Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

Summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep

Timeline

Start

2003-01

Primary completion

2003-09

Completion

2003-09

Outcome

Met primary endpoint

paper LPS at Week 1 (primary measure) was significantly shorter with ramelteon 8 mg (32.2 min) or 16 mg (28.9 min) vs placebo (47.9 min; p <0.001). PMID 17803013 ↗

Publications

• Results Zammit G, Erman M, Wang-Weigand S, Sainati S, Zhang J, Roth T. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. J Clin Sleep Med. 2007 Aug 15;3(5):495-504.
• Results Mini L, Wang-Weigand S, Zhang J. Ramelteon 8 mg/d versus placebo in patients with chronic insomnia: post hoc analysis of a 5-week trial using 50% or greater reduction in latency to persistent sleep as a measure of treatment effect. Clin Ther. 2008 Jul;30(7):1316-23. doi: 10.1016/s0149-2918(08)80056-2.
• Results Osborne, T, Louis, M, Wang-Weigand, S and Jie, Z. Treatment of insomnia in women and the melatonin receptor agonist ramelteon (Rozerem). Women's Health Care: A Practical Journal for Nurse Practitioners. 2008; 7: (6): 24-30
• Results Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527.

Drugs

Indications