Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder

A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder

The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.

Inclusion Criteria:

• Meets criteria for RBD as determined by screening PSG's
• steady bed partner for completion of RBD questionnaire

Exclusion Criteria:

• Hepatic impairment
• RBD associated with narcolepsy
• use of fluvoxamine, rifampin, fluconazole or ketoconazole
• current alcohol or drug abuse