Melatonin in medically ill patients with insomnia: A double-blind, placebo-controlled study

Background: It has been suggested that melatonin improves sleep functioning, but this possibility has not been studied in medical populations. Method: 33 medically in persons with initial insomnia were randomly assigned to receive either melatonin (N = 18) or placebo (N = 15) in a flexible-dose regimen. Double-blind assessments of aspects of sleep functioning were obtained daily across the next 8 to 16 days. Results: The mean stable dose of melatonin was found to be 5.4 mg. Relative to placebo, melatonin significantly hastened sleep onset, improved quality and depth of sleep, and increased sleep duration without producing drowsiness, early-morning "hangover" symptoms, or daytime adverse effects (p < .05). Melatonin also contributed to freshness in the morning and during the day and improved overall daytime functioning. Benefits were most apparent during the first week of treatment. Conclusion: Melatonin may be a useful hypnotic for medically ill patients with initial insomnia, particularly those for whom conventional hypnotic drug therapy may be problematic.