P:People who take over-the-counter melatonin supplements for better sleep may be getting more or less of the drug than they think, according to new research published April 24. JAMA. In an analysis of 25 different chewing gum supplements that claimed to contain melatonin, researchers from the Cambridge Health Alliance and the University of Mississippi found that 22 of them contained dramatically different amounts than stated on the bottle.
The 22 mislabeled products were found to contain melatonin ranging from 74% to 247% of the amount stated on their labels. One contains no melatonin at all. Lead author Dr. Peter Cohen, an associate professor at Harvard Medical School and an internist at the Cambridge Health Alliance, said he was not surprised. Although melatonin supplements have long been “regarded as relatively safe,” the US Food and Drug Administration (FDA) does not regulate supplements as strictly as they do over-the-counter drugs. “Supplement manufacturers don’t need to keep the FDA happy,” he says. As for the numbers, “they don’t have to prove anything to the agency, so they do what they want. Not having to deal with quality control makes things a lot cheaper.”
Cohen decided to take a closer look at melatonin gum after a 2022 report found that calls to US poison control centers for melatonin consumption by children increased more than 500% between 2012 and 2021. ,” she says, and the gummies are especially appealing to children, who may mistake medicine for candy. While most children were fine, nearly 20% of poison control calls reported some symptoms, which included gastrointestinal upset, cardiovascular symptoms, and more. Melatonin has not been well studied in children, although about 10% of US parents have at least one child who takes it. Consumer Reports.
read more: What science says about the health benefits of vitamins and supplements
Previous research has also found that melatonin supplements vary widely in the amount of the drug they contain. A 2017 Canadian study found that 71% of over-the-counter supplements tested, some of which were likely also sold in the U.S. at the time, had melatonin dosages mislabeled by at least 10%, the same threshold that the new paper is used. That these findings were essentially replicated more than five years later with a newer generation product shows how the underregulated supplement market in the U.S. doesn’t provide a real incentive for manufacturers to change, Cohen said.
Because melatonin is a hormone made in the brain that is released to make us feel tired when it gets dark outside, companies often emphasize in their marketing that the top part of melatonin supplements is “natural.” But many of their actual doses far exceed what the body produces on its own, Cohen says. “What we do know is that if you give a 20-year-old adult a very small amount of melatonin in the morning, like a 10th of a milligram or three 10ths of a milligram, it raises their levels to the normal nighttime levels. says Cohen. Popular over-the-counter supplements often claim to contain up to five or even 10 milligrams per dose. Given the unpredictable doses found in Cohen’s study, a nighttime melatonin regimen can multiply what the body can produce.
If melatonin has worked for you in the past, or you want to try it, there are ways to protect yourself from overdosing, Cohen says. Look for supplements with a high-quality third-party seal of approval that come from organizations such as the United States Pharmacopeia (USP) or NSF International, which test and approve certain supplement manufacturers.
But before you try melatonin, consider cleaning up your sleep habits first to see if it helps. Taking melatonin isn’t like “listening to classical music to fall asleep or drinking a glass of warm milk,” Cohen says. “A little extra classical music won’t hurt you. Melatonin is a drug.”
More must-reads from TIME