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Pediatric poisoning from the dietary supplement melatonin rose by over 500% from 2012 to 2021, mainly due to an increase among children under age 5, researchers found.

Children ingesting melatonin, which is generally used to treat insomnia and sleep disorders, accounted for 4.9% of all pediatric ingestions reported to poison control centers in 2021, a 530% jump from 0.6% in 2012, reported Karima Lelak, MD, of Children's Hospital of Michigan in Detroit, and colleagues.

In addition, pediatric hospitalizations related to melatonin poisoning rose during the study period. Five children required mechanical ventilation and two died, the authors wrote in the .

Lelak's team noted that not surprisingly, the largest increase in melatonin ingestion occurred during the COVID pandemic, writing that "this might be related to increased accessibility of melatonin ... as children spent more time at home because of stay-at-home orders and school closures," or that the pandemic might have increased sleep disturbances, which meant it was accessible in more households.

"Public health initiatives should focus on raising awareness of increasing numbers of melatonin ingestions among children and on the development of preventive measures to eliminate this risk," the researchers wrote.

The authors examined data from single-substance melatonin ingestions in individuals 19 or younger which were reported to U.S. poison control centers.

From 2012 to 2021, there were 260,435 pediatric melatonin ingestions reported, which comprised 2.25% of all pediatric ingestions. That number skyrocketed from 8,337 in 2012 to 52,263 in 2021, with the largest increase (+38%) occurring from 2019 to 2020.

Nearly all (94%) were unintentional, occurred in the home (99%), and managed on-site (88%). Most involved boys age 5 or younger.

A large majority (83%) of children were asymptomatic, though gastrointestinal, cardiovascular, and central nervous system symptoms were most common among symptomatic children.

However, 27,795 children required treatment at a healthcare facility. While most (72%) were discharged, 15% were hospitalized and 1% required intensive care. The majority of children who were hospitalized were teenagers with intentional ingestions. Lelak and co-authors added that 4,555 children (1.6%) who ingested melatonin had more serious outcomes.

The two deaths were among children ages 3 months and 13 months; both occurred in the home and one was due to "intentional medication misuse," the authors wrote.

The authors urged healthcare providers to warn parents about potential toxic consequences of melatonin exposure and to report any melatonin-related adverse events to FDA's MedWatch, the agency's medical product safety reporting program.

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