You should not use this medicine if you are allergic to zolpidem. No evidence of carcinogenic potential was observed in mice. In mice, these doses are approximately 2, 9, and 40 times the maximum recommended human dose MRHD of Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again. In a 6-month study in adult patients 18—64 years of age , 8. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur. Zolpidem Tartrate 5mg
Patients should be warned against driving and other activities requiring complete mental alertness if Zolpidem Tartrate Extended-Release Tablets is taken in these circumstances [see Dosage and Administration 2 and Clinical Studies 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. Although behaviors such as "sleep-driving" have occurred with Zolpidem Tartrate Extended-Release Tablets alone at therapeutic doses, the co-administration of alcohol and other CNS depressants increases the risk of such behaviors, as does the use of Zolpidem Tartrate Extended-Release Tablets at doses exceeding the maximum recommended dose.
Due to the risk to the patient and the community, discontinuation of Zolpidem Tartrate Extended-Release Tablets 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 neuro-psychiatric 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 sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if Zolpidem Tartrate Extended-Release Tablets are 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 Zolpidem Tartrate Extended-Release Tablets in patients with respiratory impairment including sleep apnea and myasthenia gravis. In addition, patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function. Avoid Zolpidem Tartrate Extended-Release Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration 2.
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 9. 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. The following serious adverse reactions are discussed in greater detail in other sections of the labeling:.
Associated with discontinuation of treatment: In a 6-month study in adult patients 18—64 years of age , 8. Reactions most commonly associated with discontinuation of Zolpidem Tartrate Extended-Release Tablets included anxiety anxiety, restlessness or agitation reported in 1. Most commonly observed adverse reactions in controlled trials: During treatment with Zolpidem Tartrate Extended-Release Tablets in adults and elderly at daily doses of 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 Zolpidem Tartrate Extended-Release Tablets. These trials involved patients with primary insomnia who were treated for 3 weeks with Zolpidem Tartrate Extended-Release Tablets at doses of 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.
Other adverse reactions observed during the premarketing evaluation of Zolpidem Tartrate Extended-Release Tablets: Immediate-release zolpidem tartrate was administered to 3, subjects in clinical trials throughout the U. 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 Zolpidem Tartrate, 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: The following adverse reactions have been identified during post-approval use of Zolpidem Tartrate Extended-Release Tablets.
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. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions 5.
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 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.
Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is not recommended [see Clinical Pharmacology John's wort, a CYP3A4 inducer, in combination with zolpidem may decrease blood levels of zolpidem and is not recommended. Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4 inhibitor and zolpidem are given together [see Clinical Pharmacology There are no adequate and well-controlled studies of Zolpidem Tartrate Extended-Release 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 Extended-Release Tablets should be used during pregnancy only if the potential benefit outweighs 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 Zolpidem Tartrate Extended-Release Tablets maximum recommended human dose MRHD of Zolpidem Tartrate Extended-Release Tablets have no established use in labor and delivery [see Pregnancy 8. Zolpidem is excreted in human milk.
Caution should be exercised when Zolpidem Tartrate Extended-Release Tablets are administered to a nursing woman. Zolpidem Tartrate Extended-Release 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. FDA has not required pediatric studies of Zolpidem Tartrate Extended-Release Tablets in the pediatric population based on these efficacy and safety findings.
Women clear zolpidem tartrate from the body at a lower rate than men. Between 6 and 12 hours after dosing, zolpidem concentrations were 2- to 3 fold higher in adult female compared to adult male subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of Zolpidem Tartrate Extended-Release Tablets for adult women is 6.
In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of Zolpidem Tartrate Extended-Release Tablets in patients with mild to moderate hepatic impairment is 6. 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 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.
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 Extended-Release Tablets are available in 6. 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 Zolpidem Tartrate Extended-Release Tablet consists of a coated two-layer tablet: 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.
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 this 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 medicine. 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. Dosage Information in more detail. Seek emergency medical attention or call the Poison Help line at An overdose of zolpidem can be fatal, especially 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. You may still feel sleepy the morning after taking zolpidem, especially if you take the extended-release tablet, or if you are a woman.
Wait 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 medicine have worn off. Amnesia forgetfulness is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem. Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to zolpidem: Report any new or worsening symptoms to your doctor, such as: This is not a complete list of side effects and others may occur.
Call your doctor for medical advice about side effects. Side effects in more detail. Use the lowest dose possible to minimize the risk of next day impairment of activities that require full alertness. For the short-term treatment of insomnia characterized by difficulties with sleep initiation: For use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep if the patient has at least 4 hours of bedtime remaining before the planned time of waking: Recommended and maximum dose: Place under the tongue and allow to disintegrate completely before swallowing.
The tablet should not be swallowed whole and not administered with or immediately after a meal. Men and women over 65 years of age: Taking zolpidem with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures. Many drugs can interact with zolpidem, making it less effective or increasing side effects.
This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with zolpidem. Give a list of all your medicines to any healthcare provider who treats you. Insomnia melatonin , lorazepam , amitriptyline , Ambien , Ativan , diphenhydramine , temazepam , doxepin , Elavil , Restoril , Lunesta , Ibuprofen PM , eszopiclone , Belsomra , Rozerem , triazolam , zaleplon , ramelteon , Sonata , doxylamine , Halcion , Silenor , flurazepam , estazolam , More The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
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