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Ramelteon Provides Sleep Aid for Chronic Insomniacs: Presented at APA By Carole Bullock WASHINGTON, DC -- May 14, 2008 -- Ramelteon, a melatonin agonist, reduced time to sleep onset by about 13 minutes compared with placebo in a pooled analysis of randomized studies, researchers reported here at the 161st Annual Meeting of the American Psychiatric Associations (APA). "Several previous clinical studies have demonstrated the ability of ramelteon to decrease time to sleep onset, and this pooled analysis shows it reduced latency to persistent sleep," Louis Mini, MD, Senior Medical Director, Neuroscience, Medical and Science Affairs, Takeda Global Research and Development Center, Deerfield, Illinois, reported in a poster session May 8. "Up until that we had individual studies on sleep effect, and the new study puts this in context," Dr. Mini said in an interview. The current study was a pooled analysis of 4 randomized, double-blind, placebo-controlled clinical trials of ramelteon in subjects with chronic insomnia. The studies in the analysis were all designed specifically to assess the sleep-promoting effect of ramelteon in adults aged 18 to 83 years diagnosed with chronic insomnia, said Dr. Mini. All trials had a primary endpoint of reduced latency to persistent sleep (LPS) measured by polysomnography at nights 1 and 2. The pooled analysis included a total of 566 subjects who took ramelteon 8 mg daily and 556 subjects who took placebo. Baseline mean LPS was 66.6 minutes for the placebo group and 66.9 minutes for the ramelteon 8-mg group. At nights 1 and 2, mean LPS for the ramelteon 8-mg group was significantly less than for the placebo group (30.2 vs 43.3 min). The LPS mean difference was -13.1 minutes in favor of ramelteon (P < .001), according to the researchers. Chronic insomnia affects about 10% adults, and approved therapies are limited to the benzodiazepines, nonbenzodiazepines, and receptor agonists, according to the researchers. "Ramelteon is the only melatonin agonist approved for treatment of insomnia and several clinical studies showed that it decreased mean LPS in chronic insomnia, and this pooling of studies add more weight to the data," Dr. Mini said in an interview. Funding for this study was provided by Takeda Pharmaceuticals Company, Ltd. [Presentation title: Ramelteon Pooled Analysis: Effects of Ramelteon 8 mg on Objective Sleep Latency at Nights 1 and 2. Abstract NR6-092] E-mail this page to a friend or colleague! To print, use this version