AMBIEN CR Sleep Maintenance

Helps Patients Fall Asleep Quickly

AMBIEN CR significantly reduced latency to persistent sleep (LPS) vs. placebo as measured using polysomnography (PSG) from baseline to Nights 1/2 and Nights 15/16.^2*†

Reduces the Number of Awakenings

In a traffic noise model of insomnia, AMBIEN CR significantly reduced number of awakenings vs. zolpidem tartrate and placebo in healthy subjects.²

Reducing the Time Spent Awake During the Night

AMBIEN CR provides sleep maintenance by significantly reducing wake-time after sleep onset (WASO)^§‡ vs. placebo as measured using PSG from baseline at Nights 1/2. AMBIEN CR was not significantly different from placebo at Nights 15/16.^2*||
AMBIEN CR 12.5 mg decreased WASO for the first 7 hours during the first 2 nights and for the first 5 hours after 2 weeks of treatment.¹
In both studies, in patients treated with AMBIEN CR, PSG showed increased wakefulness at the end of the night compared to placebo.¹

Sleep maintenance differed in elderly patients.

* Results of a randomized, double-blind, parallel-group, 3-week trial of adult outpatients (N=212) with primary insomnia. Study compared AMBIEN CR 12.5 mg and placebo using PSG and subjective assessments.²

† Nights 1/2 (P<0.0001), Nights 15/16 (P=0.0338).

‡ (P<0.0001).

§ WASO measured for hours 1-8.

|| Nights 1/2 (P<0.0001), Nights 15/16 (P=0.1913).

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.
2 Data on file, sanofi-aventis.