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Melatonin poses risks, critics say
August 13, 1996
Web posted at: 10:00 p.m. EDTFrom Correspondent Jeff Levine
BETHESDA, Maryland (CNN) -- Are you convinced that melatonin is the next miracle drug? Doctors who have studied the hormone won't give it their stamp of approval yet.
Millions of Americans are thought to take melatonin, which is sold as a dietary supplement in health food stores. But doctors attending a National Institutes of Health conference in Maryland this week are worried about the rising popularity of the hormone as a treatment for insomnia.
Melatonin is produced by the body in large quantities at night, and is thought to control cycles of sleep and wakefulness. But buying the same drug in a bottle from the drugstore may not be such a good idea, doctors studying the drug say.
Why? First of all, the drug's purity and dosage, as sold over the counter, is not guaranteed. Second, even in measured and relatively low dosages, research on melatonin is inconclusive.
"We have this unprecedented situation where people are taking it in this kind of uncontrolled experiment, and so of course, we are kind of nervous about that," said Dr. Robert Sack of the Oregon Health Sciences University. (230K AIFF or WAV sound)
Co-worker Dr. Alfred Lewy agreed, and said he was cautioning patients not to self-prescribe melatonin "until this research can be further known to the public or to your doctors."
"It may be that you really should consult your physician before taking melatonin," Lewy said. "It is an active drug."
Small studies have shown melatonin tablets can ease the symptoms of insomnia or jet lag. There also have been claims that it can prevent cancer and other diseases. Critics say such unsubstantiated claims have hyped the drug's value.
"This far outstrips what we know about how it works, who should take it, what doses people should take. And this is, to some extent, scary," said Dr. Richard Wurtman of the Massachusetts Institute of Technology.
While there have been no reports of severe adverse reactions from melatonin, there are concerns that it could cause side effects ranging from dangerous drowsiness to stroke.
Wurtman cites one known side effect, hypothermia or low body temperature, as an example. "Why do we worry about that? Well, there are a lot of viral infections that move faster if your body temperature cannot rise," he said.
Because it is considered a food supplement, a law passed by Congress in 1994 largely stops the U.S. Food and Drug Administration from regulating melatonin.
Even though several melatonin researchers have patents on the hormone, they say their interest is public health, not profit. They are urging the federal government to finance the research that will show whether melatonin is in fact safe and effective.
The Associated Press contributed to this report.
Related stories:
- FDA can't assure safety of melatonin - March 5, 1996
- CNN investigation prompts nationwide recall - January 18, 1996
Related sites:
- National Institutes of Health
- Oregon Health Sciences University
- Massachusetts Institute of Technology
- Food and Drug Administration
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