Notes from the Field: Emergency Department Visits for Unsupervised Pediatric Melatonin Ingestion — United States, 2019–2022

Investigations and Outcomes

Data from the National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance Project were used to identify cases of ED visits for unsupervised melatonin ingestion by infants and children aged ≤5 years during 2019–2022, based on the treating clinician’s diagnosis and supporting documentation in the ED record.* Case narratives were used to code circumstances and details about ingested melatonin products. Cases were weighted to allow calculation of national estimates and corresponding 95% CIs. SAS software (version 9.4; SAS Institute) SURVEYMEANS was used to account for sample weights and complex sample design. This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.^†

Based on 295 cases, an estimated 10,930 ED visits (95% CI = 7,609–14,251) occurred for unsupervised melatonin ingestion by infants and children aged ≤5 years in the United States during 2019–2022 (Table), accounting for 7.1% of all ED visits for unsupervised medication exposures by persons in this age group. Approximately one half (52.4%) of all estimated ED visits for melatonin ingestion by infants and children aged ≤5 years involved children aged 3–5 years, and most (93.5%) did not result in hospitalization. Melatonin was the only medication involved in 90.2% of ED visits for melatonin ingestions.

A solid dosage form product was accessed by infants and children aged ≤5 years in 95.7% of ED visits for melatonin ingestions by persons in this age group. Gummy formulations (47.3%) were the most commonly documented dosage form; however, an unspecified solid formulation was documented in approximately one half (49.2%) of visits. Access to ≥10 units (e.g., gummies or tablets) was documented in more than one third (35.8%; 95% CI = 28.6%–43.0%) of visits for solid melatonin ingestions. Ingestion of adult or family formulations^§ of melatonin was documented in 47.7% of visits; however, intended age group of formulation was not specified in 45.0% of visits. At least 32.8% of infants and children accessed melatonin from a bottle; however, container type was not documented for 56.6% of visits.

Preliminary Conclusions and Actions

During 2019–2022, melatonin was implicated in 7% of all ED visits for unsupervised medication exposures by infants and young children. Few visits were found to result in hospitalization in this study. Similarly, a recent study of poison center calls found that 98% of pediatric melatonin exposures resulted in minimal or no effects and increases in hospitalizations for pediatric melatonin ingestion coincided with increased use (2). However, another recent investigation of melatonin products found that the actual content of the melatonin product was not always the same as the labeled ingredients or strength, and these discrepancies in ingredients or strength could pose additional risk.^¶

Approximately one half of visits for melatonin ingestions by infants and children aged ≤5 years involved children aged 3–5 years, whereas most visits for unsupervised medication exposures overall involve infants and children aged 1–2 years (3). At least half of ED visits for melatonin ingestions involved flavored products (gummies or chewable tablets) that are frequently used by (4) and might appeal to young children.

Melatonin products do not require child-resistant packaging,** although such packaging can be voluntarily implemented. Among ED visits with documentation of container type, approximately three quarters involved melatonin accessed from bottles, suggesting that infants and children opened bottles or that bottles were not properly closed. Selecting products with child-resistant packaging might be advisable in homes with young children.

Surveillance data have limitations. Analyzing only cases resulting in ED visits likely underestimates overall melatonin ingestions by infants and young children. Detailed narrative information was not always documented; therefore, misclassification might occur, and involvement of specific product types or circumstances might be higher than reported.

The occurrence of approximately 11,000 ED visits for unsupervised melatonin ingestions by infants and young children during 2019–2022 highlights the continued need to educate parents and other caregivers about the importance of keeping all medications and supplements (including gummies) out of children’s reach and sight (5). The Up and Away Campaign^†† is an initiative led by CDC in collaboration with other government and nongovernmental partners to educate families about the importance of safe medicine storage around young children.