Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

Summary

This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once daily (QD), in elderly participants with chronic insomnia.

Timeline

Start

2002-12

Primary completion

2004-01

Completion

2004-01

Outcome

Met primary endpoint

paper Both doses of ramelteon produced statistically significant reductions in sleep latency vs. placebo at week 1 PMID 16709464 ↗

Publications

• Results Mini LJ, Wang-Weigand S, Zhang J. Self-reported efficacy and tolerability of ramelteon 8 mg in older adults experiencing severe sleep-onset difficulty. Am J Geriatr Pharmacother. 2007 Sep;5(3):177-84. doi: 10.1016/j.amjopharm.2007.09.004.
• Results Roth T, Seiden D, Sainati S, Wang-Weigand S, Zhang J, Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006 Jun;7(4):312-8. doi: 10.1016/j.sleep.2006.01.003. Epub 2006 May 18.

Drugs

Indications