Evaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia.

Objective: To assess patient-reported efficacy and safety of ramelteon in Japanese patients with chronic insomnia.

Methods: Randomized, double-blind, placebo-controlled, multicenter trial. After a placebo lead-in period, 987 adults with chronic insomnia received ramelteon 8 mg or placebo once daily for 2 weeks, followed by a placebo run-out period to monitor rebound insomnia. Patient-reported sleep data were collected using sleep diaries.

Results: Ramelteon significantly reduced mean patient-reported sleep latency (primary endpoint) compared with placebo during week 1 (-4.54 min; p=0.001). Ramelteon maintained greater efficacy in sleep latency than placebo at week 2, but the difference did not achieve statistical significance. In a subset of patients who adhered to treatment and completed their diaries as instructed, a statistically significant reduction in subjective sleep latency was sustained through week 2. Compared with placebo, ramelteon also significantly improved mean total sleep time and mean sleep quality during week 1, the number of awakenings during week 2, and overall patient global impression scores. There was no evidence of rebound insomnia. Adverse events were generally mild and transient.

Conclusions: In Japanese adults with chronic insomnia, ramelteon 8 mg significantly reduced patient-reported sleep latency, increased total sleep time and improved sleep quality after 1 week of treatment. Ramelteon was generally well tolerated with no rebound insomnia.