Melatonin Agonist May Protect Against Delirium

A new study not only adds to the evidence that low levels of the pineal hormone melatonin are implicated in delirium, but suggests that correcting these low levels might be able to prevent delirium. The study, titled "Preventive Effects of Ramelteon on Delirium," was headed by Kotaro Hatta, M.D., Ph.D., a psychiatrist at Juntendo University in Japan. The results appear in JAMA Psychiatry.

The study by Hatta and his coworkers included 67 older hospitalized patients. Half received a melatonin agonist called ramelteon nightly and half received a placebo. Only three percent of the subjects getting ramelteon developed delirium, whereas 32 percent of placebo subjects did--a significant difference.

"This is an interesting study despite the small size of the sample," Gary Kennedy, M.D., a professor of psychiatry at Albert Einstein College of Medicine and director of the Division of Geriatric Psychiatry at Montefiore Medical Center, said in an interview. "It reinforces the novel theory that melatonin is involved in the genesis of delirium and would explain in part why older adults are more likely to develop delirium. The potential of ramelteon to reduce the risk of delirium is especially appealing because of its low adverse reactions, unlike antipsychotics that are so often used when delirious behavior threatens the patient's well-being."

Ramelteon has been approved by the U.S. Food and Drug Administration to treat insomnia.

More information about diagnosing and treating delirium can be found in American Psychiatric Publishing's new Clinical Manual of Geriatric Psychiatry.

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FDA Issues Warning About “Lazy” Brownies

Baked brownie-like treats laced with melatonin, marketed as "relaxation treats" and sold over the counter in convenience stores and online, are causing anxiety among federal regulators. One such product, previously marketed as “Lazy Cakes,” is now known as “Lazy Larry.” Last Thursday, the Food and Drug Administration (FDA) sent a warning letter to a manufacturer of the products, Baked World/HBB, advising that “there is no food additive regulation that authorizes the use of melatonin.” In the letter, the FDA described melatonin as a “neurohormone used for medicinal purposes, primarily as a sleep aid,” and said that reports in the scientific literature have raised safety concerns about its use. The FDA gave Baked World 15 days to respond with a plan for addressing the violation.

Consumers may be turning to these "relaxation treats" when they suffer from insomnia. Read Psychiatric News to learn why is is crucial that sleep problems be evaluated and treated by a sleep-medicine specialist at http://pn.psychiatryonline.org/content/46/2/27.full.

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