Effects of Ramelteon on Driving Ability

Summary

The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.

Timeline

Start

2006-03

Primary completion

—

Completion

2006-07

Outcome

Missed primary endpoint

paper SDLP was significantly increased after the intake of ramelteon (+2.2 cm) and zopiclone (+2.9 cm). PMID 21966064 ↗

paper Ramelteon (8 mg) and zopiclone (7.5 mg) significantly impaired driving performance, cognitive, memory, and psychomotor performance the morning following bedtime administration. PMID 21966064 ↗

Publications

• Mets MA, de Vries JM, de Senerpont Domis LM, Volkerts ER, Olivier B, Verster JC. Next-day effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects. Sleep. 2011 Oct 1;34(10):1327-34. doi: 10.5665/SLEEP.1272.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	8 mg	—
Subject	Zopiclone	Small molecule	7.5 mg	—

Indications