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October 2, 1996

Melatonin Potentially Useful but Safety, Efficacy Remain Uncertain

Author Affiliations

JAMA contributor

JAMA. 1996;276(13):1011-1014. doi:10.1001/jama.1996.03540130009003

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MELATONIN users are the unwitting subjects in a large-scale uncontrolled experiment, according to specialists in sleep and biological rhythms attending a workshop on melatonin and sleep at the National Institutes of Health (NIH) in Bethesda, Md, in August. The scientists urged the NIH to support a multicenter controlled clinical trial to determine melatonin's efficacy and long-term safety.

The widespread use of melatonin, the scientists said, highlights the pervasiveness of sleep disorders and the need for physicians to give more weight to sleep complaints. Although no medical catastrophes are known to be associated with melatonin, until solid evidence is in, they said, physicians should prescribe pharmacological and behavioral treatments of known value for sleep disorders, caution patients against the chronic use of melatonin, and monitor those who do take it.

The workshop was sponsored by the Trans-NIH Sleep Research Coordinating Committee and the NIH Office for Dietary Supplements. Its spirited and