Researchers Issue Melatonin Gummy Warning

Buyer beware: Chewable melatonin supplements sold as over-the-counter sleep aids may contain potentially dangerous levels of the hormone, according to a research team that tested 25 gummy sleep products.

The researchers found that 22 of the 25 products sampled contained significantly different amounts of melatonin than advertised. One contained no melatonin but did contain 31.3 mg of cannabidiol (CBD), a chemical found in the cannabis plant. Another had gummies packing nearly 3.5 times more melatonin than the labeled quantity.

“The great majority of melatonin gummy products were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD,” wrote lead author Pieter Cohen, M.D., of Cambridge Health Alliance, in Somerville, Massachusetts, in a research letter published in JAMA Network.

Dietary supplements, such as these gummy products, are not approved by the U.S. Food and Drug Administration, but the FDA can take action if a product on the market is found to be unsafe or otherwise out of compliance with the law. As to CBD, the FDA has serious safety concerns and notes that it is illegal to include it in foods or label it as a dietary supplement. 

What the researchers did

Cohen and his colleagues purchased online 25 gummy sleep-aid brands labeled as containing melatonin that they found in the National Institutes of Health’s Dietary Supplement Label Database in 2022. They then tested the products for the presence and quantity of melatonin, CBD and serotonin, a naturally occurring chemical that helps regulate sleep and other bodily functions. (No serotonin was found in any of the products.)

What they found

Among the 24 products that contained melatonin, the quantity ranged from 1.3 mg to 13.1 mg per serving size. Compared to what was on the label, actual melatonin quantity ranged from 74 percent to 347 percent.

Only three products had melatonin levels within 10 percent of what was advertised on the label.