Zolpidem is excreted in human milk. Comment about this article, ask questions, or add new information about this topic: Journal of Addictive Diseases. Retrieved 3 April In mice, these doses are approximately 2. Ambien (zolpidem): Dosing and Common Side 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. 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. The extended-release form of zolpidem is Ambien CR , which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep. Ambien , Edluar , and Zolpimist are used to help you fall asleep when you first go to bed.
Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping. Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: 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. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before. Do not share this medication with another person , even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.
Misuse of this medication can result in dangerous side effects. Zolpidem may impair your thinking or reactions. 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 at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder. You should not use this medication if you are allergic to zolpidem. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.
Zolpidem may be habit forming and should be used only by the person it was prescribed for. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Zolpidem can pass into breast milk and may harm a nursing baby.
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.