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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

that AMBIEN CR is not only an effective treatment option to help patients with chronic insomnia fall and stay asleep, but is also associated with significant improvements in work performance. In that the performance improvements were correlated with the clinical improvements, this analysis demonstrated that AMBIEN CR-treated patients did better at work because their sleep improved."

About the Study

Treatments were administered from three to seven nights a week during a six-month period. Work outcomes were measured by the Work Limitation Questionnaire (WLQ), a self-administrated questionnaire measuring the degree to which health problems interfere with the ability to perform job roles. Patients were asked to rate their level of performance on 25 specific job demands by assigning scores ranging from 0 (limitations none of the time) to 100 (limitations all of the time). WLQ outcomes were assessed at baseline, week 4, 12, and end of treatment (week 24) or premature discontinuation. Two of the WLQ scales were included in the study: worker output and time management. Worker output assessed the ability to meet demands for quantity and quality of work while completing tasks in a timely manner. Time management assessed the ability to meet time demands and cope with scheduling pressures.

Study Results

In patients treated with AMBIEN CR, mean output scores improved by 14.1 points compared to 9.3 points for placebo. Mean time management scores improved by 17.8 points for AMBIEN CR-treated patients compared to 8.6 points for placebo. While both AMBIEN CR and placebo decreased work output and time management scores between baseline and week 12, the changes were significantly higher in AMBIEN CR compared to placebo. Performance improvements were clinically valid, as improvements in the WLQ scores for AMBIEN CR-treated patients were correlated with improvements in subjective scores from the same patients.

Safety analyses, conducted in patients who too
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SOURCE sanofi-aventis
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