Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

Summary

This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.

Timeline

Start

2006-10

Primary completion

2008-12

Completion

2009-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Circadin vs Placebo; p <0.05; Mean Difference (Final Values) -15.6 (95% CI -25.3 to -6); ANCOVA NCT00397189 ↗

Publications

• Wade AG, Crawford G, Ford I, McConnachie A, Nir T, Laudon M, Zisapel N. Prolonged release melatonin in the treatment of primary insomnia: evaluation of the age cut-off for short- and long-term response. Curr Med Res Opin. 2011 Jan;27(1):87-98. doi: 10.1185/03007995.2010.537317. Epub 2010 Nov 24.
• Wade AG, Ford I, Crawford G, McConnachie A, Nir T, Laudon M, Zisapel N. Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety. BMC Med. 2010 Aug 16;8:51. doi: 10.1186/1741-7015-8-51.

Drugs

Indications