It got so bad that I would do anything to take away panic episodes. I suffer from panic attacks. Use the lowest effective dose for the patient. GABA A receptor positive modulators. Almost killed me 4 times already, the more information the better! Associated with discontinuation of treatment:
Schedule IV 5mg Ambien 10mg Ambien. Extended-release Ambien CR Women: Dosing considerations Ambien, Ambien CR Use lowest effective dose; take only once per night immediately before bedtime with at least hr remaining before the planned time of awakening In some patients, higher morning blood levels following use of 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness Total dose should not exceed 10 mg once daily immediately before bedtime; should be taken as single dose and should not be readministered during same night.
Insomnia Intermezzo Insomnia when a middle of the night awakening is followed by difficulty returning to sleep Women: Dosing Modifications Renal impairment Dose adjustment may not be necessary; monitor. Drug of choice when hypnotic indicated in elderly Insomnia Sleep initiation Immediate-release, oral spray: Insomnia Intermezzo Middle of the night awakening Men and women: Use lowest effective dose; take only once per night immediately before bedtime with at least hr remaining before the planned time of awakening Intermezzo: Significant - Monitor Closely.
All Interactions Sort By: Postmarketing reports Respiratory depression Sublingual tablet: Oral ulcers, blisters, and mucosal inflammation Liver and biliary system: Warnings Contraindications Contraindicated in patients with known hypersensitivity to zolpidem; observed reactions include anaphylaxis and angioedema. Cautions The risk of next-day psychomotor impairment, including impaired driving, is increased if taken with less than a full night of sleep remaining 7 to 8 hours ; if a higher than the recommended dose is taken; if co-administered with other CNS depressants or alcohol; or if co-administered with other drugs that increase blood levels of zolpidem; patients should be warned against driving and other activities requiring complete mental alertness if drug taken in these circumstances Co-administration with other CNS depressants e.
C; cases of severe neonatal respiratory depression reported when zolpidem used near term, especially when taken with other CNS depressants Lactation: Very low amounts secreted in breast milk; effect on infant unknown; use caution; advise mother to observe breastfeeding infant for lethargy, increased sedation, and changes in feeding habits Pregnancy Categories A: Pharmacology Mechanism of Action Imidazopyridine; modulates omega-1 type GABA receptor via selective antagonism, resulting in increased chloride conductance, neuronal hyperpolarization, inhibition of action potential, and a decrease in neuronal excitability that in turn produce sedative and hypnotic effects.
Elimination Half-life Immediate release: Administration Oral Administration Extended-release tablet: Swallow whole; do not chew, crush, or split. Print without Office Info. Print with Office Info. Formulary Formulary Patient Discounts. Create Your List of Plans. View explanations for tiers and restrictions.
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To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization WHO dictionary of preferred terms. The frequencies presented, therefore, represent the proportions of the 3, individuals exposed to Zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving Zolpidem.
All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with Zolpidem tartrate tablets, they were not necessarily caused by it. Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: Body as a whole: Central and peripheral nervous system: Hematologic and lymphatic system: Liver and biliary system: Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.
Similarly, chlorpromazine in combination with Zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance [ see Clinical Pharmacology 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 the absence of an effect following chronic administration [ see Clinical Pharmacology An additive adverse effect on psychomotor performance between alcohol and oral Zolpidem was demonstrated [ see Warnings and Precautions 5. Concomitant administration of Zolpidem and sertraline increases exposure to Zolpidem [ see Clinical Pharmacology There was no evidence of an additive effect in psychomotor performance [ see Clinical Pharmacology The effect of drugs on other P enzymes on the exposure to Zolpidem is not known.
Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of Zolpidem. Use of Rifampin in combination with Zolpidem may decrease the efficacy of Zolpidem. Consideration should be given to using a lower dose of Zolpidem when ketoconazole and Zolpidem are given together. There are no adequate and well-controlled studies of Zolpidem tartrate tablets in pregnant women. 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 risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. Zolpidem tartrate tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Zolpidem tartrate tablets has no established use in labor and delivery [see Pregnancy 8.
Zolpidem is excreted in human milk. Caution should be exercised when Zolpidem tartrate tablets is administered to a nursing woman. Zolpidem tartrate tablets are not recommended for use in children. Safety and effectiveness of Zolpidem in pediatric patients below the age of 18 years have not been established. Ten patients on Zolpidem 7. A total of patients in U. For a pool of U. Women clear Zolpidem tartrate from the body at a lower rate than men. Given the higher blood levels of Zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of Zolpidem tartrate tablets for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg.
In geriatric patients, clearance of Zolpidem is similar in men and women. The recommended dose of Zolpidem tartrate tablets in geriatric patients is 5 mg regardless of gender. 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: 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 was 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.
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. 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. 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. Zolpidem tartrate is a gamma-aminobutyric acid GABA A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. It has the following structure:.
Zolpidem tartrate is a white to almost white crystalline powder that is slightly soluble in water, sparingly soluble in methanol. It has a molecular weight of Each Zolpidem tartrate tablet includes the following inactive ingredients: 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.
This selective binding of Zolpidem on the BZ 1 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. In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg Zolpidem tartrate tablets, the mean peak concentrations C max were 59 range: The mean Zolpidem tartrate tablets elimination half-life was 2.
Zolpidem tartrate tablet is converted to inactive metabolites that are eliminated primarily by renal excretion. Zolpidem tartrate tablets demonstrated linear kinetics in the dose range of 5 to 20 mg. Total protein binding was found to be Zolpidem did not accumulate in young adults following nightly dosing with 20 mg Zolpidem tartrate tablets for 2 weeks. A food-effect study in 30 healthy male subjects compared the pharmacokinetics of Zolpidem tartrate tablets 10 mg when administered while fasting or 20 minutes after a meal.
The half-life remained unchanged. These results suggest that, for faster sleep onset, Zolpidem tartrate tablets should not be administered with or immediately after a meal. In the elderly, the dose for Zolpidem tartrate tablets should be 5 mg [see Warnings and Precautions 5 and Dosage and Administration 2 ]. Zolpidem tartrate tablets did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week. The pharmacokinetics of Zolpidem tartrate tablet in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects.
Following a single 20 mg oral Zolpidem tartrate dose, mean C max and AUC were found to be two times vs. T max did not change. The mean half-life in cirrhotic patients of 9. Dosing should be modified accordingly in patients with hepatic insufficiency [ see Dosage and Administration 2. No statistically significant differences were observed for C max , T max , half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made.
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. Similarly, chlorpromazine in combination with Zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration. Following five consecutive nightly doses at bedtime of oral Zolpidem tartrate 10 mg in the presence of sertraline 50 mg 17 consecutive daily doses, at 7: Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by Zolpidem.
A single-dose interaction study with Zolpidem tartrate 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. There was no evidence of an additive effect in psychomotor performance. The effect of inhibitors of other P enzymes on the pharmacokinetics of Zolpidem is unknown.
There were no pharmacodynamic effects of Zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance. Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects. In mice, these doses are approximately 2. No evidence of carcinogenic potential was observed in mice.
In rats, renal tumors lipoma, liposarcoma were seen at the mid- and high doses. Zolpidem was negative in in vitro bacterial reverse mutation, mouse lymphoma, and chromosomal aberration and in vivo mouse micronucleus genetic toxicology assays. There was no impairment of fertility at any dose tested. Both Zolpidem doses were superior to placebo on objective polysomnographic measures of sleep latency, sleep duration, and number of awakenings.
All Zolpidem doses were superior to placebo on the two primary PSG parameters sleep latency and efficiency and all four subjective outcome measures sleep duration, sleep latency, number of awakenings, and sleep quality. On objective polysomnographic measures of sleep latency and sleep efficiency, Zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4.
Zolpidem was comparable to placebo on number of awakenings at both doses studied. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week. Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with Zolpidem tartrate tablets.
Next-day residual effects of Zolpidem tartrate tablets were evaluated in seven studies involving normal subjects. In three studies in adults including one study in a phase advance model of transient insomnia and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test DSST when compared to placebo. There was no objective polysomnographic evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Zolpidem tartrate.
There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg. Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of Zolpidem tartrate tablets. However, in one study involving Zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect 90 minutes post-dose , i.
There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of Zolpidem tartrate tablets, predominantly at doses above 10 mg. Effects on sleep stages: In studies that measured the percentage of sleep time spent in each sleep stage, Zolpidem tartrate tablets has generally been shown to preserve sleep stages.
Sleep time spent in stages 3 and 4 deep sleep was found comparable to placebo with only inconsistent, minor changes in REM paradoxical sleep at the recommended dose. Zolpidem tartrate tablets 5 mg are pink, film coated, capsule shaped tablets, debossed with "W" on one side and plain on the other side:. Zolpidem tartrate tablets 10 mg are white, film coated, capsule shaped tablets, debossed with "W" on one side and plain on the other side:.
Inform patients and their families about the benefits and risks of treatment with Zolpidem tartrate tablets. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Zolpidem tartrate tablets and with each prescription refill.