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New Data Show Improvements in Work Performance in Patients with Chronic Insomnia Treated with AMBIEN CR(R) (zolpidem tartrate extended-release) Tablets CIV
Date:10/24/2007

Study Confirms Role of AMBIEN CR in Effectively Managing Insomnia to

Improve Quantity and Quality of Work Performance

BRIDGEWATER, N.J., Oct. 24 /PRNewswire-FirstCall/ -- Sanofi-aventis today announced results from a new study that showed patients with chronic insomnia who were treated with 12.5 mg of AMBIEN CR(R) (zolpidem tartrate extended- release) tablets CIV experienced significant improvements in two key parameters of work performance - output and time management - over a period of 12 weeks compared with patients taking placebo. Patients with chronic insomnia can have a higher frequency of work-related problems including absenteeism, an increased rate of accidents, difficulty performing duties and less job satisfaction. These results, which were part of a larger study that evaluated the efficacy and safety of AMBIEN CR when taken as needed, were recently presented at the 20th Annual U.S. Psychiatric and Mental Health Congress in Orlando, Florida.

The multi-center, phase IIIb, randomized, double-blind study included 728 patients with chronic primary insomnia (478 treated with AMBIEN CR and 250 treated with placebo). Treatment with AMBIEN CR showed significantly higher improvement from baseline in work tasks at week 12 in Work Limitation Questionnaire (WLQ) for both Time Management Scale (- 7.39 difference; p < 0.001) and the Output Scale (- 4.8 difference; p = 0.0076) compared to placebo, which was confirmed by an effect size analysis. The majority of adverse events experienced by patients in the study were mild to moderate in intensity, and the most frequently reported adverse events by participants include headache, anxiety and somnolence.

"These new data add to the growing body of evidence that shows that the treatment of chronic insomnia can improve next day functioning," said Milton Erman, MD, chief medical officer, Avastra USA, and clinical professor of psychiatry, UCSD School of Medicine. "This study demonstrates
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