Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressiv... ( Ambien CR(R) 12.5 mg significantly i...)

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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

Ambien CR(R) 12.5 mg significantly improved sleep onset, sleep maintenance

and total sleep time compared to placebo

BRIDGEWATER, N.J., June 10 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today results from a new study that showed Ambien CR(R) (zolpidem tartrate extended-release) CIV tablets 12.5 mg provided significant improvement in sleep onset, sleep maintenance and total sleep time over 8 weeks in patients with co-morbid insomnia and major depressive disorder (MDD) who were administered a Selective Serotonin Reuptake Inhibitor (SSRI) for depression. Ambien CR also improved sleep-related next-day functioning measures. This data was presented at the SLEEP 2008 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS).

Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital, states, "The results of this study demonstrate that Ambien CR can be considered a viable treatment option for the insomnia MDD patients experience and help them get the good night's sleep they need to improve their next-day functioning."

Ambien CR Improved Sleep Quality and Sleep Impact on Daily Activities in MDD Patients

Total sleep time was increased in the Ambien CR group throughout the study. At Week eight, patients reporting sleeping an average of 101 minutes more than baseline compared to placebo-treated patients who reported sleeping an average 64 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). In addition, patients reported improvements in secondary measures related to daytime functioning, including morning energy, morning concentration and sleep impact on daily activities.

Treatment-emergent adverse events occurred in 72.9 percent of the patients treated wi
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