The research letter in the Journal of the American Medical Association Pediatrics noted that in the U.S., melatonin is not regulated by the FDA and requires no prescription. It is readily available OTC at pharmacies, other retailers, as well as online.
University of Colorado at Boulder researchers and colleagues suggested that is especially concerning because the amount of melatonin present in OTC supplements can vary drastically.
They pointed out that, in a recent examination of 25 commercial supplements, actual melatonin quantity ranged from 74% to 347% of the labeled content. “Additionally, the incidence of melatonin ingestion reported to poison control centers increased 530% from 2012 to 2021, largely occurring among children younger than 5 years,” the authors explained. “Current data are lacking on the prevalence of melatonin use and the frequency, dosing, and timing of melatonin administration in U.S. youth.”
The study team surveyed parents of children and adolescents aged 1.0 to 13.9 years, asking them to complete an online questionnaire (REDCap; Vanderbilt University) on their children’s sleep-related practices, including any melatonin use in the past 30 days.
Data were collected via convenience sampling between January 2023 and April 2023 and analyzed by age group: 1 to 4 years (preschool), 5 to 9 years (school-aged), and 10 to 13 years (preteen). The analyses included 993 children and adolescents; 52.8% were female, and the mean age was 6.14 years.
The results indicated that the prevalence of melatonin consumption in the past 30 days was significantly higher for school-aged children (68 [18.5%]) and preteens (34 [19.4%]) than preschool children (25 [5.6%]), the study pointed out. “However, frequency of mean melatonin use during the past 30 days did not differ significantly across age groups. We observed a bimodal distribution of frequency, in which melatonin was most often administered either 1 or 7 days per week.”
The survey revealed that melatonin dose increased significantly across age groups, from a median (range) of 0.5 (0.25-2.0) mg in preschool children to 2 (0.25-10.0) mg in preteens. Timing of melatonin administration also was found to be highly consistent across age groups, with a median (range) of 30 (10.0-60.0) minutes before bedtime in preschool children to 30.0 (0.0-60.0) minutes in preteens.
“Preschool children who consumed melatonin in the past 30 days did so for a median (range) length of 12.0 (1.0-30.0) months. This duration increased to 18.0 (0.0-66.0) months for school-aged children and 21.0 (0.0-108.0) months for preteens. Across all groups, the most common form of melatonin use was gummy (64.3%), followed by chewable tablet (27.0%), pill (6.3%), and liquid (2.4%),” according to the report.
Study authors called melatonin consumption by U.S. children and adolescents “exceedingly common, with some parents beginning administration to their children at an early age. Melatonin forms and preparations are more child-friendly (e.g., gummies), which may be factors in increased use. Furthermore, parents reported administering melatonin for an extended period (often >12 months). Research is lacking on the long-term safety of melatonin in this population.”
The authors pointed out that except in autism, melatonin efficacy and dosing have not been established, and indications will likely vary across age groups.
They added, “Widespread melatonin use across developmental stages may suggest a high prevalence of sleep disruption, which deserves accurate diagnosis and effective treatment. Dissemination of information regarding safety concerns, such as overdose and supplement mislabeling, is necessary. Clinicians should discuss with parents the factors associated with sleep difficulties and effective behavioral strategies.”
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