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Researchers Issue Melatonin Gummy Warning

Dosages and ingredients in sleep aids are often inaccurate, may pose danger

spinner image close up of a woman pouring melatonin gummies out of an orange bottle into her hand
Grace Cary / Getty Images

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.

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“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.

Five of the products were labeled as containing CBD. Actual levels of cannabidiol were a bit higher than advertised, ranging from 104 percent to 118 percent of what was on the label.

Why it matters

Researchers in 2022 tracked a fivefold increase in melatonin use among U.S. adults in the past few decades, with many taking higher doses than what’s typically recommended — despite scant evidence that melatonin works for your run-of-the-mill shut-eye issues, including insomnia, AARP reported.


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Cohen and his colleagues point out that children are also being given melatonin to help with sleep, stress and relaxation. At the same time, they note a large increase in calls to poison control centers regarding children ingesting melatonin: a 530 percent increase (from 2012 to 2021) in calls concerning “pediatric melatonin ingestions.” Those calls were associated with “27,795 emergency department and clinic visits, 4,097 hospitalizations, 287 intensive care unit admissions, and 2 deaths.” 

“Given that children might intentionally or unintentionally ingest melatonin gummies, we assessed the actual quantity of melatonin and CBD in these products compared with the quantities declared on the labels,” the researchers said.

Cohen and his colleagues admit the sample size was small: Only a single gummy from each of the brands was analyzed. As such, the results may not reflect what would be found in other melatonin products sold as tablets or capsules. Also, the quantity of melatonin within individual brands could vary from batch to batch.

Still, they suggest health professionals should advise parents that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin and CBD.

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