The Effect of Prolonged-Release Melatonin on Sleep Measures and Psychomotor Performance in Elderly Patients With Insomnia

Int Clin Psychopharmacol. 2009 Sep;24(5):239-49. 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 > or =55 years with primary insomnia, as defined by fourth revision of the Diagnostic 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 > or =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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Delayed-Action Preparations
  • Double-Blind Method
  • Electroencephalography
  • Female
  • Humans
  • Male
  • Melatonin / administration & dosage
  • Melatonin / pharmacology*
  • Melatonin / therapeutic use*
  • Middle Aged
  • Polysomnography
  • Psychomotor Performance / drug effects*
  • Sleep / drug effects*
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Sleep Initiation and Maintenance Disorders / physiopathology
  • Surveys and Questionnaires

Substances

  • Delayed-Action Preparations
  • Melatonin