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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

Improved Sleep Quality and Sleep Impact on Daily Activities in GAD Patients

Total sleep time was increased in the Ambien CR group throughout the study. At Week 8, patients reporting sleeping an average of 106 minutes more than baseline compared to placebo-treated patients who reported sleeping an average 68 minutes more (P<0.0001). On average, Ambien CR-treated patients reported falling asleep sooner and exhibited improved sleep maintenance based upon fewer nighttime awakenings and decreased wake time after sleep onset compared to placebo-treated patients (P<0.0001). At Week 8, the number of nighttime awakenings decreased in the Ambien CR/escitalopram group (-1.33 + or - 1.26) compared to the placebo/escitalopram group (-0.76 + or - 1.02), and time to sleep onset was reduced 55.1 (+ or - 67.3) minutes with Ambien CR compared to a reduction of 26.8 (+ or - 58.7) minutes with placebo (P<0.0001). In addition, patients reported improvements in secondary measures relating to daytime functioning, including morning energy, morning concentration and sleep impact on daily activities.

Adverse events occurred in 76% of patients treated with Ambien CR/escitalopram and 71% of the patients treated with placebo/escitalopram. The most frequent adverse events experienced by both treatment groups were nausea, dizziness and fatigue. These adverse events have been reported in previous studies of both Ambien CR and escitalopram and are known to be part of the safety profile of both treatments. One patient in each treatment group experienced different serious adverse events.

About Insomnia

Insomnia can be a serious medical condition characterized by difficulty falling asleep, difficulty staying asleep (waking up often during the night and having trouble going back to sleep), waking up too early in the morning and feeling tired upon waking. About 10% of Americans are affected by chronic insomnia each year.

Patients with chronic insomnia report higher ra
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SOURCE sanofi-aventis
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