Effect of melatonin administration on sleep, behavioral disorders and hypnotic drug discontinuation in the elderly: a randomized, double-blind, placebo-controlled study.

BACKGROUND AND AIMS: The aim of the study was to evaluate the effect of melatonin administration on sleep and behavioral disorders in the elderly and the facilitation of the discontinuation of regular hypnotic drugs.
METHODS: This was a prospective, randomized, double-blind, placebo-controlled, crossover trial in a community-living population. Participants were 22 older adults (7 men, 15 women over 65) with a history of sleep disorder complaints. Fourteen of these subjects were receiving hypnotic drug therapy. Participants received 2 months of melatonin (5 mg/day) and 2 months of placebo. Sleep disorders were evaluated with the Northside Hospital Sleep Medicine Institute (NHSMI) test, discarding secondary insomnia and evaluating sleep quality. Behavioral disorders were evaluated with the Yesavage Geriatric Depression Scale (GDS) and Goldberg Anxiety Scale (GAS). Patients discontinuing hypnotic drugs were also recorded.
RESULTS: Melatonin treatment for two months significantly improved sleep quality scores measured by the NHSMI test (1.78+/-0.40) when compared with both basal (3.72+/-0.45; p=0.001) and placebo (3.44+/-0.56; p=0.025) groups. Depression measured by GDS and anxiety measured by GAS also improved significantly after melatonin administration (p=0.043 and p=0.009, respectively). Nine out of 14 subjects receiving hypnotic drugs were able to discontinue this treatment during melatonin but not placebo administration; one discontinued hypnotic drugs during both melatonin and placebo administration, and four were unable to discontinue hypnotic therapy.
CONCLUSIONS: The results of this study suggest that melatonin administration significantly improves sleep and behavioral disorders in the elderly and facilitates discontinuation of therapy with conventional hypnotic drugs.

RCT Entities:   Population Interventions Outcomes