertension is known as the “silent killer”. The
symptoms are usually not obvious, however it can lead to
damage to the heart, brain, kidneys and eye, and even to
stroke and kidney failure. Treatment includes dietary and
lifestyle changes.
Ambien
withdrawal - Bradycardia - The heart
rate is slowed from 72 beats per minute, which is normal, to
below 60 beats per minute in an adult.
Ambien
withdrawal - Tachycardia - The heart
rate is speeded up to above 100 beats per minute in an
adult. Normal adult heart rate is 72 beats per minute.
Ambien
withdrawal - ECG Abnormal
- A test called
an electrocardiogram (ECG) that records the activity of the
heart. It measures heartbeats as will as the position and
size of the heart’s four chambers. It also measures if there
is damage to the heart and the effects of drugs or
mechanical devices like a pacemaker on the heart. When the
test is abnormal this means that one or more of the
following are present: heart disease, defects, beating too
fast or too slow, disease of the blood vessels leading from
the heart or of the heart valves, and/or a past or about to
occur heart attack.
Ambien
withdrawal - Flushing - The skin all
over the body turns red.
Ambien
withdrawal - Varicose Vein - Unusually
swollen veins near the surface of the skin that sometimes
appear twisted and knotted, but always enlarged. They are
called hemorrhoids when they appear around the rectum. The
cause is attributed to hereditary weakness in the veins
aggravated by obesity, pregnancy, pressure from standing,
aging, etc. Severe cases may develop swelling in the legs,
ankles and feet, eczema and/or ulcers in the affected areas.
Gastrointestinal
(Involving the stomach and the
intestines)
Ambien
withdrawal - Abdominal Cramp/Pain - Sudden,
severe, uncontrollable and painful shortening and thickening
of the muscles in the belly. The belly includes the stomach
as well as the intestines, liver, kidneys, pancreas, spleen,
gall bladder, and urinary bladder.
Ambien
withdrawal - Belching
- Noisy release
of gas from the stomach through the mouth; a burp.
Ambien
withdrawal - Bloating - Swelling of
the belly caused by excessive intestinal gas.
Ambien
withdrawal - Constipation - Difficulty
in having a bowel movement where the material in the bowels
is hard due to a lack of exercise, fluid intake, and
roughage in the diet, or due to certain drugs.
Ambien
withdrawal - Diarrhea - Unusually
frequent and excessive, runny bowel movements that may
result in severe dehydration and shock.
Ambien
withdrawal - Dyspepsia - Indigestion.
This is the discomfort you experience after eating. It can
be heartburn, gas, nausea, a bellyache or bloating.
Ambien
withdrawal - Flatulence - More gas
than normal in the digestive organs.
Ambien
withdrawal - Gagging
- Involuntary
choking and/or involuntary throwing up.
Ambien
withdrawal - Gastritis
- A severe
irritation of the mucus lining of the stomach either short
in duration or lasting for a long period of time.
Ambien
withdrawal - Gastroenteritis
- A condition
where the membranes of the stomach and intestines are
irritated.
Ambien
withdrawal - Gastroesophageal Reflux -
A continuous state where stomach juices flow back into the
throat causing acid indigestion and heartburn and possibly
injury to the throat.
Ambien
withdrawal - Heartburn - A burning
pain in the area of the breastbone caused by stomach juices
flowing back up into the throat.
Ambien
withdrawal - Hemorrhoids - Small
rounded purplish swollen veins that either bleed, itch or
are painful and appear around the anus.
Ambien
withdrawal - Increased Stool frequency -
Diarrhea.
Ambien
withdrawal - Indigestion - Unable to
properly consume and absorb food in the digestive tract
causing constipation, nausea, stomach ache, gas, swollen
belly, pain and general discomfort or sickness.
Ambien
withdrawal - Nausea - Stomach
irritation with a queasy sensation similar to motion
sickness and a feeling that one is going to vomit.
Ambien
withdrawal - Polyposis Gastric
- Tumors that
grow on stems in the lining of the stomach, which usually
become cancerous.
Ambien
withdrawal - Swallowing Difficulty - A feeling
that food is stuck in the throat or upper chest area and
won’t go down, making it difficult to swallow.
Ambien
withdrawal - Toothache - Pain in a
tooth above and below the gum line.
Ambien
withdrawal - Vomiting -
Involuntarily throwing up the contents of the stomach and
usually getting a nauseated, sick feeling just prior to
doing so.
General
Ambien
withdrawal - Allergy - The extreme
sensitivity of body tissues triggered by substances in the
air, drugs, or foods causing a reaction like sneezing,
itching, asthma, hay fever, skin rashes, nausea and/or
vomiting.
Ambien
withdrawal - Anaphylaxis - A violent,
sudden, and severe drop in blood pressure caused by a
re-exposure to a foreign protein or a second dosage of a
drug that may be fatal unless emergency treatment is given
right away.
Ambien
withdrawal - Asthenia
- A physically
weak condition.
Ambien
withdrawal - Chest Pains - Severe
discomfort in the chest caused by not enough oxygen going to
the heart because of narrowing of the blood vessels or
spasms.
Ambien
withdrawal - Chills - Appearing
pale while cold and shivering; sometimes with a fever.
Ambien
withdrawal - Edema of Extremities
- Abnormal
swelling of the body’s tissue caused by the collection of
fluid.
Ambien
withdrawal - Fall
- To suddenly
lose your normal standing upright position as if you were
shot.
Ambien
withdrawal - Fatigue - Loss of
normal strength so as to not be able to do the usual
physical and mental activities.
Ambien
withdrawal - Fever
- Abnormally
high body temperature, the normal being 98 degrees
Fahrenheit or 37 degrees Centigrade in humans, which is a
symptom of disease or disorder in the body. The body is
affected by feeling hot, chilled, sweaty, weak and
exhausted. If the fever goes too high, death can result.
Ambien
withdrawal - Hot Flashes - Brief,
abnormal enlargement of the blood vessels that causes a
sudden heat sensation over the entire body. Women in
menopause will sometimes experience this.
Ambien
withdrawal - Influenza-like Symptoms
- Demonstrating irritation of the respiratory tract (organs
of breathing) such as a cold, sudden fever, aches and pains,
as well as feeling weak and seeking bed rest, which is
similar to having the flu.
Ambien
withdrawal - Leg Pain - A hurtful
sensation in the legs that is caused by excessive
stimulation of the nerve endings in the legs and results in
extreme discomfort.
Ambien
withdrawal - Malaise
- The somewhat
unclear feeling of discomfort you get when you start to feel
sick.
Ambien
withdrawal - Pain in Limb - Sudden,
sharp and uncontrolled leg discomfort.
Ambien
withdrawal - Syncope - A short
period of light headedness or unconsciousness (black-out)
also know as fainting caused by lack of oxygen to the brain
because of an interruption in blood flowing to the brain.
Ambien
withdrawal - Tightness of Chest
- Mild or sharp
discomfort, tightness or pressure in the chest area
(anywhere between the throat and belly). The causes can be
mild or seriously life-threatening because they include the
heart, lungs and surrounding muscles.
Hemic and
Lymphatic Disorders (Involving the
blood and the clear fluids in the tissues that contain white
blood cells)
Ambien
withdrawal - Bruise - Damage to
the skin resulting in a purple-green-yellow skin coloration
that’s caused by breaking the blood vessels in the area
without breaking the surface of the skin.
Ambien
withdrawal - Anemia - A condition
where the blood is no longer carrying enough oxygen, so the
person looks pale and easily gets dizzy, weak and tired.
More severely, a person can end up with an abnormal heart,
as well as breathing and digestive difficulties. The causes
of anemia are not enough protein in the red blood cells, or
missing and chemically destroyed red blood cells, as well as
diseased or destroyed bone marrow.
Ambien
withdrawal - Nosebleed
- Blood lost
from the part of the face that has the organs of smell and
is where the body takes in oxygen.
Ambien
withdrawal - Hematoma - Broken blood
vessels that cause a swelling in an area on the body.
Ambien
withdrawal - Lymphadenopathy Cervical
- The lymph nodes in the neck, which are part of the body’s
immune system get swollen and enlarge by reacting to the
presence of a drug. The swelling is the result of the white
blood cells multiplying in order to fight the invasion of
the drug.
Metabolic and
Nutritional Disorders (Energy
and health)
Ambien
withdrawal - Arthralgia - Sudden sharp
nerve pain in one or more joints.
Ambien
withdrawal - Arthropathy - Having joint
disease or abnormal joints.
Ambien
withdrawal - Arthritis - Painfully
inflamed and swollen joints. The reddened and swollen
condition is brought on by a serious injury or shock to the
body either from physical or emotional causes.
Ambien
withdrawal - Back Discomfort
- Severe
physical distress in the area from the neck to the pelvis
along the backbone.
Ambien
withdrawal - Bilirubin Increased - Bilirubin is
a waste product of the breakdown of old blood cells.
Bilirubin is sent to the liver to be made water-soluble so
it can be eliminated from the body through emptying the
bladder. A drug can interfere with or damage this normal
liver function creating liver disease.
Ambien
withdrawal - Decreased Weight -
Uncontrolled and measured loss of heaviness or weight.
Ambien
withdrawal - Gout
- A severe
arthritis condition that is caused by the dumping of a waste
product called uric acid in the tissues and joints. It can
become worse and cause the body to develop a deformity after
going through stages of pain, inflammation, severe
tenderness, and stiffness.
Ambien
withdrawal - Hepatic Enzymes Increased -
An increase in the amount of paired liver proteins that
regulate liver processes causing a condition where the liver
functions abnormally.
Ambien
withdrawal - Hypercholesterolemia
- Too much
cholesterol in the blood cells.
Ambien
withdrawal - Hyperglycemia
- An unhealthy
amount of sugar in the blood.
Ambien
withdrawal - Increased Weight - A
concentration and storage of fat in the body accumulating
over a period of time caused by unhealthy eating patterns,
that can predispose the body to many disorders and diseases.
Ambien
withdrawal - Jaw Pain - The pain due
to irritation and swelling of the nerves associated with the
mouth area where it opens and closes just in front of the
ear. Some of the symptoms are pain when chewing, headaches,
losing your balance, stuffy ears or ringing in the ears, and
teeth grinding.
Ambien
withdrawal - Jaw Stiffness - The result
of squeezing and grinding the teeth while asleep that can
cause your teeth to deteriorate as well as the muscles and
joints of the jaw.
Ambien
withdrawal - Joint Stiffness
- A loss of
free motion and easy flexibility where any two bones come
together.
Ambien
withdrawal - Muscle Cramp - When muscles
contract uncontrollably without warning and do not relax.
The muscles of any of the body’s organs can cramp.
Ambien
withdrawal - Muscle Stiffness
- Tightening of
muscles making it difficult to bend.
Ambien
withdrawal - Muscle Weakness - Loss of
physical strength.
Ambien
withdrawal - Myalgia
- A general
widespread pain and tenderness of the muscles.
Ambien
withdrawal - Thirst
- A strong,
unnatural craving for moisture/water in the mouth and
throat.
Nervous
System
(Sensory channels)
Ambien
withdrawal - Carpal Tunnel Syndrome -
A pinched nerve in the wrist that causes pain, tingling, and
numbing.
Ambien
withdrawal - Coordination Abnormal
- A lack of normal, harmonious interaction of the parts of
the body when it is in motion
Ambien
withdrawal - Dizziness - Losing one’s
balance while feeling unsteady and lightheaded which may
lead to fainting.
Ambien
withdrawal - Disequilibrium - Lack of
mental and emotional balance.
Ambien
withdrawal - Faintness
- A temporary
condition where one is likely to go unconscious and fall.
Ambien
withdrawal - Headache - A sharp or
dull persistent pain in the head
Ambien
withdrawal - Hyperreflexia
- A not normal
and involuntary increased response in the tissues connecting
the bones to the muscles.
Ambien
withdrawal - Light-headed Feeling
– Uncontrolled
and usually brief loss of consciousness caused by lack of
oxygen to the brain.
Ambien
withdrawal - Migraine - Reoccurring
severe head pain usually with nausea, vomiting, dizziness,
flashes or spots before the eyes, and ringing in the ears
Ambien
withdrawal - Muscle Contractions Involuntary - Spontaneous and uncontrollable tightening reaction of the
muscles caused by electrical impulses from the nervous
system.
Ambien
withdrawal - Muscular Tone Increased -
Uncontrolled and exaggeration muscle tension. Muscles are
normally partially tensed and this is what gives us muscle
tone.
Ambien
withdrawal - Paresthesia
- Burning,
prickly, itchy, or tingling skin with no obvious or
understood physical cause.
Ambien
withdrawal - Restless Legs - A need to
move the legs without any apparent reason. Sometimes there
is pain, twitching, jerking, cramping, burning, or a
creepy-crawly sensation associated with the movements. It
worsens when a person is inactive and can interrupt one’s
sleep so one feels the need to move to gain some relief.
Ambien
withdrawal - Shaking
- Uncontrolled
quivering and trembling as if one is cold and chilled.
Ambien
withdrawal - Sluggishness
- Lack of
alertness and energy, as well as being slow to respond or
perform in life.
Ambien
withdrawal - Tics - A contraction of a muscle causing a
repeated movement not under the control of the person
usually on the face or limbs.
Ambien
withdrawal - Tremor - A nervous and
involuntary vibrating or quivering of the body.
Ambien
withdrawal - Twitching
- Sharp, jerky
and spastic motion sometimes with a sharp sudden pain.
Ambien
withdrawal - Vertigo - A sensation
of dizziness with disorientation and confusion.
Psychiatric
Disorders (Mental and emotional)
Ambien
withdrawal - Aggravated Nervousness
- A progressively worsening, irritated and troubled state of
mind.
Ambien
withdrawal - Agitation - Suddenly
violent and forceful, emotionally disturbed state of mind.
Ambien
withdrawal - Amnesia - Long term or
short term, partial or full memory loss created by emotional
or physical shock, severe illness, or a blow to the head
where the person was caused pain and became unconsciousness.
Ambien
withdrawal - Anxiety Attack - Sudden and
intense feelings of fear, terror, and dread physically
creating shortness of breath, sweating, trembling and heart
palpitations.
Ambien
withdrawal - Apathy - Complete
lack of concern or interest for things that ordinarily would
be regarded as important or would normally cause concern.
Ambien
withdrawal - Appetite Decreased - Having a
lack of appetite despite the ordinary caloric demands of
living with a resulting unintentional loss of weight.
Ambien
withdrawal - Appetite Increased
- An unusual
hunger causing one to overeat.
Ambien
withdrawal - Auditory Hallucination -
Hearing things without the voices or noises being present.
Ambien
withdrawal - Bruxism - Grinding and
clenching of teeth while sleeping.
Ambien
withdrawal - Carbohydrate Craving - A drive and
craving to eat foods rich in sugar and starches (sweets,
snacks and junk foods) that intensifies as the diet becomes
more and more unbalanced due to the unbalancing of the
proper nutritional requirements of the body.
Ambien
withdrawal - Concentration Impaired -
Unable to easily focus your attention for long periods of
time.
Ambien
withdrawal - Confusion - Not able to
think clearly and understand in order to make a logical
decision.
Ambien
withdrawal - Crying Abnormal
- Unusual and
not normal fits of weeping for short or long periods of time
for no apparent reason.
Ambien
withdrawal - Depersonalization - A condition
where one has lost a normal sense of personal identity.
Ambien
withdrawal - Depression - A hopeless
feeling of failure, loss and sadness that can deteriorate
into thoughts of death.
Ambien
withdrawal - Disorientation - A loss of
sense of direction, place, time or surroundings as well as
mental confusion on personal identity.
Ambien
withdrawal - Dreaming Abnormal
- Dreaming that
leaves a very clear, detailed picture and impression when
awake that can last for a long period of time and sometimes
be unpleasant.
Ambien
withdrawal - Emotional Lability - Suddenly
breaking out in laughter or crying or doing both without
being able to control the outburst of emotion. These
episodes are unstable as they are caused by things that
normally would not have this effect on an individual.
Ambien
withdrawal - Excitability -
Uncontrollably responding to stimuli.
Ambien
withdrawal - Feeling Unreal
- The awareness
that one has an undesirable emotion like fear but can’t seem
to shake off the irrational feeling. For example, feeling
like one is going crazy but rationally knowing that it is
not true. The quality of this side effect resembles being in
a bad dream and not being able to wake up.
Ambien
withdrawal - Forgetfulness
- Unable to
remember what one ordinarily would remember.
Ambien
withdrawal - Insomnia -
Sleeplessness caused by physical stress, mental stress or
stimulants such as coffee or medications; it is a condition
of being abnormally awake when one would ordinarily be able
to fall and remain asleep.
Ambien
withdrawal - Irritability - Abnormally
annoyed in response to a stimulus.
Ambien
withdrawal - Jitteriness
- Nervous
fidgeting without an apparent cause.
Ambien
withdrawal - Lethargy
- Mental and
physical sluggishness and apathy that can deteriorate into
an unconscious state resembling deep sleep. A numbed state
of mind.
Ambien
withdrawal - Libido Decreased - An abnormal
loss of sexual energy or desire.
Ambien
withdrawal - Panic Reaction - A sudden,
overpowering, chaotic and confused mental state of terror
resulting in being doubt ridden often accompanied with
hyperventilation, and extreme anxiety.
Ambien
withdrawal - Restlessness Aggravated
- A constantly worsening troubled state of mind
characterized by the person being increasingly nervous,
unable to relax, and easily angered.
Ambien
withdrawal - Somnolence - Feeling
sleepy all the time or having a condition of
semi-consciousness.
Ambien
withdrawal - Suicide Attempt
- An
unsuccessful deliberate attack on one’s own life with the
intention of ending it.
Ambien
withdrawal - Suicidal Tendency - Most likely
will attempt to kill oneself.
Ambien
withdrawal - Tremulousness Nervous - Very jumpy,
shaky, and uneasy while feeling fearful and timid. The
condition is characterized by thoughts of dreading the
future, involuntary quivering, trembling, and feeling
distressed and suddenly upset.
Ambien
withdrawal - Yawning
- involuntary
opening of the mouth with deep inhalation of air.
Reproductive
Disorder Female
Ambien
withdrawal - Breast Neoplasm
- A tumor or
cancer, of either of the two milk-secreting organs on the
chest of a woman.
Ambien
withdrawal - Menorrhagia
- Abnormally
heavy menstrual period or a menstrual flow that has
continued for an unusually long period of time.
Ambien
withdrawal - Menstrual Cramps
- Painful,
involuntary uterus contractions that women experience around
the time of their menstrual period, sometimes causing pain
in the lower back and thighs.
Ambien
withdrawal - Menstrual Disorder - A
disturbance or derangement in the normal function of a
woman’s menstrual period.
Ambien
withdrawal - Pelvic Inflammation
- The reaction
of the body to infectious, allergic, or chemical irritation,
which in turn causes tissue irritation, injury, or bacterial
infection characterized by pain, redness, swelling, and
sometimes loss of function. The reaction usually begins in
the uterus and spreads to the fallopian tubes, ovaries, and
other areas in the hipbone region of the body.
Ambien
withdrawal - Premenstrual Syndrome - Various
physical and mental symptoms commonly experienced by women
of childbearing age usually 2 to 7 days before the start of
their monthly period. There are over 150 symptoms including
eating binges, behavioral changes, moodiness, irritability,
fatigue, fluid retention, breast tenderness, headaches,
bloating, anxiety, and depression. The symptoms cease
shortly after the period begins, and disappear with
menopause.
Ambien
withdrawal - Spotting Between Menses -
Abnormal bleeding between periods. Unusual spotting between
menstrual cycles.
Respiratory
System (Organs involved in breathing)
Ambien
withdrawal - Asthma - A disease of
the breathing system initiated by and allergic reaction or a
chemical with repeated attacks of coughing, sticky mucus,
wheezing, shortness of breath, and a tight feeling in the
chest. The disease can reach a state where it stops a person
from exhaling, leading to unconsciousness and death.
Ambien
withdrawal - Breath Shortness
- Unnatural
breathing using a lot off effort resulting in not enough air
taken in by the body.
Ambien
withdrawal - Bronchitis
- Inflammation
of the two main breathing tubes leading from the windpipe to
the lungs. The disease is marked with coughing, a low-grade
fever, chest pains, and hoarseness, caused by an allergic
reaction.
Ambien
withdrawal - Coughing - A cough is
the response to an irritation, such as mucus, that causes
the muscles controlling the breathing process to expel air
from the lungs suddenly and noisily to keep the air passages
free from the irritating material.
Ambien
withdrawal - Laryngitis - Inflammation
of the voice box characterized by hoarseness, sore throat,
and coughing. It can be cause by straining the voice or
exposure to infectious, allergic or chemical irritation.
Ambien
withdrawal - Nasal Congestion - The presence
of an abnormal amount of fluid in the nose.
Ambien
withdrawal - Pneumonia Tracheitis - Bacterial
infection of the air passageways and lungs that causes
redness, swelling and pain in the windpipe. Other symptoms
are high fever, chills, pain in the chest, difficulty in
breathing, and coughing with mucus discharge
Ambien
withdrawal - Rhinitis - Chemical
irritation causing pain, redness and swelling in the mucus
membranes of the nose.
Ambien
withdrawal - Sinus Congestion - The
mucus-lined areas of the bones in the face that are thought
to help warm and moisten air to the nose. These areas become
clogged with excess fluid or infected.
Ambien
withdrawal - Sinus Headache - The abnormal
amount of fluid in the hollows of the face bone area
especially around the nose. This excess fluid creates
pressure, causing pain in the head.
Ambien
withdrawal - Sinusitis - The body
reacting to chemical irritation causing redness, swelling
and pain in the area of the hollows in the facial bones
especially around the nose.
SkeletalAmbien withdrawal - Neck/Shoulder Pain - Hurtful sensations of the nerve
endings caused by damage to the tissues in the neck and
shoulder signaling danger of disease.
Skin and
Appendages Disorders (Skin, legs
and arms)
Ambien
withdrawal - Acne - Eruptions of the oils glands of the
skin, especially on the face, marked by pimples, blackheads,
whiteheads, bumps, and more severely, by cysts and scarring.
Ambien
withdrawal - Alopecia
- The loss of
hair or baldness.
Ambien
withdrawal - Eczema - A severe or
continuing skin disease marked by redness, crusting and
scaling with watery blisters and itching. It is often
difficult to treat and will sometimes go away only to
reappear again.
Ambien
withdrawal - Dermatitis - Generally
irritated skin that can be caused by any of a number of
irritating things such as parasites, fungus, bacteria, or
foreign substances causing an allergic reaction. It is a
general inflammation of the skin.
Ambien
withdrawal - Dry Lips - The lack of
normal moisture in the fleshy folds that surround the mouth.
Ambien
withdrawal - Dry Skin
- The lack of
normal moisture/oils in the surface layer of the body. The
skin is the body’s largest organ.
Ambien
withdrawal - Folliculitis - Inflammation
of a follicle (small body sac) especially a hair follicle. A
hair follicle contains the root of a hair.
Ambien
withdrawal - Furunculosis - Skin boils
that show up repeatedly.
Ambien
withdrawal - Lipoma - A tumor of
mostly fat cells that is not health endangering.
Ambien
withdrawal - Pruritus - Extreme
itching of often-undamaged skin.
Ambien
withdrawal - Rash
- A skin
eruption or discoloration that may or may not be itching,
tingling, burning, or painful. It may be caused by an
allergy, an skin irritation, a skin disease.
Ambien
withdrawal - Skin Nodule - A bulge,
knob, swelling or outgrowth in the skin that is a mass of
tissue or cells.
Special
Senses
Ambien
withdrawal - Conjunctivitis - Infection of
the membrane that covers the eyeball and lines the eyelid,
caused by a virus, allergic reaction, or an irritating
chemical. It is characterized by redness, a discharge of
fluid and itching.
Ambien
withdrawal - Dry Eyes - Not enough
moisture in the eyes.
Ambien
withdrawal - Earache - Pain in the
ear.
Ambien
withdrawal - Eye Infection - The invasion
of the eye tissue by a bacteria, virus, fungus, etc, causing
damage to the tissue, with toxicity. Infection spreading in
the body progresses into disease.
Ambien
withdrawal - Eye Irritation - An
inflammation of the eye.
Ambien
withdrawal - Metallic Taste
- A range of
taste impairment from distorted taste to a complete loss of
taste.
Ambien
withdrawal - Pupils Dilated
- Abnormal
expansion of the blace circular opening in the center of the
eye.
Ambien
withdrawal - Taste alteration - Abnormal
flavor detection in food.
Ambien
withdrawal - Tinnitus - A buzzing,
ringing, or whistling sound in one or both ears occurring
from the internal use of certain drugs.
Ambien
withdrawal - Vision Abnormal - Normal
images are seen differently by the viewer.
Ambien
withdrawal - Vision Blurred - Eyesight is
dim or indistinct and hazy in outline or appearance.
Ambien
withdrawal - Visual Disturbance - Eyesight is
interfered with or interrupted. Some disturbances are light
sensitivity and the inability to easily distinguish colors.
Urinary
System Disorder
Ambien
withdrawal - Blood in Urine - Blood is
present when one empties liquid waste product of the kidneys
through the bladder by urinating in the toilet turning the
water pink to bright red. Or you could see pots of blood in
the water after urinating.
Ambien
withdrawal - Dysuria - Difficult or
painful urination.
Ambien
withdrawal - Kidney Stone - Small hard
masses of salt deposits that the kidney forms.
Ambien
withdrawal - Urinary Frequency
- Having to
urinate more often than usual or between unusually short
time periods.
Ambien
withdrawal - Urinary Tract Infection -
An invasion of bacteria, viruses, fungi, etc., of the system
in the body that starts with the kidneys and eliminates
urine from the body. If the invasion goes unchecked it can
injure tissue and progress into disease.
Ambien
withdrawal - Urinary Urgency - A sudden
compelling urge to urinate, accompanied by discomfort in the
bladder.
Urogenital
(Urinary tract and genital structures
or functions)
Ambien
withdrawal - Anorgasmia - Failure to
experience an orgasm.
Ambien
withdrawal - Ejaculation Disorder
- Dysfunction
of the discharge of semen during orgasm.
Ambien
withdrawal - Menstrual Disorder - Dysfunction
of the discharge during the monthly menstrual cycle.
Ambien
withdrawal - Acute Renal Failure
- The kidneys
stop functioning properly to excrete wastes.
Ambien
withdrawal - Angioedema
- Intensely
itching and swelling welts on the skin called hives caused
by an allergic reaction to internal or external agents. The
reaction is common to a food or a drug. Chronic cases can
last for a long period of time.
Ambien
withdrawal - Toxic Epidermal Necrolysis
- An abnormal condition where a large portion of skin
becomes intensely red and peels off like a second-degree
burn. Often the symptoms include blistering.
Ambien
withdrawal - Gastrointestinal Hemorrhage -
Stomach and intestinal excessive internal bleeding.
Ambien
withdrawal - Grand Mal Seizures (or Convulsions)
- A recurring sudden violent and involuntary attack of muscle
spasms with a loss of consciousness.
Ambien
withdrawal - Neuroleptic Malignant Syndrome - A life threatening, rare reaction to an anti-psychotic drug
marked by fever, muscular rigidity, changed mental status,
and dysfunction of the autonomic nervous system.
Ambien
withdrawal - Pancreatitis - Chemical
irritation with redness, swelling, and pain in the pancreas
where digestive enzymes and hormones are secreted.
Ambien
withdrawal - QT Prolongation - A very fast
heart rhythm disturbance that is too fast for the heart to
beat effectively so the blood to the brain falls causing a
sudden loss of consciousness and may cause sudden cardiac
death.
Ambien
withdrawal - Rhabdomyolysis - The
breakdown of muscle fibers that releases the fibers into the
circulatory system. Some of the fibers are poisonous to the
kidney and frequently result in kidney damage.
Ambien
withdrawal - Serotonin Syndrome
- A disorder
brought on by excessive levels of serotonin caused by drugs
and can be fatal as death from this side effect can come
very rapidly.
Ambien
withdrawal - Thrombocytopenia - An abnormal
decrease in the number of blood platelets in the circulatory
system. A decrease in platelets would cause a decrease in
the ability of the blood to clot when necessary.
Ambien
withdrawal - Torsades de Pointes
- Unusual rapid
heart rhythm starting in the lower heart chambers. If the
short bursts of rapid heart rhythm continue for a prolonged
period it can degenerate into a more rapid rhythm and can be
fatal
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