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To assess patient-reported efficacy and safety of ramelteon in Japanese patients with chronic insomnia.Randomized, double-blind, placebo-controlled, multicenter trial. After a placebo lead-in period, 987 adults with chronic insomnia received ramelteon 8mg or placebo once daily for 2weeks, followed by a placebo run-out period to monitor rebound insomnia. Patient-reported sleep data were collected using...
To evaluate the safety of ramelteon, a highly selective MT 1 /MT 2 melatonin receptor agonist, during 24weeks’ treatment of Japanese patients with chronic insomnia.In a single-blind, flexible-titration, multicenter study incorporating placebo run-in and run-out periods, 190 adults with chronic insomnia received ramelteon 4 or 8mg, titrated up to 16mg if necessary, for 24weeks. Primary...
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