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Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder
Date:6/10/2008

th Ambien CR and 66.3 percent of the patients treated with placebo. The most frequent adverse events experienced by Ambien CR and placebo were headache (14.1 percent; 17.9 percent) and nausea (10.9 percent; 8.4 percent). These adverse events have been reported in previous studies of both Ambien CR and SSRIs and are known to be part of the safety profile of both treatments.

"Current therapies for MDD effectively treat depression symptoms, but may not sufficiently address the sleep difficulties frequently associated with the disorder, which are primarily difficulty falling asleep and staying asleep," says Maurizio Fava, MD, Professor of Psychiatry at Harvard Medical School and Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital. "The extended release formulation of zolpidem tartrate was found to be an effective adjunctive treatment option that helped patients fall asleep and stay asleep in this study, but may also have a positive effect on some secondary symptoms such as fatigue and lack of motivation."

Similar improvements in sleep onset, maintenance and total sleep time and related next-day function were also demonstrated in an earlier study of Ambien CR in patients with insomnia and co-morbid general anxiety disorder (GAD). It was the third largest, recently-completed clinical study of Ambien CR that demonstrated improved measurements of next-day function as related to improving sleep induction and sleep maintenance symptoms of insomnia.

About the Study

This was a multi-center, double-blind, parallel-group, randomized, placebo controlled study in 383 adults ages 21 to 64 with co-morbid insomnia and MDD. The study evaluated the overall improvement of insomnia, as measured by total sleep time and in patients treated with Ambien CR and the antidepressant escitalopram (Lexapro(R)) 10 mg compared to treatment with placebo and escitalopram. Patients received Ambien CR 12.5 mg (n=193) or placebo (n=192) each n
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