Council Urges Melatonin Makers to Adopt Safer Guidelines as Children Continue to Land in the Emergency Room

By: Amanda Kusumowidagdo | Published: Apr 26, 2024

Taking melatonin as a sleeping aid is probably not unusual. But when children who took melatonin start turning up in emergency rooms after an accidental intake of melatonin, something needs to be done.

Thankfully, the Council for Responsible Nutrition is on it. They are urging melatonin makers to adopt new voluntary packaging guidelines to promote “responsible use.” But will this move help?

Accidental Ingestion by Children

The Centers of Disease Control and Prevention reported 11,000 cases of infants and young children visiting the ER after accidentally ingesting melatonin between 2019 and 2022. 

Red Emergency sign on the front of a building

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President and CEO of the Council for Responsible Nutrition, Steve Mister, said that the uptick in accidental ingestions coincided with the increased sales of the supplements.

"Gummy" Capsules Attract Children

One might be wondering, “How could children accidentally ingest a hormone supplement?” The answer is all in the shape.

Assorted gummy candies in different colors

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Melatonin is commonly packaged like gummies, gelatinous candies often shaped like little bears or insects. These gummies might look attractive to infants and young children, who probably don’t realize what they’re ingesting is not a sugary treat, but a supplement to help with sleep.

Improperly Closed Bottles

Based on those ER visits recorded by the CDC, the health agency found that packaging might also be at fault.

A close-up of an opened bottle of pills spilling on a table

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Around three-quarters of cases involved children getting melatonin directly from the bottles or containers. This suggested that infants and children could open the bottles or that the bottles were not properly closed in the first place.

Be Careful With High Doses

Melatonin supplements are generally safe, with few side effects. But they mustn’t be taken in high doses.

A person wearing gloves pouring out blue jelly-like pills onto the palm of one hand

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Experts recommend taking no more than 10 mg of melatonin before sleeping. Preschool and school age children should take somewhere between 1 and 3 mg and no more. Consulting a doctor before giving melatonin to children is also recommended.

New Packaging

“There’s more melatonin out there and more kids seem to be getting into it,” Mister said. This situation drove the council to draft new guidelines as “an effort to demonstrate responsible behavior on behalf of the industry.”

Containers and bottles in different sizes on a white surface lit by sunlight

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The guidelines call for a new packaging that challenges children to open it, especially for flavored melatonin “candies.” These include gummies and chewables that would attract kids, who would easily mistake the form as candies or vitamins.


Aligned With CDC Report

The packaging guideline is aligned with the CDC report about open packaging or improperly closed packaging.

A gloved hand holding a pill bottle containing white pills in front of a yellow background

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“Melatonin products do not require child-resistant packaging, although such packaging can be voluntarily implemented. Selecting products with child-resistant packaging might be advisable in homes with young children,” the CDC stated.


Clear Labels

Another move recommended by the guidelines is writing labels that clearly warn of drowsiness. The label should also include a warning of not to take melatonin without adult supervision.

A black pictogram of warning sign of Keep Out of Reach of Children

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“Keep out of reach of children” is yet another warning that the label should put. And finally, the label should also say melatonin is only to be used occasionally.


Children Using Melatonin

Then, are parents wrong to give their children melatonin at all? Children with neurologic or neurodevelopmental problems may benefit from melatonin. Otherwise, parents are advised to find other ways to give their children sleep aid.

A woman looking at her mobile phone while sitting with her two children

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The American Academy of Sleep Medicine already issued a health advisory with warnings when melatonin use first went on the rise in 2022. Giving melatonin to help children sleep is clearly a last resort, to be taken only after a medical consultation.


Widespread Use of Melatonin

A recent research published in JAMA reported that 1 in 5 school age children and adolescents now take melatonin frequently.

A teenager wearing green T-shirt sleeping with a troubled expression

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University of Washington’s professor of pediatrics Dr. Cora Collette Breuner is worried about this widespread use. Because melatonin supplements are not strictly regulated by the U.S. Food and Drug Administration, getting it off the shelf is easy.


Unknown Future Effects

According to Breuner, melatonin is a hormone and it’s not the same as a vitamin. There’s still no real data on long-term frequent use in children. There’s a lack of research all around.

A trio of male adolescents standing by a wall

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There’s also no data for dosing by age and weight. There’s not even concrete data about when’s the best time to give melatonin and how much. “I don’t want families to think they should be able to do this for months at a time,” Breuner said.


One Step Further

So far, Breuner appreciates the steps taken by the council and the medical industry. But she thought they could go further: by removing the flavored forms of melatonin altogether and setting penalties for manufacturers that don’t follow the voluntary guidelines.

A girl sleeping in her bed surrounded by pillows and plushies with a softly lit lamp on the bedside

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Meanwhile, the Council for Responsible Nutrition expects its members to comply. After all, they voted for the guidelines themselves. And Breuner has one last suggestion for parents: “[Take] away blue-light-emitting smartphones, tablets, laptops and television at least two hours before bed” as this will keep melatonin production humming along.