Sanofi-aventis (Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) today announced results from a study that demonstrated AMBIEN CR is well-tolerated and effective in improving sleep onset and maintenance for up to six months in patients with chronic primary insomnia when taken as needed for up to seven nights per week, without rebound insomnia following discontinuation. These data are being presented on July 12 in Chicago at the CINP (Collegium Internationale Neuro- Psychopharmacologicum) 25th Biennial Congress, a meeting ground for clinicians and scientists to report new scientific evidence in biochemistry, pharmacology, safety, and therapeutic efficacy of neuropsychiatric drugs.
According to the data, AMBIEN CR demonstrated significant improvements in total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset (WASO), sleep quality, and number of awakenings versus placebo. AMBIEN CR is the first and only controlled release prescription sleep medicine approved by the FDA for sleep induction and sleep maintenance.
"These data are important for patients who experience chronic insomnia because they demonstrate there is a treatment option in AMBIEN CR that can be taken safely and effectively as needed long-term to help them both fall asleep and maintain sleep through the night," said Tom Roth, PhD, director, Sleep Disorders Center, Henry Ford Hospital.
About the Study
This multicenter, double-blind, placebo-controlled evaluation of AMBIEN CR 12.5mg involved 1,018 adult volunteers who were studied for a period of 25 weeks. The objective of this study was to evaluate the long-term safety and efficacy of AMBIEN CR taken as needed up to 7 nights per week. Efficacy was assessed by Patient Global Impression (PGI) and Clinical Global Impression (CGI) scales every 4th week and daily morning questionnaires. The PGI scale requires patients to rate how much their condition has improved or worsened relative to baseline. The Clinical Global Impression (CGI) scale requires the clinician to rate how much the patient's condition has improved or worsened relative to baseline. The primary endpoint of the study was the 12-week PGI aid to sleep. Rebound insomnia was evaluated the first three nights after treatment discontinuation at the end of the study.
In PGI measurements for the AMBIEN CR group at weeks 12 and 24, 89.8% and 92.3% of patients reported that treatment helped them sleep versus 51.4% and 59.7% of patients in the placebo group. From score analysis, AMBIEN CR significantly improved PGI versus placebo at each 4-week interval of the 24- week treatment period (P<.0001, all time points). By CGI, the percentage of patients who reported "much or very much improved" was significantly greater at each 4-week interval of the treatment period (P<.0001, all time points) in the AMBIEN CR group (week 12: 75.0%; week 24: 84.3%) compared with the placebo group, respectively (week 12: 37.1%; week 24: 48.1%). No worsening of TST or WASO, versus baseline, occurred following discontinuation. AMBIEN CR tablet intake was stable across six months (mean treatment days/month across months: range 18.9-20.1).