American Academy of Sleep Medicine
Health Advisory: Melatonin Use in Children and Adolescents
Melatonin is a natural hormone that helps us regulate our own sleep timing. Even though our body makes its melatonin in the brain, some people use extra melatonin to improve their sleep. Melatonin can improve sleep in children whose body clocks are “off schedule” and in some children with developmental problems.
Melatonin use has increased in the last two decades across all ages.3 Melatonin is the secondmost popular “natural” product that parents give to their children, next to multivitamins. With this increased use, there are growing reports of melatonin overdose, calls to poison control centers, and emergency room visits for children, even more so during the COVID-19 pandemic.
Parents should talk to a health care professional before giving melatonin or any supplement to children. 6 Be aware that in the U.S., melatonin is considered a “dietary supplement.” Melatonin is not under FDA oversight like other over-the-counter (OTC) or prescription medications. Melatonin content in supplements can vary widely. In one study, melatonin ranged from less than one-half to more than four times the amount stated on the label. The most significant variability in melatonin content was in chewable tablets - the form children are most likely to use. Some products even contained other chemicals that need medical prescriptions.
To address the safe use of melatonin in children and teens, we advise that: 1. Melatonin should be handled as any other medication and kept out of reach of children. 2. Before starting melatonin or any supplement in their children, parents should discuss this decision with a pediatric health care professional. Many sleep problems can be better managed with a change in schedules, habits, or behaviors rather than taking melatonin. 3. If melatonin is used, the health care professional can recommend the melatonin dose and timing for the sleep problem. Parents should select a product with the USP Verified Mark to allow for safer use...
A USP Verified Mark indicates the supplement was produced in a facility that followed the FDA's Good Manufacturing Practice standards.
"These products meet some product quality control measures, including containing the amount of an ingredient on the label without harmful levels of specific contaminants," the AASM wrote. "However, this is a voluntary program, and only four melatonin products, all with either 3 mg or 5 mg of melatonin, have received the USP Verified Mark."
The American Academy of Sleep Medicine (AASM) issued a health advisory Wednesday encouraging parents to seek medical advice before giving melatonin or any supplement to children.
"While melatonin can be useful in treating certain sleep-wake disorders like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster," M. Adeel Rishi, MD, MBBS, of Indiana University Health Physicians in Indianapolis and vice chair of the AASM Public Safety Committee, said in a statement.
"Instead of turning to melatonin, parents should work on encouraging their children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches," he added.
The advisory comes on the heels of a report published by the CDC indicating that reported pediatric poisonings from melatonin jumped by over 500% from 2012 to 2021.
In that period, 260,435 pediatric melatonin ingestions were reported to poison control centers. The number skyrocketed from 8,337 in 2012 to 52,263 in 2021, with the largest increase occurring from 2019 to 2020.
Nearly all ingestions were unintentional, occurred in the home, and managed on-site. Most involved boys ages 5 and younger.
Symptoms of melatonin overdose can include headache, dizziness, and irritability. Most children were asymptomatic, but 27,795 children required treatment at a healthcare facility. While most were discharged, 4,097 children were hospitalized and 287 required intensive care. Five children required mechanical ventilation, and two died.
Other pediatric research showed that, during the COVID-19 pandemic, melatonin supplanted analgesics as the most frequently ingested substance reported to U.S. poison control centers.
Melatonin is the second most popular "natural" product that parents give to their children, next to multivitamins, the AASM said.
"Be aware that in the U.S., melatonin is considered a dietary supplement," the group wrote in its advisory. This means that melatonin is not under FDA oversight like over-the-counter or prescription medications.
It also means the melatonin content in supplements may be inconsistent. A study of 30 commercial supplements showed that melatonin ranged from less than one-half to more than four times the amount stated on the label. Some products contained other substances that require medical prescriptions.
The most significant variability in melatonin content was in chewable tablets, the AASM cautioned. "The availability of melatonin as gummies or chewable tablets makes it more tempting to give to children and more likely for them to overdose," Rishi said.
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