Safety and Efficacy of Ramelteon in Healthy Subjects

Summary

The purpose of this study is to determine the phase-advance in circadian rhythms in healthy adults subjects taking ramelteon, once daily (QD).

Timeline

Start

2005-03

Primary completion

2005-05

Completion

2005-05

Outcome

Met primary endpoint

paper participants receiving 1, 2, or 4 mg ramelteon exhibited statistically significant phase shifts in DLMoff PMID 18853704 ↗

paper versus -7.1 (18.6) minutes for placebo (least-squares mean(SEM), p = 0.002, p = 0.003, p = 0.001, respectively). PMID 18853704 ↗

Publications

• Results Richardson GS, Zee PC, Wang-Weigand S, Rodriguez L, Peng X. Circadian phase-shifting effects of repeated ramelteon administration in healthy adults. J Clin Sleep Med. 2008 Oct 15;4(5):456-61.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	1 mg	Oral
Subject	Ramelteon	Unknown	2 mg	Oral
Subject	Ramelteon	Unknown	4 mg	Oral
Subject	Ramelteon	Unknown	8 mg	Oral

Indications