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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

ight and 10 mg of escitalopram each day during the 24-week study.

Researchers assessed treatment efficacy through daily patient-reported Morning Sleep Questionnaires (MSQ) and during bi-weekly visits for eight weeks and every fourth week if the patients (depression responders) were part of an additional 16-week treatment period. The MSQ measured the primary efficacy outcome of total sleep time in addition to secondary measurements of sleep onset latency, wake time after sleep onset, number of awakenings, quality of sleep and sleep-related next-day functioning.

About Insomnia

Insomnia -- difficulty falling asleep, staying asleep or waking too early and not being able to get back to sleep - is one of the most common sleep problems. Approximately 50 to 70 million Americans are affected by insomnia each year, which can lead to a range of overall health and medical implications.

About Ambien CR(R) (zolpidem tartrate extended-release) CIV tablets

Ambien CR is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). Ambien CR is not indicated for the treatment of MDD or GAD.

Important Safety Information

Ambien CR is indicated for the treatment of insomnia. Ambien CR is not indicated for the treatment of MDD or GAD. Due to its rapid onset of action, patients should take Ambien CR right before going to bed and when ready for sleep. Patients should not take Ambien CR unless they are prepared to get a full night's sleep (7 to 8 hours) to avoid residual effects. Until they know how it will affect their physical or mental performance upon awakening, patients should not drive or operate hazardous machinery after taking Ambien Cr or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, have been reported in patients who have taken a sedative
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SOURCE sanofi-aventis
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