New guidelines aim to make melatonin safer for kids

A leading trade group is asking companies that make melatonin to voluntarily adopt child-deterrent packaging and other improvements to how their products are packaged and labeled.

Melatonin is a hormone that is widely used as a sleep aid. In recent years, approximately 11,000 infants and young children have visited the emergency room after accidentally taking melatonin, the Centers for Disease Control and Prevention reported last month.

This increase in accidental ingestions has coincided with increased sales of melatonin, says Steve Mister, president and CEO of the Council for Responsible Nutrition, the trade association which released the new guidelines.

"There's more melatonin out there and more kids seem to be getting into it," Mister says. He says the group drafted the guidelines "as an effort to demonstrate responsible behavior on behalf of the industry."

The guidelines call for packaging that's harder for young kids to open, specifically for melatonin sold in flavored form. That includes gummies or chewables that might be appealing to kids, especially little ones who might think it's candy or even vitamins.

The guidelines also recommend labels that clearly warn that melatonin can cause drowsiness, should only be used with adult supervision and should be kept out of the reach of children. The labels should also stress that melatonin is only meant for occasional use. That's a point many pediatricians have been making – especially because many kids and teens are now intentionally taking melatonin as a sleep aid.

"I really applaud the industry for responding to our concerns. It's a great start," says Dr. Cora Collette Breuner, a professor of pediatrics at the University of Washington.

However, Breuner would like to see the industry go further, by doing away with flavored forms of melatonin altogether and establishing consequences for manufacturers that don't adopt the voluntary guidelines. The Council for Responsible Nutrition says it expects its members will comply because they voted for the guidelines themselves.

Recent research shows nearly 1 in 5 school-age children and adolescents are now using melatonin on a regular basis.

Breuner is among pediatricians who worry about such widespread use, for several reasons. For starters, melatonin supplements aren't regulated with the same rigor as prescriptions and over-the-counter medications. She says because melatonin is easy to find on store shelves, people assume it's just as safe as taking a vitamin. But melatonin is a hormone, and she says there's no real data on long-term use in children. Breuner notes there are also no guidelines for dosing by age and weight, or when to give melatonin and how much.

Given the lack of research, Breuner says, "I don't want families to think they should be able to do this for months at a time."

It's possible for kids to overdose on melatonin, which can lead to symptoms including severe headaches, dizziness, stomach pains, extreme drowsiness – even bedwetting. Pediatric overdoses of melatonin have skyrocketed in recent years, jumping more than 500% between 2012 and 2021. While most kids were treated at home, hospitalizations also went up, and two children died during that time period, according to research published by the Centers for Disease Control and Prevention.

Dr. Nia Heard-Garris is a researcher at Northwestern University and a pediatrician at Lurie Children's Hospital of Chicago. She says parents should definitely talk to their kids' pediatricians before giving them melatonin – especially if they're considering using it in the youngest kids, like preschoolers, because it's easy to give them too much.

She says even in older kids, melatonin use should just be very occasional. But that should also prompt a talk with your kid's pediatrician, she says, because "occasional" can be subjective.

"You tell me that you're using it three times a week, and I'm like, that's more than I want you to be using it," Heard-Garris says. "What's going on? You know, let's talk through what's happening, and then we can kind of get to the root of the problem. If it's once a year, once every four or five months, maybe that's less of a red flag."

Breuner notes that teens often self-administer melatonin, but parents should be supervising them, too, because in her practice, she's had teen patients report taking two or three times the recommended dose when they didn't feel an effect right away.

While it's OK to use melatonin as a short-term way to help kids get rest, Breuner and Heard-Garris agree that the focus needs to be on sleep hygiene first. That means doing things such as turning off screens at least an hour before bedtime, using blackout shades and noise canceling machines or earplugs, and not letting kids stay up more than an hour or two past their normal bedtime on weekends and vacations.

If a parent does decide to give their child melatonin after consulting their doctor, Breuner recommends that they use the lowest dose possible and look for a label that indicates the product has been tested by a third party, such as the NSF or the U.S. Pharmacopeia – to ensure that the supplement contains what the label says.

Studies have found some supplements – including gummies – can contain much more melatonin than what's listed on the label, though the industry has disputed the methodology used in those findings.

This story was edited by Jane Greenhalgh