Characteristics of Melatonin Use Among US Children and Adolescents

Abstract

This survey study describes parent-reported sleep practices, such as prevalence, frequency, and timing of melatonin use, among young people aged 1 to 13 years.

In a 2017-2018 study,¹ 1.3% of US parents reported that their children consumed melatonin in the past 30 days, and sales more than doubled between 2017 and 2020.² In the US, melatonin is considered a dietary supplement, is not regulated by the US Food and Drug Administration, and requires no prescription, raising particular concern because the amount of melatonin present in over-the-counter supplements can vary drastically. In a recent examination of 25 commercial supplements, actual melatonin quantity ranged from 74% to 347% of the labeled content.³ Additionally, incidence of melatonin ingestion reported to poison control centers increased 530% from 2012 to 2021,⁴ largely occurring among children younger than 5 years. Current data are lacking on the prevalence of melatonin use and the frequency, dosing, and timing of melatonin administration in US youth.

Methods

In this survey study, parents of children and adolescents aged 1.0 to 13.9 years completed an online questionnaire (REDCap; Vanderbilt University) on their children’s sleep-related practices, including any melatonin use in the past 30 days (eMethods in Supplement 1). The University of Colorado Boulder Institutional Review Board approved the study and waived the informed consent requirement because the research involved minimal risk. We followed the AAPOR reporting guideline.

Data were collected via convenience sampling between January and April 2023. Data were analyzed by age group: 1 to 4 years (preschool), 5 to 9 years (school aged), and 10 to 13 years (preteen). One-sided P < .05 indicated statistical significance. IBM SPSS Statistics 28.0 (IBM) was used to perform data analysis.

Results

Data were analyzed for 993 children and adolescents (524 females [52.8%], 460 males [46.3%]; mean [SD] age, 6.14 (3.50) years). 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%]) (Table). 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 (Figure). 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 was 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.

Table. Descriptive Statistics of Melatonin Prevalence and Administration Frequency, Dose, Timing, and Duration Across Age Groups (N = 993).

	Age group, y			χ2 Statistic	P value
	1-4: Preschool (n = 450)	5-9: School-aged (n = 368)	10-13: Preteen (n = 175)
Melatonin use in past 30 d, No. (%)	25 (5.6)	68 (18.5)	34 (19.4)	38.71 (n = 993)	<.01a
Melatonin descriptives, median (range)
Typical d/wk of melatonin use, No. of d	5 (0-7)	2 (0-7)	3 (0-7)	1.18 (n = 125)	.56
Melatonin dose, mg	0.5 (0.25-2.0)	1.0 (0.25-5.00)	2.0 (0.25-10.0)	34.73 (n = 120)	<.01a
Timing of melatonin administration before intended bedtime, min	30.0 (10.0-60.0)	30.0 (0.0-60.0)	30.0 (0.0-60.0)	0.33 (n = 127)	.85
Duration of melatonin use, mo	12.0 (1.0-30.0)	18.0 (0.0-66.0)	21.0 (0.0-108.0)	11.57 (n = 127)	<.01a

^a Exact P values were not provided by the statistical software.

Figure. Parent-Reported Mean Frequency of Melatonin Use Among Children and Adolescents in Past 30 Days (N = 125).

A parent responding less than 1 may have administered melatonin in the past 30 days due to an unusual circumstance (ie, traveling across time zones) but did not administer melatonin during a typical week.

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%).

Discussion

Results suggest that melatonin consumption by US children and adolescents is exceedingly common, with some parents beginning administration to their children at an early age. Melatonin forms and preparations are more child-friendly (eg, 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.

Except in autism,⁵ melatonin efficacy and dosing have not been established, and indications will likely vary across age groups. 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.⁶

Study limitations include the relatively small, convenience sample and size and homogeneity of the sample’s demographics. Additional large-scale studies are needed to determine the specific indications for melatonin and to examine the effectiveness and safety of long-term use in children and adolescents. Future work is needed to characterize the factors underlying parents’ decision to administer melatonin to their children.

Supplement 1.

eMethods

Supplement 2.

Data Sharing Statement