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

IMPORTANT SAFETY INFORMATION

The recommended initial dose is 5 mg for women and either 5 or 10 mg for men. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness.

In elderly or debilitated patients, or patients with hepatic insufficiency, the recommended dose is 5 mg and patients should be closely monitored. Due to its rapid onset of action, patients should take AMBIEN right before going to bed and when ready for sleep. Patients should not take AMBIEN unless they are prepared to get a full night's sleep (7 to 8 hours) to avoid residual effects. Until they know how it will affect their physical or mental performance upon awakening, patients should not drive or operate hazardous machinery after taking AMBIEN or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, as well as abnormal behaviors such as being more outgoing or aggressive than normal, confusion, agitation, and hallucinations may occur. AMBIEN should not be taken with alcohol as it may increase these abnormal behaviors. Discontinuation of AMBIEN should be strongly considered for patients reporting such complex behaviors. Angioedema may occur in patients taking AMBIEN and in rare cases may be fatal. Patients who develop angioedema should not be rechallenged. In primarily depressed patients, worsening of depression, including risk of suicidal thoughts or actions, including completed suicides, have been reported. The most commonly observed adverse effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). Because individuals with a history of addiction or substance abuse are at increased risk of habituation and dependence, they should be under careful surveillance when receiving AMBIEN or any other hypnotic. AMBIEN is a Schedule IV controlled substance. Sedative hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. Hypnotics should generally be limited to 7 to 10 days of use, and reevaluation of the patient is recommended if they are taken for more than 2 to 3 weeks. Prescriptions for AMBIEN should not exceed a 1-month supply.

Please refer to the full prescribing information.