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Thank you for your interest in Ambien

The FDA has asked that a Medication Guide be distributed with each prescription dispensed for all prescription hypnotic drugs indicated for insomnia.

We offer three convenient ways to obtain Ambien Medication Guides:

Patients should read the Medication Guide before taking Ambien and each time they get a refill. There may be new information.

Indications

AMBIEN is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

AMBIEN CR (zolpidem tartrate) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

AMBIEN and AMBIEN CR are not recommended in children under the age of 18 years.

Important Safety Information for AMBIEN and AMBIEN CR

Dosage and Administration

Use the lowest effective dose.

The recommended initial dose of AMBIEN is 5 mg for women and either 5 or 10 mg for men.

The recommended initial dose of AMBIEN CR is 6.25 mg for women and either 6.25 or 12.5 mg for men.

The total dose of AMBIEN should not exceed 10 mg and AMBIEN CR should not exceed 12.5 mg.

Due to its rapid onset of action, patients should take AMBIEN or AMBIEN CR immediately before bedtime, once per night, with at least 7-8 hours remaining before the planned time of awakening.

In elderly or debilitated patients, or patients with hepatic insufficiency, the recommended dose of AMBIEN is 5mg or AMBIEN CR is 6.25 mg. Avoid AMBIEN or AMBIEN CR use in patients with severe hepatic impairment as it may contribute to encephalopathy.

Dosage adjustment may be necessary when AMBIEN or AMBIEN CR is combined with other CNS-depressant drugs.

Warnings and Precautions

Ambien and Ambien CR are central nervous system (CNS) depressants. Additive effects occur with concomitant use of other CNS depressants (e.g. benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use.

The risk of next-day psychomotor impairment, including impaired driving, is increased if AMBIEN or AMBIEN CR 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.

Symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Angioedema and anaphylaxis may occur in patients taking AMBIEN or AMBIEN CR and in rare cases may be fatal. Patients who develop angioedema and anaphylaxis should not be rechallenged.

Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including AMBIEN and AMBIEN CR. 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.

“Sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) and other complex behaviors have been reported. The co-administration of alcohol and other CNS depressants increases the risk of such behaviors, as does the use of AMBIEN or AMBIEN CR at doses exceeding the maximum recommended dose. Discontinuation of AMBIEN or AMBIEN CR should be strongly considered for patients who report a “sleep-driving” episode.

In primarily depressed patients, worsening of depression, including risk of suicidal thoughts or actions, including completed suicides, have been reported. The lowest number of tablets feasible should be prescribed to avoid intentional overdose.

The risk of respiratory depression should be considered in patients with respiratory impairment including sleep apnea and myasthenia gravis.

AMBIEN and AMBIEN CR can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries.

Adverse Reactions

The most commonly observed adverse effects in controlled clinical trials for AMBIEN were drowsiness, dizziness, and diarrhea during short term treatment (up to 10 nights) and dizziness and drugged feelings during longer-term treatment (28 to 35 nights).

The most commonly observed adverse effects in controlled clinical trials for AMBIEN CR were headache, next-day somnolence and dizziness.

Drug Abuse and Dependence

AMBIEN and AMBIEN CR are Schedule IV controlled substances.

Because persons with a history of addiction or substance abuse are at increased risk for misuse, abuse and addiction of AMBIEN or AMBIEN CR, they should be monitored carefully when receiving AMBIEN or AMBIEN CR.

Sedative hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation.

Click here for full Prescribing Information including the Medication Guide for AMBIEN. Click here for full Prescribing Information including the Medication Guide for AMBIEN CR.