Melatonin is a hormone that is naturally produced by the brain. It regulates a person’s sleep cycle by producing more melatonin when it is dark, prompting sleepiness. Supplements can be found over the counter without a prescription and are often sold as gummies. Melatonin is considered a dietary supplement and isn’t regulated by the Food and Drug Administration as a form of medication.

Last year, the American Academy of Sleep Medicine issued a health advisory urging parents to consult a pediatrician before giving their children melatonin long-term. The American Academy of Pediatrics encouraged parents only to use melatonin as a short-term solution to help them establish a bedtime routine or reset their sleep schedule after school breaks and vacations. Most sleeping difficulties are “almost always behavioral in nature,” according to Boston Children’s Hospital.

The study published by JAMA Pediatrics indicated that little research has been done so far concerning the long-term safety of melatonin use by children.

It was also found that the melatonin found in supplements dramatically varies from the dosage indicated on the label. Some products contained over 300% of the amount of melatonin listed on the bottle, according to research published last April by JAMA. 

High doses of melatonin can lead to headaches, nausea, dry mouth, itchy skin and vivid dreams such as nightmares, Dr. Hal Alpert told USA Today. In some cases, it can also lead to rebound insomnia, depression, irritability and sedation that lasts into the next day.

The Sleep Foundation recommends a specific dosage for children. Preschoolers of age five should take one to two milligrams, children between the ages of six and 12 should take no more than three milligrams and teenagers under 18 should take no more than five.

The news also comes as the CDC reported a 530% increase in reports of melatonin to poison control centers between 2012 and 2021. Most incidents involved children under five, and 94% of cases were unintentional.