However, get medical help right away if you notice any symptoms of a serious allergic reaction , including: Moderate Moderately clinically significant. Infants born to mothers who have used sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. Tell patients that AMBIEN has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. When this medication is used for a long time, it may not work as well. Before using this medication , tell your doctor or pharmacist your medical history, especially of: This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. 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.
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. 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 ].
Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. Severe injuries such as hip fractures and intracranial hemorrhage have been reported. Tell patients that AMBIEN has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed.
Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior change, including "sleep driving" and other complex behaviors while not being fully awake preparing and eating food, making phone calls, or having sex.
Tell patients to call you immediately if they develop any of these symptoms. Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Tell patients not to increase the dose of AMBIEN on their own, and to inform you if they believe the drug "does not work". Patients should be counseled to take AMBIEN right before they get into bed and only when they are able to stay in bed a full night 7—8 hours before being active again.
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. 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 sedativehypnotic drugs during pregnancy. AMBIEN should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Zolpidem is excreted in human milk. 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 AMBIEN 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 AMBIEN in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime. General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. 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, 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 BZ 1 receptor preferentially with a high affinity ratio of the a subunits. 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 Cmax were 59 range: 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 AMBIEN 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, AMBIEN should not be administered with or immediately after a meal. The pharmacokinetics of AMBIEN 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 vs. Tmax did not change. The mean half-life in cirrhotic patients of 9. 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.
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.
Some compounds known to inhibit CYP3A may increase exposure to zolpidem. 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. 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 AMBIEN.
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 AMBIEN 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 AMBIEN. 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 AMBIEN, predominantly at doses above 10 mg. In studies that measured the percentage of sleep time spent in each sleep stage, AMBIEN 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.
There may be new information. Do not take more than Women are usually prescribed a lower dose because the drug is removed from the body more slowly than in men. Older adults are usually prescribed a lower dose to decrease the risk of side effects. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms such as nausea , vomiting , flushing, stomach cramps , nervousness, shakiness may occur if you suddenly stop using this medication.
To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Though it helps many people, this medication may sometimes cause addiction. Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after nights. If this effect continues, contact your doctor. If this effect persists or worsens, tell your doctor or pharmacist promptly. This medication may make you sleepy during the day.
Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake " sleep -driving".
Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction , including: This is not a complete list of possible side effects.
If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication , tell your doctor or pharmacist your medical history, especially of: Do not drive, use machinery, or do any activities that require clear thinking after you take this medication and the next day. You may feel alert, but this medication may continue to affect your thinking, making such activities unsafe.
This medication may also increase the risk of falls. Alcohol or marijuana can make you more dizzy or drowsy. Do not drink alcoholic beverages. Talk to your doctor if you are using marijuana. Children may be more sensitive to the side effects of this drug, especially dizziness and hallucinations. Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling.
Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs , nonprescription drugs, and herbal products. During pregnancy , this medication should be used only when clearly needed. Infants born to mothers who have taken sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. Discuss the risks and benefits with your doctor.
A small amount of this medication passes into breast milk. Consult your doctor before breast -feeding. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.