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ORIGINAL ARTICLES

The effect of prolonged-release melatonin on sleep measures and psychomotor performance in elderly patients with insomnia

Luthringer, Remya; Muzet, Muriela; Zisapel, Navac; Staner, Lucb

Author Information

aFORENAP Pharma

bFORENAP-FRP (Institute for Research in Neurosciences, Neuropharmacology and Psychiatry), Rouffach, France

cDepartment of Neurobiology, The George S. Wise Faculty of Life Sciences, Tel Aviv University and Neurim Pharmaceuticals, Tel Aviv, Israel

Correspondence to Professor Nava Zisapel, PhD, Department of Neurobiology, The George S Wise Faculty of Life Sciences, Tel Aviv University, Tel Aviv 69978, Israel

Tel: +972 3 640 9611; fax: +972 3 640 7643; e-mail:[email protected]

Received 21 January 2009 Accepted 26 May 2009

International Clinical Psychopharmacology24(5):p 239-249, September 2009. |DOI:10.1097/YIC.0b013e32832e9b08

Abstract

Objectives of this study were to investigate the effects of prolonged-release melatonin 2 mg (PRM) on sleep and subsequent daytime psychomotor performance in patients aged ≥55 years with primary insomnia, as defined by fourth revision of theDiagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association. Patients (N = 40) were treated nightly single-blind with placebo (2 weeks), randomized double-blind to PRM or placebo (3 weeks) followed by withdrawal period (3 weeks). Sleep was assessed by polysomnography, all-night sleep electroencephalography spectral analysis and questionnaires. Psychomotor performance was assessed by the Leeds Psychomotor Test battery. By the end of the double-blind treatment, the PRM group had significantly shorter sleep onset latency (9 min;P = 0.02) compared with the placebo group and scored significantly better in the Critical Flicker Fusion Test (P = 0.008) without negatively affecting sleep structure and architecture. Half of the patients reported substantial improvement in sleep quality at home with PRM compared with 15% with placebo (P = 0.018). No rebound effects were observed during withdrawal. In conclusion, nightly treatment with PRM effectively induced sleep and improved perceived quality of sleep in patients with primary insomnia aged ≥55 years. Daytime psychomotor performance was not impaired and was consistently better with PRM compared with placebo. PRM was well tolerated with no evidence of rebound effects.

© 2009 Lippincott Williams & Wilkins, Inc.

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