In a randomized, placebo-controlled, multi-center study involving 170 primary insomnia outpatients (aged 55 years or older), treatment with prolonged-release melatonin (2 mg/d) for a period of 3 weeks was found to improve quality of sleep and morning alertness, without producing any rebound insomnia or withdrawal effects after discontinuation of treatment.
Improvements in quality of sleep and morning alertness were strongly correlated, suggesting “a beneficial treatment effect on the restorative value of sleep.” When the effects of prolonged-release melatonin were assessed in a subgroup of subjects with greater symptom severity, similar beneficial effects were found. Adverse events were not common, with most side-effects considered minor. The authors conclude, “PR-melatonin is the first drug shown to significantly improve quality of sleep and morning alertness in primary insomnia patients aged 55 years and older.”
“Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects,” Lemoine P, Nir T, et al, J Sleep Res, 2007; 16(4): 372-80. (Address: Nava Zisapel, Department of Neurobiochemistry, The George S Wise Faculty of Life Sciences, Tel Aviv University, Tel Aviv 69978, Israel.
Tishcon Senior Scientist Comment:
Since drugs can lead to dependence, it may be appropriate to try Prolonged Release (Timed Release) Melatonin 2 to 3 mg per day, 60 minutes before bedtime for the treatment of insomnia.