Controlled Trials¹

Adults aged 18-64 years with primary insomnia (N=212) were evaluated in a double-blind, randomized, parallel-group, 3-week trial comparing AMBIEN CR 12.5 mg and placebo. AMBIEN CR 12.5 mg decreased Wake-time After Sleep Onset (WASO) for the first 7 hours during the first 2 nights and for the first 5 hours after 2 weeks of treatment. AMBIEN CR 12.5 mg was superior to placebo on objective measures (polysomnography [PSG] recordings) of sleep induction (by decreasing Latency to Persistent Sleep [LPS]) during the first 2 nights of treatment and after 2 weeks of treatment. AMBIEN CR 12.5 mg was also superior to placebo on the patient-reported global impression regarding the aid to sleep, after the first 2 nights and for up to 3 weeks of treatment.

Elderly adults aged 65 years or older with primary insomnia (N=205) were evaluated in a double-blind, randomized, parallel-group, 3-week trial comparing AMBIEN CR 6.25 mg and placebo. AMBIEN CR 6.25 mg decreased WASO for the first 6 hours during the first 2 nights, and the first 4 hours after 2 weeks of treatment. AMBIEN CR 6.25 mg was superior to placebo on objective measures (PSG recordings) of sleep induction (by decreasing LPS) during the first 2 nights of treatment and after 2 weeks on treatment. AMBIEN CR 6.25 mg was superior to placebo on the patient-reported global impression regarding the aid to sleep, after the first 2 nights and after 3 weeks of treatment. In both studies, in patients treated with AMBIEN CR, PSG showed increased wakefulness at the end of the night compared to placebo-treated patients.

Important safety information:

AMBIEN CR is indicated for the treatment of insomnia.

In elderly or debilitated patients, or patients with hepatic insufficiency, the recommended dose is 6.25 mg and patients should be closely monitored. Due to its rapid onset of action, patients should take AMBIEN CR right before going to bed and when ready for sleep.

Patients should not take AMBIEN CR 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 CR or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, have been reported in patients who have taken a sedative hypnotic. Discontinuation of AMBIEN CR should be strongly considered for patients reporting such complex behaviors. Rare cases of angioedema have been reported in patients after taking sedative hypnotics. Patients who develop angioedema should not be rechallenged. The most commonly observed adverse effects in controlled clinical trials were headache, somnolence, and dizziness. 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 CR or any o ther hypnotic. AMBIEN CR is a Schedule IV controlled substance. US clinical trial experience from zolpidem does not reveal any clear evidence for withdrawal syndrome.

Please refer to the full prescribing information.

References:

1 AMBIEN CR Prescribing Information.

Controlled Trials1

References:

Controlled Trials¹