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Ambien CR(R) (zolpidem tartrate extended-release) tablets CIV Improved Chronic Insomnia in Patients with Co-Morbid Generalized Anxiety Disorder
Date:1/4/2008

BRIDGEWATER, N.J., Jan. 4 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today results from a new study that showed Ambien CR(R) (zolpidem tartrate extended-release) tablets CIV provided improvement in sleep onset, sleep maintenance and total sleep time for patients with co-morbid chronic insomnia and generalized anxiety disorder (GAD) compared to placebo. Ambien CR also improved sleep-related next-day functioning measures.

About the Study

This study was a multi-center, double-blind, parallel-group, randomized, placebo-controlled trial in 381 adults ages 21 to 64 with co-morbid chronic insomnia and GAD. The study evaluated the overall improvement of insomnia, as measured by total sleep time in patients treated with Ambien CR and the antidepressant escitalopram (Lexapro(R)) compared to treatment with placebo and escitalopram. Patients received Ambien CR 12.5 mg (n=191) or placebo (n=190) each night followed by 10 mg of escitalopram each day during the 8-week study, followed by a one-week period of escitalopram only. Treatment was well tolerated during the study and adverse events were similar between treatment groups.

"The anxiety experienced by patients with GAD can often lead to sleep problems such as difficulty falling asleep or staying asleep," says Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital. "Data from this study show that Ambien CR can be considered a treatment option for the insomnia in GAD to help them get the full night's sleep they need to maintain their next-day functioning."

Researchers assessed treatment efficacy during clinic visits at Weeks 1, 2, 4, 6 and 8 and through daily patient-reported Morning Sleep Questionnaires (MSQ). The MSQ measured the primary efficacy outcome of total sleep time in addition to measurements of sleep onset latency, wake time after sleep onset, number of awakenings, quality of sleep and sleep-related next-day functioning.

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SOURCE sanofi-aventis
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