Sleep Maintenance in Elderly Patients

Helps patients age 65 and older 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.^1*†

Provides sleep maintenance by reducing time spent awake during the night.

AMBIEN CR significantly increased sleep duration by reducing Wake-time After Sleep Onset (WASO)^‡ vs. placebo as measured using PSG from baseline to Nights 1/2 and Nights 15/16.^1*§
AMBIEN CR decreased WASO for the first 6 hours during the first 2 nights and for the first 4 hours after 2 weeks of treatment.²
In both studies, in patients treated with AMBIEN CR, PSG showed increased wakefulness at the end of the night compared to placebo.²

Elderly patients spent more time in bed asleep.

AMBIEN CR significantly improved sleep efficiency vs. placebo as measured using PSG from baseline to Nights 1/2.^*|| AMBIEN CR was not significantly different from placebo at Nights 15/16.¹

* Results of a double-blind, randomized, placebo-controlled, parallel-group study comparing AMBIEN CR 6.25 mg vs. placebo using PSG and subjective assessments in 205 elderly patients with primary insomnia.¹

†Nights 1/2 (P=0.0001), Nights 15/16 (P=0.0255).

‡WASO measured for hours 1-6.

§Nights 1/2 (P<0.0001), Nights 15/16 (P=0.0042).

||Nights 1/2 (P<0.0001), Nights 15/16 (P=0.0509).

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 data on file, sanofi-aventis.
2 AMBIEN CR Prescribing Information.