Nearly 15% of adults reported having trouble falling asleep most or every day in the past 30 days, according to a national survey. Meanwhile, research shows that more people are turning to a popular and readily available over-the-counter (OTC) sleep aid: melatonin supplements.
That doesn’t surprise Brienne Miner, MD, MHS, a Yale Medicine geriatric and sleep medicine specialist. She explains that it's generally safe to take a melatonin supplement—a synthetic version of the hormone produced in the brain that helps regulate the sleep-wake cycle.
“I think that's why we see it being used more and more, especially in older people, and especially as people become—appropriately—less comfortable with prescription sleep aids, which can have many side effects,” Dr. Miner says. For older adults, in particular, these side effects can include cognitive problems, falls, driving impairment, and more.
Yet, while melatonin supplements appear to be safe, the Food and Drug Administration (FDA) does not regulate dietary supplements as it does medications. For example, the agency does not approve supplements for safety or efficacy before they are sold, but can take action against misbranded or adulterated products after they are on the market.
In addition, a 2023 study published in the Journal of the American Medical Association found that the actual amount of melatonin in tested products ranged from 74% to 347% of the amount on the label, and 22 of the 25 products tested were inaccurately labeled. Some independent, “third-party” groups, such as NSF or the United States Pharmacopeia, test supplements for their ingredients and the presence of contaminants, but the FDA does not have oversight over these organizations.
Below, Dr. Miner talks more about melatonin supplements.