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May 21, 2023

22 Out of 25 Melatonin Products Were Mislabeled, Study Finds

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New research found that the gummies contained different amounts of the commonly used sleep aid than advertised.

By Dani Blum

A tiny, berry-flavored gummy of melatonin carries a big promise: better sleep. But a new research paper, published in the medical journal JAMA on Tuesday, highlights a critical issue: When it comes to melatonin, as with other supplements, what you see on the label isn't always what you get.

A team of researchers analyzed 25 melatonin gummy products from different brands and found that 22 contained different amounts of melatonin than what was listed on their labels; one contained only 74 percent of the advertised amount of melatonin, while another had 347 percent of the labeled amount. Yet another product contained no detectable melatonin at all.

Researchers tested gummies from only a single bottle of each product, so it's possible that the amount of melatonin varied from batch to batch. But the findings point to a staggering discrepancy between the amount of melatonin consumers think they’re ingesting and how much they might actually take, said Dr. Pieter Cohen, an associate professor at Harvard Medical School and the lead author of the paper.

"You are at the mercy of the dietary supplement industry," Dr. Cohen said.

The Food and Drug Administration does not evaluate dietary supplements for their safety and effectiveness. "Protecting the health and safety of Americans is the F.D.A.'s highest priority, and we will remain vigilant in warning consumers when public health concerns arise related to dietary supplement products," a representative for the agency said in a statement.

Previous research has highlighted just how varied the quality of melatonin products can be; a 2017 study in Canada found that one melatonin supplement contained more than 400 percent of the amount listed on the label. Dr. Cohen's study examined only gummies and focused on products sold in the United States. The number of Americans using melatonin supplements more than quintupled between 1999 and 2018, according to the National Institutes of Health.

Our brains are wired to naturally produce melatonin after the sun sets. The hormone helps to regulate our circadian rhythms, signaling to our bodies that it's time to sleep. Melatonin supplements purport to complement, or enhance, that process.

An accurately labeled three-milligram gummy contains roughly a thousand times as much melatonin as the amount our brains naturally produce, said Philip Gehrman, an associate psychiatry professor at the Perelman School of Medicine of the University of Pennsylvania. The excess melatonin found in a large dose is likely to just break down in the body and be excreted, he said; it probably won't help you fall asleep any faster.

The higher the dose of melatonin, the more likely you are to experience side effects, said Dr. Sabra Abbott, a sleep medicine specialist at the Northwestern Feinberg School of Medicine. Large amounts of melatonin aren't likely to be dangerous for most adults, experts say, but some people report feeling groggy or hung-over the morning after taking the supplement, or having vivid, unnerving dreams.

Melatonin gummies can pose serious risks to children if they consume too many. Calls to the American Association of Poison Control Centers related to pediatric melatonin consumption jumped 530 percent from 2012 to 2021, according to research published last summer.

"They are not candy," Dr. Brian Chen, a sleep specialist at Cleveland Clinic, said. "They aren't just to be taken willy-nilly."

There's no guarantee that any given bottle of melatonin gummies will actually contain the amount listed on the label. Still, experts recommended a few precautions for those who decide to take melatonin:

Instead of ordering melatonin online or wandering through the aisles of a pharmacy and picking a supplement at random, Dr. Gehrman said, ask a pharmacist to suggest a trusted brand.

Experts say you should opt for a product that has been certified by a third-party organization like the U.S. Pharmacopeia, which vets different supplements.

Opt for one milligram of melatonin or less, Dr. Abbott said. A larger dose isn't likely to be more effective at helping you sleep.

Even with a supplement as seemingly innocuous as melatonin, you should talk with a physician before trying it, experts say.

It's also important to think about why you’re taking melatonin in the first place, Dr. Chen said. Many people who turn to melatonin are taking it incorrectly by trying to induce sleep right before bed, looking for a quick fix when an intervention like cognitive behavioral therapy might be more beneficial for treating insomnia.

"It takes work and effort to learn this lost art of sleep," he said.

Dani Blum is a reporter for Well.

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