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Is melatonin safe?

A woman asleep in bed.

May 12, 2023—Melatonin supplements are increasingly used to treat sleep problems, but this over-the-counter option may have hidden risks.

Melatonin is a hormone that regulates the sleep/wake cycle. Melatonin supplements add to the levels of the hormone that your brain produces naturally. These supplements may help with certain sleep timing issues, such as jet lag, according to the National Center for Complementary and Integrative Health (NCCIH).

But when it comes to treating insomnia or coping with shift work, there's not enough evidence to show that melatonin supplements help, reports the NCCIH.

And melatonin supplements can come with serious safety concerns.

What you see may not be what you get

One reason to be cautious: When you take a melatonin supplement, you might not be getting the dose—or ingredients—on the label.

When researchers analyzed 25 brands of melatonin gummies, 22 were inaccurately labeled, according to a recent study in JAMA. One product didn't contain enough melatonin to be measured. The others had doses ranging from 74% to 347% of the amount on the label.

The researchers didn't find that the gummies they tested contained serotonin, a hormone that can be harmful. But according to NCCIH, a 2017 study of melatonin supplements found a similar mismatch between labels and contents. And in that study, 26% of supplements tested contained serotonin.

One reason for the discrepancies: Melatonin is regulated by the U.S. Food and Drug Administration as a dietary supplement, not as a drug. Regulations for supplements are not as strict.

Take extra care with kids

Short-term use of melatonin supplements appears to be safe for most people. But there hasn't been much research on children and melatonin. And because melatonin is a hormone, there is a chance that it may affect children as they develop or as they go through puberty. Ask your child's doctor for advice.

Another risk for kids and teens: Accidental overdose. As melatonin supplements have become more popular, more kids are accidentally consuming them. Accidental melatonin ingestions in kids increased 530% between 2012 and 2021, according to a report from the Centers for Disease Control and Prevention. In 2020, melatonin was the most frequent substance reported to national poison control centers.

In most cases, those overdoses did not lead to serious outcomes. But some children were hospitalized, and two died.

If you use melatonin supplements, make sure to store them out of reach of children.

Sleep safely

If you have trouble sleeping, the American Academy of Sleep Medicine recommends trying a few simple changes before taking melatonin. For instance, it may help to:

  • Keep a regular sleep schedule.
  • Create a relaxing bedtime routine.
  • Make your bedroom quiet and cool at night.
  • Avoid using screens for at least 30 minutes before going to sleep.
  • Avoid caffeine in the late afternoon or evening.

If changes like those aren't helping, talk to your doctor about what might be keeping you up at night. Together, you can make a well-informed decision about what's right for you.

If you use melatonin supplements, remember these guidelines:

  • Ask about interactions. Talk with your doctor about how melatonin might react with other medicines you take, especially if you take blood thinners or have epilepsy.
  • Watch for allergic reactions. Ask your doctor what signs to look out for.
  • Don't take it if you're pregnant or breastfeeding. There has not been enough research for this group on how melatonin might affect your pregnancy or baby.
  • Take care if you're older. Daytime drowsiness may be higher for older people. And people with dementia should not take melatonin.

Think you might have a sleep disorder? Take this quick assessment before you talk with your doctor.

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