Some sleep-aid gummies contain over 300% more melatonin than labeled, study finds

Amid a sixfold rise in poisonings from melatonin supplements among U.S. children over the past decade, a study released Tuesday sheds light on how unregulated the sleep aid actually is. 

Because melatonin is sold as a supplement, it’s not regulated as a drug – so the U.S. Food and Drug Administration doesn’t have oversight over ingredient content or accuracy.

Widely sold in tablet and capsule form, melatonin is also available as a gummy formulation.

In Tuesday’s study published in the Journal of the American Medical Association, researchers analyzed 25 gummy products from different brands. Most contained much more melatonin than labeled – between 74% to over 300% above the labeled quantity, the team found.

Parents will sometimes give the supplement to their children to help them sleep, but according to a federal study last year, surges in poison calls were driven by “unintentional ingestions.” 

Experts are warning parents about the inaccurately labeled products and dangers of overconsumption, encouraging them to seek guidance from their pediatricians.

“Because melatonin is a hormone, it should be treated like a medication," said lead author, internist Dr. Pieter Cohen, a Harvard Medical School associate professor. "It's best to not just try it just willy-nilly and best to talk to the pediatrician."

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What is melatonin?

A hormone that helps with the body’s sleep cycle, melatonin is an over-the-counter supplement that people often take to help them sleep or relax.

Generally, a safe amount to consume is between 1 and 5 milligrams, and even below 1 milligram can be effective, according to the Sleep Foundation.

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How much is actually in the melatonin supplements? 

According to the study, the quantity of melatonin in a single serving size was found to be much higher – ranging from 1.3 to 13.1 milligrams.

And most didn't line up with what was labeled, Cohen and his team found. Only three of the 25 gummy products had a melatonin amount within 10% of the labeled quantity. 

There is no established maximum safe dose of melatonin. According to those amounts found in the gummies, the team estimated children can be exposed to between 40 and 130 times higher quantities of melatonin than is recommended.

Additionally, one of the 25 supplements studied didn’t contain melatonin at all, but instead contained CBD. The FDA has not approved the use of CBD for health reasons for children. The substance is only approved as part of a treatment for seizures caused by three rare genetic disorders, the authors wrote.

Steve Mister, CEO of the Council for Responsible Nutrition that represents supplement manufacturers, dismissed the findings, saying “supplement companies go to great lengths" to ensure safety and accuracy of labels. He added that children could be consuming more than the recommended serving size.

Can you overdose on melatonin? What are the side effects?

Excess melatonin consumption hasn't been shown to be fatal and so far there isn't evidence of long-term problems from short-term use of melatonin.

But troubling side effects can occur from taking too much melatonin. Trouble breathing, vomiting and excessive sleepiness are symptoms of too much.

Additionally, it can interact with some medications, so consult your doctor first. People with epilepsy and those taking certain medications like benzodiazepines and blood thinners should especially use caution.

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What do we know about melatonin poisonings among kids?

According to the study published by the Centers for Disease Control and Prevention last year, calls to U.S. Poison Control Centers for pediatric melatonin ingestions surged sixfold from 2012, when there were 8,337 calls, to 2021, when there were more than 52,500 calls.

The largest increase, about 38%, was during the start of the pandemic, from 2019 to 2020.

According to the study, melatonin ingestions were associated with:

• more than 27,000 visits to a health care facility
• 4,097 hospitalizations
• 287 intensive care unit admissions
• Two deaths

“We really don't know what's within any of these supplements,” said Seattle Children’s Hospital pediatrician Dr. Cora Collette Breuner, who wasn’t involved in the study and researches supplements, adolescent medicine and sleep.

Supplements can be helpful but should be used under medical guidance, Breuner said.

“People need to be aware that there are companies that are reputable and then those that may not have an independent lab testing capacity,” she said.

Melatonin and kids: How to protect your child

First, keep supplements and medicines out of reach of children.

Cohen and Breuner emphasized talking with a pediatrician and seeking supplements that have been assessed by a third-party, independent entity. You can do that by searching for products with a USP certification at usp.org.

A USP certification doesn’t guarantee a supplement will work as advertised. It just signals that the ingredients and amounts listed on the bottle match the contents, Cohen said.

Breuner suggested parents talk with a pediatrician about how to help a child sleep and develop good sleep hygiene routines. “That might be a better way to get our kids to sleep than dosing them with a product that we don't even know if it has anything in it,” she said.

Breuner hopes that studies like these bring more awareness to clinicians about the contents of a supplement, she said.

“It's extremely important to be aware that this industry has made its way into a lot of our practice of medicine,” she said. “Hopefully the companies that make these products will, in good faith, hire a third-party, objective and independent laboratory testing facility to make sure that the product (is) pure, not contaminated, and with consistent potency and purity.”

Reach Nada Hassanein at nhassanein@usatoday.com or on Twitter @nhassanein_.