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-aventisannounced today results from a new study that showed Ambien CR(R) (zolpidemtartrate extended-release) CIV tablets 12.5 mg provided significantimprovement in sleep onset, sleep maintenance and total sleep time over 8weeks in patients with co-morbid insomnia and major depressive disorder (MDD)who were administered a Selective Serotonin Reuptake Inhibitor (SSRI) fordepression. Ambien CR also improved sleep-related next-day functioningmeasures. This data was presented at the SLEEP 2008 22nd Annual Meeting of theAssociated Professional Sleep Societies (APSS).
Thomas Roth, PhD, director of the Sleep Disorders and Research Center atHenry Ford Hospital, states, 'The results of this study demonstrate thatAmbien CR can be considered a viable treatment option for the insomnia MDDpatients experience and help them get the good night's sleep they need toimprove their next-day functioning.'
Ambien CR Improved Sleep Quality and Sleep Impact on Daily Activities inMDD Patients
Total sleep time was increased in the Ambien CR group throughout thestudy. At Week eight, patients reporting sleeping an average of 101 minutesmore than baseline compared to placebo-treated patients who reported sleepingan average 64 minutes more (P<0.0001). On average, Ambien CR-treated patientsreported falling asleep sooner and exhibited improved sleep maintenance basedupon fewer nighttime awakenings and decreased wake time after sleep onsetcompared to placebo-treated patients (P<0.0001). In addition, patientsreported improvements in secondary measures related to daytime functioning,including morning energy, morning concentration and sleep impact on dailyactivities.
Treatment-emergent adverse events occurred in 72.9 percent of the patientstreated with Ambien CR and 66.3 percent of the patients treated with placebo.The most frequent adverse events experienced by Ambien CR and placebo wereheadache (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 CRand SSRIs and are known to be part of the safety profile of both treatments.
'Current therapies for MDD effectively treat depression symptoms, but maynot sufficiently address the sleep difficulties frequently associated with thedisorder, which are primarily difficulty falling asleep and staying asleep,'says Maurizio Fava, MD, Professor of Psychiatry at Harvard Medical School andExecutive Vice Chair of the Department of Psychiatry at Massachusetts GeneralHospital.
