Indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.

Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg.

The total dose of AMBIEN should not exceed 10 mg once daily immediately before bedtime. AMBIEN should be taken as a single dose and should not be readministered during the same night. The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of AMBIEN in these patients is 5 mg once daily immediately before bedtime.

Because AMBIEN can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.

Long-term use of AMBIEN is not recommended. Treatment should be as short as possible. Extended treatment should not take place without re-evaluation of the patient’s status because the risk of abuse and dependence increases with the duration of treatment.

There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem.

Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of AMBIEN in these patients is 5 mg once daily immediately before bedtime. Avoid AMBIEN use in patients with severe hepatic impairment as it may contribute to encephalopathy.

AMBIEN is contraindicated in patients:

• who have experienced complex sleep behaviors after taking AMBIEN
• with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema

Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of AMBIEN. Patients can be seriously injured or injure others during complex sleep behaviors . Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with AMBIEN alone at recommended doses, with or without the concomitant use of alcohol or other Central Nervous System (CNS) depressants. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior.

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. Patients should be warned against driving and other activities requiring complete mental alertness if AMBIEN is taken in these circumstance.

The use of AMBIEN with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

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. 

Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including AMBIEN. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported.

Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including AMBIEN. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events. Amnesia, anxiety and other neuropsychiatric symptoms may also occur. 

Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if AMBIEN is prescribed to patients with compromised respiratory function or concomitant use with opioids or other CNS depressants. Postmarketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had preexisting 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 or with concomitant opioid use.

AMBIEN should be used with caution in patients with sleep apnea syndrome or myasthenia gravis.

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.

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.

AMBIEN, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of AMBIEN and of other concomitant CNS depressants may be necessary when AMBIEN is administered with such agents because of the potentially additive effect.

Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is not recommended.

Concomitant administration of zolpidem and sertraline increases exposure to zolpidem.

Use of St. 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.

Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation. Zolpidem has been shown to cross the placenta. Animal data: delayed fetal development (incomplete fetal skeletal ossification) and embryo-fetal death.

Limited data from published literature report the presence of zolpidem in human milk. There are reports of excess sedation in infants exposed to zolpidem through breastmilk.

GoToSource

• Use in patients under the age of 18. GoToSource

• Dosage greater than 10 mg once daily immediately before bedtime. GoToSource

• Brain damage. GoToSource

• Neuropsychiatric symptoms and motor dysfunction in parkinson’s disease. GoToSource

• Restless legs syndrome. GoToSource

• Adjunct treatment in anti-N-methyl-d-aspartate receptor encephalitis after tumor removal and immunotherapy. GoToSource

• Disorders of consciousness. GoToSource

• Post-stroke apathy. GoToSource

• Cerebellar mutism syndrome. GoToSource

• Sleep-disordered breathing. GoToSource

• Progressive supranuclear palsy. GoToSource

• Spinocerebellar ataxia. GoToSource

• Use with botulinum toxin type A injections for oromandibular (inferior lateral pterygoid muscle) dystonia. GoToSource

• Use with tamsulosin and zolpidem on nocturia in patients with benign prostatic hyperplasia. GoToSource

Sleepwalking, memory loss, confusion, hallucinations, suicidality and amnesia. GoToSource

Ischemic stroke. GoToSource

Hip fractures in patients over 50. GoToSource

Driving impairment. GoToSource

Sleep-related eating disorders. GoToSource

Rebound insomnia, abuse, dose escalation, dependency, withdrawal and increased risk of death. GoToSource

Increased risk of cancer. GoToSource

Fetal neural tube defects. GoToSource 

Urinary tract infection. GoToSource

Lawsuits filed for parasomnia, hallucinations, depression, suicidal thoughts and behaviors and addiction.