Melatonin may help sleep, but dosing and product quality pose risks

Melatonin can help some children and adults fall asleep sooner, but incorrect use and unreliable supplement labeling can cause real harm, according to Sally Ibrahim, a pediatrician and sleep medicine physician writing in The Conversation. The issue matters for families because U.S. regulators treat melatonin as a dietary supplement, leaving parents to choose products and doses in a crowded market.

Ibrahim wrote that melatonin is one of the best-studied sleep aids in children, even though the Food and Drug Administration has not approved insomnia medications for pediatric use. She said many families try to handle sleep problems for months or years before seeking specialty care, often after finding online advice that may not fit a child’s age or sleep condition.

How melatonin works

According to Ibrahim, the body releases melatonin in the evening from the pineal gland, a small endocrine gland in the brain. Levels rise overnight, peak in the middle of the night and fall by morning, she wrote.

Ibrahim said light suppresses melatonin production, while darkness allows release of the hormone. That is why sleep specialists often recommend limiting bright light at night and getting natural light during the day, especially in the morning, to support the body’s circadian rhythm, she wrote.

Melatonin differs from many over-the-counter sleep aids because it can both increase sleepiness and help shift the timing of the sleep-wake cycle, according to Ibrahim. She said it may be useful for insomnia and for delayed sleep-wake phase, a circadian rhythm disorder seen in some teens and young adults who do not feel tired until late at night.

Taking synthetic melatonin does not interfere with the body’s own melatonin production, according to research cited by Ibrahim. She said doctors commonly recommend taking it 30 minutes before bedtime when it is being used for insomnia.

Benefits and limits

Melatonin products come in immediate-release forms, often liquids or chewables, and extended-release forms, Ibrahim wrote. Immediate-release products typically peak within 10 to 30 minutes and are aimed at helping people fall asleep, while extended-release products act more gradually and may help people stay asleep, she said.

Studies cited by Ibrahim found mixed but meaningful benefits in children. One review found that many children with bedtime insomnia who take melatonin fall asleep faster and sleep about 30 minutes longer, though some children do not respond.

Evidence is strongest for children with neurodevelopmental disorders such as autism spectrum disorder and attention-deficit/hyperactivity disorder, according to Ibrahim. In one randomized trial of 125 children and teens, most of whom had autism, melatonin increased nighttime sleep by nearly 60 minutes, she wrote. Another study of 275 children found an average gain of 22 minutes compared with placebo.

Ibrahim said long-term evidence remains limited. She cited one two-year study of children with autism who took nightly prolonged-release melatonin and found no significant changes in body mass index or puberty timing.

Labeling problems and overdose concerns

The main safety concern in the United States is product inconsistency, Ibrahim wrote. Because melatonin is sold as a supplement rather than regulated as a prescription drug, one brand may match its label while another may contain far more, far less or other ingredients, she said.

A 2023 study cited by Ibrahim found that some products labeled as melatonin gummies contained no melatonin, while some contained cannabidiol, or CBD. Another analysis of 30 commercial melatonin products found melatonin levels ranging from 83% below to 478% above the labeled amount, with variation within a single lot reaching 465%, she wrote.

High doses in children have not been fully tested for safety, according to Ibrahim. The Centers for Disease Control and Prevention has reported that many pediatric overdoses involve mild symptoms, but some children have been hospitalized.

Ibrahim urged parents to keep melatonin, especially gummies, out of children’s reach because children may mistake them for candy. She also advised families to consult a health care professional before using melatonin or giving it to a child, and to consider reliable brands, including products with third-party verification such as USP.

Suggested pediatric doses

The International Pediatric Sleep Association recommends age-based limits, according to Ibrahim:

• Toddlers ages 2 to 3: up to 1 milligram; not recommended for infants under 2.
• Preschool children ages 4 to 5: up to 2 milligrams.
• School-age children ages 6 to 10: up to 3 milligrams.
• Older school-age children and adolescents ages 11 and up: up to 5 milligrams.

Ibrahim wrote that melatonin can be safe and useful when families use the right product, dose and timing for the right sleep problem, with guidance from a clinician.

This story draws on original reporting from Medical Xpress.