Most Melatonin Gummies Mislabeled, New Study Finds

The over-the-counter supplements frequently contain more melatonin than advertised and may not be the best approach to sleep issues.

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Melatonin gummies have widespread appeal: They’re affordable and easily available, and they come in a variety of fruity flavors. But the chewable supplements also have a big downside, according to a new research letter in the Journal of the American Medical Association.

The new study, published on April 25, found that in an examination of 25 melatonin gummy brands, 22 of them were labeled inaccurately — in some cases, dramatically so. Though one supplement had only three-quarters of the amount of melatonin listed, most contained significantly more melatonin than indicated, “all the way up to almost 350%” of what was on the label, said Dr. Pieter Cohen, lead author of the study and an internist with Cambridge Health Alliance.

In addition to the “trend toward excessive amounts of melatonin,” the other big surprise was the presence of CBD: Five of the brands listed CBD on the label, which showed that the manufacturers were trying to sell CBD as a dietary supplement, he said. (Doing so is against FDA regulations). And one of the melatonin gummy brands contained no melatonin whatsoever, just CBD.

Melatonin is classified as a dietary supplement — why that matters

In the United States, melatonin is sold as a dietary supplement. Not only does this mean it can be sold without a prescription, it also means it’s subject to more lenient requirements than products labeled as over-the-counter medications and doesn’t require formal approval by the U.S. Food and Drug Administration before hitting the shelves.

When evaluating the amount of melatonin in each product, Cohen looked at whether the amount of melatonin listed on the labels was within 10% of what the products actually contained. “It seems reasonable that consumers and clinicians should expect that the label is accurate, give or take 10%, when pharmacologically active substances like melatonin are sold,” he explained. And even though three of the 25 brands studied met this criteria, none of them actually contained the same amount specified on the label.

The results were based on a one-time analysis of the brands they studied, Cohen pointed out, comparing it to “what you might happen to get if you just walked into the store.”

Although his analysis focused on gummies, a 2017 Canadian study found that the amount of melatonin in a range of supplements available — including liquids, tablets, and pills — also varied substantially.

Adults in the United States who use non-gummy forms of melatonin should be similarly wary about what they contain. “I would guess that there’s going to be equal issues with the other formulations,” said Cohen, who’s researched dietary supplements extensively. “When you take a look at the actual contents of dietary supplements, very often due to poor manufacturing practices, the quality is very poor, and the label doesn’t line up with the actual ingredients. And this is a pattern we’ve seen.”

Use of melatonin has increased among both adults and children

The use of melatonin has been on the rise in recent years, with an estimated 2.1% of U.S. adults turning to the supplements to help with sleep.

Though the supplements come in several forms, including gummies, sprays, capsules, and tablets, the gummies particularly concerned Cohen, following last year’s report by the Centers for Disease Control and Prevention on calls to national poison control centers about pediatric melatonin ingestions. From 2012 to 2021, the annual number of reported melatonin ingestions for babies through teens increased 530%. The vast majority of these, 94%, were unintentional.

The report also found that 84% of melatonin ingestions were by kids under age 5. There was also an increase in the number of pediatric hospitalizations due to melatonin ingestion, including two deaths.

These numbers mirror emergency department trends noted in a just-released report, which found that from 2009 to 2020, melatonin-related emergency department visits for kids under age 5 were up 421%.

Neither study specified the type of melatonin that had been ingested, but Cohen focused on gummies because of their obvious appeal to children.

He recommends that parents keep melatonin gummies safely secured where they can’t be accidentally accessed by young kids, who may mistake them for candy. “This is a medical hormone that’s being used just like an over-the-counter drug,” he said. “Treat it like an over-the-counter medication, like Benadryl. You wouldn’t have that lying around, especially in an edible form that kids can get into.”

Why adults use melatonin —and what to do instead

It’s easy to see why so many adults are attracted to the idea of a melatonin supplement to help with their sleep. Survey results published last November in JAMA showed that only about one-fourth of adults in the United States get at least seven hours of sleep on workdays (the minimum recommended amount). A similar number said they felt sleepy during the day at least five days per month. Nearly 30% were troubled enough by their sleep that they’d raised the topic with their health care provider.

The issue with turning to melatonin, though, is that it’s not actually a sleeping pill — it’s a hormone, produced mainly by the pineal gland, that primes us to feel sleepy. As a supplement, “it was never intended to be a hypnotic,” said Dr. Chris Winter, a neurologist in private practice in Charlottesville, Virginia, who’s also a advisor and host of the “Sleep Unplugged” podcast.

“Melatonin is not intended to help you fall asleep or make you sleepy,” he explained. “It’s intended to align our bodies with the 24-hour rhythm that is the circadian rhythm.”

Given this, it can be useful to help address situations where the natural sleep-rhythm cycle is out of sync due to overnight work schedules, jet lag, or circadian disorders.

“It’s more about trying to change their circadian rhythm,” said Winter, “to adjust to whatever their circumstances are in a more accelerated fashion.”

Even so, it’s best to work with a sleep specialist to determine the best dosage and timing. The amount released by our brains is in the range of 10 to 80 micrograms per night, he pointed out. By comparison, the amount of melatonin in the gummies studied by Cohen ranged from 1 to 10 milligrams per serving as listed on the label, and far more than that in actuality. (For reference, 10 micrograms equals .01 milligrams.)

Plus, melatonin that’s ingested functions far differently than the melatonin released by the brain. A lot of it gets “degraded” and doesn’t cross the blood-brain barrier, Winter explained. “The amount that’s actually reaching your brain and having any kind of effect on sleep can be vanishingly small.”

Particularly in light of the issues with melatonin labeling, taking melatonin supplements can be “a complete lottery,” he added.

Nevertheless, for consumers who are still intent on taking a supplement, Cohen recommends choosing one that’s been certified by a third-party organization, specifically USP or NSF, whose processes entail extensive evaluations and repeated testing. “It doesn’t mean it will work as advertised,” Cohen pointed out. “But at least they’ll tell you if it says 5 milligrams, you’ll get 5 milligrams.”

Moreover, taking a supplement doesn’t address why you’re having trouble sleeping, Winter said.

“There are a lot of things that go into bad sleep, and they need to be explored,” said Winter, with a goal of “working toward a more meaningful solution.”

That starts with sleep hygiene, which can include addressing the temperature and lighting of the bedroom, as well as reevaluating habits that may be eroding your sleep, such as caffeine use or long naps. It also means being intentional about winding down for bed, including establishing a routine to help ease the transition to sleep, and being mindful of tech use.

Depression and other mental-health issues can also play a role, as can hormonal changes. And there may also be underlying issues, such as sleep apnea or restless leg syndrome, that are affecting sleep.

Having realistic expectations helps too. Winter noted that a goal of falling asleep fast isn’t a great metric, and may actually be a sign that someone’s sleep-deprived or has an underlying issue.

Cognitive behavioral therapy, which addresses thought patterns about sleep, can be very effective in addressing insomnia and other sleep concerns. It involves breaking down beliefs about sleep, Winter explained: “What are you feeling when you go to bed, and why? Is it rooted in something that’s real? And how can we train and reconfigure your relationship with going to bed?”

If you’re stressed about not falling asleep, “let’s reevaluate how sleep works and your approach to it,” he said. “And that starts with understanding that it’s impossible not to sleep.”