Moderate Monitor for an increase in sedation and other zolpidem-related adverse reactions if coadministration with palbociclib is necessary. Moderate CNS depressants should be combined cautiously with maprotiline because they could cause additive depressant effects and possible respiratory depression or hypotension. Precautions Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Alcohol or marijuana can make you more dizzy or drowsy. There is evidence of an increase in pharmacodynamic effects and systemic exposure of zolpidem during co-administration with some potent inhibitors of CYP3A4, such as azole antifungals. Reactions most commonly associated with discontinuation from U. Intermittent hemodialysis Zolpidem is not removed by hemodialysis.
Tell your doctor if you are breast-feeding a baby. It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol Haldol , a potent antipsychotic drug with dangerous side effects.
For more information, contact the U. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Zolpidem comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Never take Ambien , Edluar , or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again. Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.
Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice. Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.
Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem. Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water. Spray Zolpimist directly into your mouth over your tongue. Prime the spray before the first use by pumping 5 test sprays into the air, away from your face.
Prime the spray with 1 test spray if it has not been used for longer than 14 days. Store at room temperature away from moisture and heat. Keep the Zolpimist bottle upright when not in use. Seek emergency medical attention or call the Poison Help line at An overdose of zolpidem can be fatal when it is taken together with other medications that can cause drowsiness. Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia forgetfulness is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem. You may need a lower dose of zolpidem if you take other medicines that make you sleepy or slow your breathing such as cold medicine, pain medication, muscle relaxants, and medicine for depression, anxiety, or seizures.
Tell your doctor if you are currently taking any of these medications. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with zolpidem, especially:. This list is not complete. Other drugs may interact with zolpidem, including prescription and over-the-counter medicines, vitamins, and herbal products.
Not all possible interactions are listed in this medication guide. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. 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 table was derived from results of 11 placebo-controlled short-term U. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The following table was derived from results of three placebo-controlled long-term efficacy trials involving AMBIEN zolpidem tartrate. These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg.
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. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. 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 AMBIEN, 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: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Liver and biliary system: Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. Some compounds known to induce or inhibit CYP3A may affect exposure to zolpidem. The effect of drugs that induce or inhibit 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. Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of zolpidem. 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. Co-administration with other CNS depressants e. The risk of next-day psychomotor impairment, including impaired driving, is increased if AMBIEN is 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 the blood levels of zolpidem.
In order to minimize this risk a full night of sleep 7—8 hours is recommended. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. 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. 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. 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.