Are Melatonin Gummies Safe For Kids? New Study Urges Caution

They taste like candy and promise a better night of sleep. Melatonin gummy vitamins sound too good to be true, especially for parents of sleepless children — and they may very well be.

In a new analysis, researchers found that some of these gummies contain higher doses of melatonin than the amount listed on the label. Some products may contain less than advertised or high doses of other ingredients, like cannabidiol (CBD).

The findings were published in a research letter in the journal JAMA on Tuesday, April 25. Out of the 25 melatonin gummy products analyzed by researchers, 22 (88%) were inaccurately labeled and only three (12%) contained an amount of melatonin within 10% of the amount declared on the label.

The actual amount of melatonin in these products ranged from 74% to 347% of the amount advertised, the authors wrote.

Melatonin is a hormone produced by the body that plays a role in sleep, per the Mayo Clinic, and is released by the brain in response to darkness. It’s commonly used as an over-the-counter sleep aid.

However, melatonin has not been shown to be an effective treatment for insomnia in children or adults and does not work in the way most people think it does, Dr. Brian Chen, a pediatric sleep expert at the Cleveland Clinic, tells TODAY.com.

He explains that melatonin works well to help your body set the time you should fall asleep because it can help regulate your circadian rhythm, but it doesn’t actually make you fall asleep. “It doesn’t knock you out like a sleep aid,” he adds.

So for children, even more so than adults, it’s not recommended to use to help them be able to go to sleep at night, Chen says.

One of the melatonin gummy products researchers tested did not contain any melatonin at all, but instead CBD, which is not approved for healthy children. Of the five gummy products that did declare CBD as an ingredient, researchers found the actual amount ranged from 104% to 118% of the labeled quantity.

“There’s even less information available to us on the use of CBD and sleep and safety in kids,” Dr. Caroline Martinez, a developmental-behavioral pediatrician and assistant clinical professor of pediatrics at Mount Sinai, tells TODAY.com. “We really don’t know a lot about its regular use on the typical developing brain,” Martinez adds.

Melatonin gummies, like other vitamins and dietary supplements, are regulated by the U.S. Food and Drug administration as foods, not drugs. The FDA does not approve the safety or effectiveness of these supplements, nor the accuracy of their labels, before they are sold to the public.

The study authors point out that it is unclear whether the quantity of melatonin may also vary between batches of the same product.

Many vitamins and supplements do not contain the quantity of ingredients advertised on the label, but the gummy versions tend to have more quality issues than tablets or capsules, TODAY.com previously reported.

Because gummies have a shorter shelf life and the ingredients lose potency faster than pills, companies will sometimes put a higher amount than labeled to compensate, an expert at ConsumerLab previously told TODAY.com.

Even if they are sold over-the-counter, vitamins and supplements can cause adverse effects. In children, melatonin can cause nausea, abdominal pain and headaches, TODAY.com previously reported. “We also see kind of hangover effects or grogginess in the morning … so it can have the opposite effect of what you want which is your kid being rested and alert and ready for the day,” she adds.

Melatonin has become increasingly popular over the past 20 years — despite the lack of high-quality evidence that it helps people sleep better — and use increased sharply during COVID-19 pandemic, TODAY.com reported previously. And so have melatonin poisonings among children.

According to the U.S. Centers for Disease Control and Prevention, between 2012 to 2021, the annual number of pediatric melatonin ingestions reported to poison control increased by 530%.

Last fall, the American Academy of Sleep Medicine issued new guidance around melatonin for children, recommending that parents do not give it to their kids without talking to a pediatrician first, TODAY.com previously reported.

“I think we have this kind of huge public health problem where we’re seeing a lot of difficulties with kids falling asleep,” says Martinez. Melatonin seems like an easy fix for parents, she says, because gummies are attractive to kids and it’s easily available.

The bottom line is there isn’t enough evidence to support the use of melatonin as a sleep aid in healthy children, the experts note, and there isn’t much research into the effects of long-term use either.

If adults want to take melatonin, Chen says the recommended dose is usually between 3 to 5 milligrams. However, the benefit “is just not there,” he adds.

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