A new study by the FDA has found that only half of melatonin products contain the actual dosage listed on the packaging, and many products marketed for children have much higher amounts.

Experts say that the safest way for children to take melatonin is to use third-party tested products for a short period under the guidance of a pediatrician.

Experts also emphasize that in addition to taking sleep aids, there are other methods to help children fall asleep, such as establishing a bedtime routine and limiting screen time before bed.

It is estimated that the use of melatonin among children is increasing, with almost one in five school-age children taking melatonin to fall asleep.

However, a new study conducted by researchers at the U.S. Food and Drug Administration has found that many products marketed for children contain much more melatonin than what is shown on the packaging.

Dr. Sham Singh, a sleep specialist and psychiatrist at the WINIT Clinic, told Health magazine: "This study serves as a wake-up call for the development of much-needed regulations on standard testing of supplements to ensure that the labels of pediatric products are accurate and safe."

This study builds on previous research findings, including small-scale studies in 2017 and 2023, which found that the tested labels of most melatonin supplements for children and adults were inaccurate.

Here is additional information about this new study, whether experts think children should use melatonin to help them sleep, and how to help your child fall asleep without using sleep aids.

Melatonin is a hormone that tells the body it's time to sleep. The pineal gland, located in the middle of the brain, secretes more melatonin when it's dark and less when it's light.

Melatonin is also sold as a sleep aid online and in pharmacies. It comes in various forms, from tablets and capsules to liquids and gummies.

As a supplement, melatonin is largely unregulated by the FDA. This means there is no guarantee to the public that it is effective, will not interact with medications, or even that it contains the ingredients listed on the label.

A spokesperson for the FDA told Health magazine that the increase in children's use of melatonin prompted the agency to conduct "additional research to better understand the market."

To conduct this study, researchers purchased melatonin products from Walgreens, CVS, Walmart, Target, GNC, or Amazon between May and September 2023. Most of the products (54%) were gummies, followed by tablets and liquids. 70% of these products were marketed for children, and the researchers tested them to assess the actual amount of melatonin they contained.

The researchers' findings were eye-opening: only half of the products contained the amount of melatonin recommended on the packaging, and two products did not contain melatonin at all.

Even more concerning, some products had much higher levels of melatonin than advertised - one sample had up to 667% of the labeled dose. While the average dose of 1.7 milligrams (mg) per serving is within the safe intake range for children, the highest dose tested - 50 mg per serving - far exceeds the recommended dose for children, which the American Academy of Pediatrics recommends as 0.5 to 6 mg.

Given the variation in melatonin doses among different products, experts advise parents to proceed with caution. The FDA spokesperson recommends that people consult a doctor, pharmacist, or other healthcare professional before giving dietary supplements to their children.

If parents decide to give melatonin to their children, experts recommend limiting the duration of use.

Singh said that although experts have long recommended "the cautious use of melatonin only under the guidance of a pediatrician as a short-term adjunct treatment for children with specific sleep disorders," studies show that many parents give melatonin to their children for 12 to 21 months or even longer.

Dr. Michelle Caraballo, a pediatric pulmonology and sleep medicine specialist at Children's Health in Dallas and an associate professor at the University of Texas Southwestern Medical Center, told Health magazine: "There is not enough information to support the safety of long-term use."

Parents who want to give melatonin to their children should choose products from reputable and independently tested companies. Seals from third-party companies such as the United States Pharmacopeia and Consumerlab.com indicate that the supplement has been tested for identity and purity.

However, "while there may be more trustworthy or accurate brands, even these cannot be 100% guaranteed to contain exactly the amount reported in their products without oversight," Caraballo said.

Caraballo also said that when using melatonin as a sleep aid, it is important to watch for signs of overdose in children. Short-term side effects may include:

Dizziness
Headache
Increased enuresis
Irritability
Low blood pressure
Nausea

Singh said that these latest findings may prompt healthcare professionals to place more emphasis on non-pharmacological methods of treating sleep disorders rather than using melatonin.

Whether or not you choose to give melatonin to your child, good "sleep hygiene" - a bedtime routine - is very important for helping children fall asleep faster. "Make sure the room where the child sleeps is a little cooler and that there are no extra lights on," Caraballo said. If they are old enough, try to avoid daytime naps for the child, and it is best to have dinner at least two hours before bedtime.

"In addition to these suggestions, establishing a bedtime routine and limiting the use of electronics before bed helps children strengthen their circadian rhythms," Caraballo said. Singh recommends replacing screen time with relaxing activities such as reading or listening to soothing music.