Overdose[ edit ] An overdose of zolpidem may cause excessive sedation, pin-point pupils, or depressed respiratory function, which may progress to coma, and possibly death. Combined with alcohol, opiates, or other CNS depressants, it may be even more likely to lead to fatal overdoses.

Zolpidem overdosage can be treated with the benzodiazepine receptor antagonist flumazenil , which displaces zolpidem from its binding site on the benzodiazepine receptor to rapidly reverse the effects of the zolpidem.

Analytical techniques, in general, involve gas or liquid chromatography. This adverse effect is not unique to zolpidem but also occurs with other hypnotic drugs. Caution should be exercised by motor vehicle drivers.

As a consequence, the FDA recommended the dose for women be reduced and that prescribers should consider lower doses for men. Zolpidem causes an increased risk of falls and may induce adverse cognitive effects. Compared with the benzodiazepines, the nonbenzodiazepine including zolpidem sedative-hypnotics appeared to offer few, if any, significant clinical advantages in efficacy or tolerability in elderly persons. Newer agents with novel mechanisms of action and improved safety profiles, such as the melatonin receptor agonists , were found to hold promise for the management of chronic insomnia in elderly people.

Long-term use of sedative-hypnotics for insomnia lacks an evidence base and has traditionally been discouraged for reasons that include concerns about such potential adverse drug effects as cognitive impairment anterograde amnesia , daytime sedation, motor incoordination, and increased risk of motor vehicle accidents and falls.

In addition, the effectiveness and safety of long-term use of these agents remain to be determined. More research is needed to evaluate the long-term effects of treatment and the most appropriate management strategy for elderly persons with chronic insomnia. The same trend was found for reflux events in patients without GERD. This is assumed to be due to suppression of arousal during the reflux event, which would normally result in a swallowing reflex to clear gastric acid from the esophagus.

Patients with GERD experience significantly higher esophageal exposure to gastric acid, which increases the likelihood of their developing esophageal cancer. 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.

Some of these changes included decreased inhibition e. Visual and auditory hallucinations have been reported. Complex behaviors such as "sleep-driving" i. Due to the risk to the patient and the community, discontinuation of AMBIEN should be strongly considered for patients who report a "sleep-driving" episode.

Other complex behaviors e. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuropsychiatric symptoms may also occur.

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.

Use In Patients With Depression In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions including completed suicides , have been reported.

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 lowest number of tablets that is feasible should be prescribed for the patient at any one time. Since sedativehypnotics have the capacity to depress respiratory drive, precautions should be taken if AMBIEN is prescribed to patients with compromised respiratory function.

Post-marketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had pre-existing respiratory impairment, have been reported. The risk of respiratory depression should be considered prior to prescribing AMBIEN in patients with respiratory impairment including sleep apnea and myasthenia gravis. Precipitation Of Hepatic Encephalopathy GABA agonists such as zolpidem tartrate have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency.

In addition, patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function. Withdrawal Effects There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem.

Monitor patients for tolerance, abuse, and dependence [see Drug Abuse And Dependence ]. Severe Injuries Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. 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. 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. Zolpidem Description 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 - 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. 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.

In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg Zolpidem tartrate tablets, the mean peak concentrations Cmax 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.

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