Evaluation of subjective efficacy and safety of XXXX in Japanese subjects with @entity22 .

@entity1 @entity12123 @entity25 @entity22
OBJECTIVE: To assess @entity1 -reported efficacy and safety of @entity12123 in Japanese @entity1 with @entity22 . METHODS: Randomized, double-blind, placebo-controlled, multicenter trial. After a placebo lead-in period, 987 adults with @entity22 received @entity12123 8 mg or placebo once daily for 2 weeks, followed by a placebo run-out period to monitor rebound @entity22 . @entity1 -reported sleep data were collected using sleep diaries. RESULTS: @entity12123 significantly reduced mean @entity1 -reported sleep latency (primary endpoint) compared with placebo during week 1 (-4.54 min; p=0.001). @entity12123 maintained greater efficacy in sleep latency than placebo at week 2, but the difference did not achieve statistical significance. In a subset of @entity1 who adhered to treatment and completed their diaries as instructed, a statistically significant @entity25 was sustained through week 2. Compared with placebo, @entity12123 also significantly improved mean total sleep time and mean sleep quality during week 1, the number of awakenings during week 2, and overall @entity1 global impression scores. There was no evidence of rebound @entity22 . Adverse events were generally mild and transient. CONCLUSIONS: In Japanese adults with @entity22 , @entity12123 8 mg significantly reduced @entity1 -reported sleep latency, increased total sleep time and improved sleep quality after 1 week of treatment. @entity12123 was generally well tolerated with no rebound @entity22 .
