Overall melatonin use is relatively low among U.S. adults. However, by 2017–2018, the percentage of adults taking more than 5 milligrams of melatonin a day had more than tripled compared to a decade earlier, according to a recent study.
And according to the Centers for Disease Control and Prevention, the number of children taking melatonin—whether by accident or on purpose—increased by 530% from 2012 to 2021, with more than 260,000 ingestions reported.
More pediatric hospitalizations and serious outcomes have been reported, mostly because of an increase in unintentional melatonin ingestions in children under the age of five. At least 27,795 children required medical care over the course of the decade, while two children died.
How Does Melatonin Work?
Melatonin is a hormone that helps us fall asleep faster. It’s naturally produced by the brain’s pineal gland and it’s made from the amino acid tryptophan and the neurotransmitter serotonin, according to Jeff Gladd, MD, an integrative medicine physician and the chief medical officer at Fullscript.
Our melatonin levels decrease when we are exposed to light and increase when our eyes are exposed to diminishing light, Gladd said, and the hormone plays a crucial role in regulating our sleep-wake cycles (also known as our circadian rhythm).
Melatonin supplements are sold over-the-counter in the U.S. in doses as low as 0.3 mg to as high as 60 mg. They are said to help with certain conditions such as jet lag, delayed sleep-wake phase disorder, and anxiety before and after surgery, though many Americans use it nightly to treat chronic insomnia.
But the American Academy of Sleep Medicine concluded that there’s not enough strong evidence on the effectiveness or safety of melatonin for chronic insomnia to recommend its use. Still, many people believe melatonin is completely safe since it’s a hormone our bodies naturally produce, though this isn’t exactly true.
“The perception of melatonin as natural can create a false sense of safety, meaning people end up taking it incorrectly as a sleeping pill,” Ruby Deubry, RPh, BCMTMS, registered pharmacist at Persona Nutrition, told Verywell. “Melatonin is actually not a very potent hypnotic and may only help with certain sleep disturbances.”
Though pure melatonin is a natural hormone, Deubry explained that the oral doses people take are sometimes considerably more than what the body would produce, and a poor-quality melatonin product could contain impurities that are far from natural.
OTC vs. Prescription Melatonin
Unlike in many European countries, Japan, Australia, and the United Kingdom—where a prescription is required to access the product—melatonin is sold as an OTC supplement in the U.S.
Since supplements are classified as food by the Food and Drug Administration (FDA), they aren’t subject to the same strict federal regulations as prescription drugs, meaning they’re more likely to contain additives.
In the U.S., according to Deubry, the FDA will only mark a product as OTC if there’s a certain level of evidence that the product is effective, meets an acceptable safety margin, has low misuse potential, and can be self-managed by the public.
“For the most part, melatonin checks all these boxes,” Deubry said. “This OTC classification could shift though as the use of melatonin dramatically increases.”
Melatonin Isn’t Risk Free
Melatonin is considered fairly safe for short-term use, but it’s not recommended for people who are pregnant or breastfeeding, or people with dementia. Those who regularly consume melatonin have reported some mild adverse effects, according to Gladd, including dizziness, headaches, nausea, and drowsiness.
Gladd added that the long-term safety data when it comes to taking high doses of melatonin—especially for children and adolescents—is sorely lacking and needs to be investigated further.
“High doses of melatonin may increase the risk of side effects including headache, vivid dreams, mood disturbances, and stomach upset,” Deubry said. “Daytime sleepiness is also possible and can lead to a disruption in the circadian rhythm, which is the opposite of what we want. Although there are no clinical studies that establish how long melatonin should be used, it’s best to limit it to the short term.”
Like with any supplement or medication, Gladd said it’s important that people consult with their healthcare provider prior to starting melatonin to make sure it’s the right supplement for them and to develop a plan to work on other aspects of quality sleep to ensure the use of melatonin is temporary.
How to Sleep Better
To avoid relying on sleep aids like melatonin for an extended period of time, Gladd recommends incorporating a variety of sleep hygiene practices into your daily routine.
The first is to be consistent with your sleep and wake times, and he suggests setting a daily bedtime and morning alarm as a first step. Exercise can also be a helpful tool for improving sleep in both healthy people and those with sleep disorders, he said.
“Light will disrupt melatonin production, so keep your bedroom as dark as possible, use a sleep mask, and consider blackout curtains,” he said.
He also suggested limiting your exposure to blue light from electronic devices at night.
“Try to avoid the use of your computer, TV, phone, or tablet three hours before bed. If your bedroom is noisy at night, consider sound-masking strategies like a white noise machine, or a fan,” Gladd said. “Finally, if you tend to overheat at night, consider a bath or footbath to optimize skin temperature and comfort prior to going to bed.”
