Melatonin Overdoses in Children Prompt New Industry Guidelines

Melatonin Overdoses in Children Prompt New Industry Guidelines
(Joe Raedle/Getty Images)
Amie Dahnke
4/17/2024
Updated:
4/18/2024
0:00

In a bid to curb the alarming spike of young children accidentally overdosing on melatonin supplements, the Council for Responsible Nutrition (CRN) has adopted new voluntary guidelines for manufacturers.

This move comes just one month after the U.S. Centers for Disease Control and Prevention revealed that melatonin accounted for 7 percent of all emergency room visits for infants and toddlers related to unsupervised medication ingestion between 2019 and 2022.

Alarming Spike Toddler Melatonin ER Visits

Melatonin is a naturally occurring hormone produced by the body’s pineal gland. Its primary role is to help regulate the body’s sleep-wake cycle.

Typically, the body’s melatonin levels are low during the day, but they naturally rise after sunset. However, modern life, with its constant access to screens and digital devices, can disrupt this natural cycle, making it difficult for people to fall asleep. The screen’s blue light inhibits the production of melatonin.

In recent years, melatonin has become a widely used supplement, often taken to boost sleep support. The number of adults relying on the supplement has increased fivefold from 1999-2000 to 2017-2018, according to the CDC.

Concerningly, this surge in melatonin use has coincided with a 530 percent increase in poison center calls for pediatric melatonin exposures between 2012 and 2021, as well as a 420 percent spike in ER visits for unsupervised melatonin ingestion by infants and young children from 2009 to 2020.

Guidelines for Responsible Formulation and Labeling

The CRN has adopted two sets of voluntary guidelines for supplements containing melatonin.

Recommendations for dietary supplements

The CRN has adopted two sets of voluntary guidelines for supplements containing melatonin.

They suggest that manufacturers be transparent about melatonin dosages, especially for supplements containing high doses. Additionally, manufacturers should package melatonin supplements in child-deterrent packaging and include precautionary label statements warning consumers that the product contains melatonin.

“These guidelines are designed to ensure that consumers have access to products that are responsibly formulated, labeled and packaged,” the CRN wrote in a press release.

The U.S. Food and Drug Administration does not provide oversight for dietary supplements and has not made any dosage recommendations. However, the Institute of Medicine suggests, and CRN supports, that healthy adults use melatonin in short-term spurts at doses of 10 mg or less per day.

There is some evidence suggesting that higher melatonin levels may be helpful for some people. Nevertheless, experts recommend that a single serving of melatonin supplements should not exceed 10 mg, according to the Sleep Foundation.

Product labels should include statements indicating that melatonin is for occasional or intermittent use only, for adult use only, and that health care professionals should be consulted if a person experiences long-term sleep difficulties or is pregnant.

The CRN also suggests that product labels include warnings about melatonin’s potential to cause drowsiness, that it should not be mixed with alcohol, and that the supplements should be kept out of reach of children.

Recommendations for gummy supplements

Gummy form supplements should have targeted usage instructions for both children and adults, as well as a precautionary statement about the importance of chewing properly to avoid choking hazards, the CRN advised.

Gummy supplements should be packaged in child-safe containers to deter young children from inadvertently consuming them.

“By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers,” CRN President and CEO Steve Mister said.

The CRN is a 50-year-old organization based in Washington, D.C. It represents over 180 dietary supplement and food manufacturers, ingredient suppliers, and companies that provide services to those producers and suppliers.

Amie Dahnke is a freelance writer and editor residing in California. She has covered community journalism and health care news for nearly a decade, winning a California Newspaper Publishers Award for her work.