Melatonin in Medically Ill Patients With Insomnia: A Double-Blind, Placebo-Controlled Study

Background: It has been suggested that melatoninimproves sleep functioning, but this possibility has not beenstudied in medical populations.

Method: 33 medically ill persons with initialinsomnia were randomly assigned to receive either melatonin (N =18) or placebo (N = 15) in a flexible-dose regimen. Double-blindassessments of aspects of sleep functioning were obtained dailyacross the next 8 to 16 days.

Results: The mean stable dose of melatonin wasfound to be 5.4 mg. Relative to placebo, melatonin significantlyhastened sleep onset, improved quality and depth of sleep, andincreased sleep duration without producing drowsiness,early-morning “hangover” symptoms, or daytime adverseeffects (p < .05). Melatonin also contributed to freshness inthe morning and during the day and improved overall daytimefunctioning. Benefits were most apparent during the first week oftreatment.

Conclusion: Melatonin may be a useful hypnoticfor medically ill patients with initial insomnia, particularlythose for whom conventional hypnotic drug therapy may beproblematic.