Abstract
This cross-sectional study examines subjectively and objectively assessed sleep and melatonin use in children.
Sleep problems are reported in 25% of children and adolescents.1 Melatonin is available in many countries without a prescription and is often considered a pharmacologic strategy to treat sleep problems. However, no clinical guidelines are available, and effectiveness and long-term effects of melatonin use in children are largely unknown.1 Melatonin use has been estimated to be 1% in healthy children. Little is known about the association of objectively measured sleep with melatonin use in this population. We investigated melatonin use in school-aged children and its association with subjective sleep and objectively estimated sleep parameters.
Methods
This cross-sectional study included children from the Generation R Study, a birth cohort representative of the general population in the Netherlands.2 The Medical Ethics Committee of the Erasmus University Medical Center approved all study procedures, and all parents provided written informed consent. Primary caregivers indicated children’s use of sleep medication (type and frequency throughout 6 months) when children were aged 11 years. Sleep problems were reported by the primary caregiver using the Child Behavior Checklist for Ages 6-18 (5 items) and by the child using the Sleep Disturbance Scale for Children (6 items) when children were aged 10 years.3 At age 11 years, total sleep time, sleep onset latency, and wake after sleep onset were estimated with a sleep diary and triaxial wrist accelerometer (GENEActiv; Activinsights; R-package GGIR4). The study procedure has been described previously.5 Briefly, the prevalence of caregiver-reported melatonin use was determined first. Second, associations of sleep with melatonin use were assessed with logistic regression analyses, adjusted for appropriate confounders. Missing data for confounders were imputed. As melatonin use has been proposed particularly for children diagnosed as having attention-deficit/hyperactivity disorder and autism spectrum disorder, we repeated analyses excluding children with these diagnoses. A threshold of 2-sided P = .005 was used to correct for multiple testing. Analyses were conducted in SPSS version 24 (IBM Corporation).
Results
A total of 871 children (mean [SD] age, 11.7 [0.2] years; 457 girls [52.2%]; 774 individuals [88.8%] were ethnically Dutch or of other Western European ethnicities; Table 1) were included in this study. Of 871 children, 53 (6.1%) used melatonin at least once a week in the previous 6 months. Caregiver- and child-reported sleep problems were associated with more melatonin use (Table 2). No other associations were observed after multiple testing correction (P = .005; Table 2). Results did not differ between week and weekend sleep and remained largely unchanged when excluding children with attention-deficit/hyperactivity disorder or autism spectrum disorder (n = 15), except that sleep diary–estimated total sleep time was now associated with melatonin use.
Table 1. Sample Characteristics.
| Characteristic | Mean (SD) | |
|---|---|---|
| Melatonin Use (n = 53) | No Melatonin Use (n = 818) | |
| Female, No. (%) | 22 (41.5) | 435 (53.2) |
| Age, y | 11.69 (0.18) | 11.67 (0.20) |
| Gestational age, wk | 39.51 (2.22) | 39.55 (2.36) |
| Ethnicity, No. (%) | ||
| Dutch | 46 (86.8) | 677 (82.8) |
| Western Europe | 1 (1.9) | 50 (6.1) |
| Non–Western Europe | 6 (11.3) | 90 (11.0) |
| ASD, No. (%) | 5 (9.4) | 4 (0.5) |
| ADHD, No. (%) | 3 (5.7) | 8 (1.0) |
| Caregiver | ||
| Age, y | 31.80 (3.61) | 32.32 (3.83) |
| Education, No. (%)a | ||
| Low | 3 (5.7) | 16 (1.7) |
| Intermediate | 17 (32.1) | 257 (31.4) |
| High | 32 (60.4) | 519 (63.4) |
| Depressive symptoms score, mean (range) | 0.22 (0-2.67) | 0.17 (0-3.50) |
| Subjectively assessed sleep problems score, mean (range) | ||
| Self-reported | 12.20 (8.00-18.00) | 11.00 (6.00-18.00) |
| Caregiver-reported | 2.04 (0.00-8.00) | 0.83 (0.00-7.00) |
| Sleep diary | ||
| Total sleep time, h:min | 9:18 (0:42) | 9:30 (0:51) |
| No. of times a child woke after sleep onset | 0.6 (0.5) | 0.6 (0.7) |
| Sleep onset latency, min | 31 (30) | 27 (21) |
| Objectively assessed sleep, h:min | ||
| Total sleep time | 7:30 (0:47) | 7:42 (0:42) |
| Wake after sleep onset | 0:30 (0:02) | 0:32 (0:02) |
| Sleep onset latency | 1:06 (0:52) | 0:54 (0:40) |
| Midpoint sleep on school days | 2:45 (0:36) | 02:40 (0:35) |
Abbreviations: ADHD, attention-deficit/hyperactivity disorder; ASD, autism spectrum disorder.
Low indicates primary school or lower vocational education; intermediate, intermediate vocational education; high, higher vocational education and university.
Table 2. Associations of Subjective and Objective Sleep Problems With Melatonin Use.
| Variable | Melatonin Use | |||
|---|---|---|---|---|
| Inclusion of Individuals With ASD and ADHDa | Exclusion of Individuals With ASD and ADHDb | |||
| OR (95% CI) | P Value | OR (95% CI) | P Value | |
| Subjectively Assessed Sleepc | ||||
| Sleep problems | ||||
| Caregiver-reported | 1.70 (1.41-2.05) | <.001 | 1.68 (1.38-2.05) | <.001 |
| Self-reported | 1.25 (1.10-1.42) | <.001 | 1.25 (1.09-1.43) | <.001 |
| Sleep diary | ||||
| Total sleep time, h | 0.63 (0.42-0.93) | .02 | 0.55 (0.37-0.81) | .005 |
| No. of times a child woke after sleep onset | 0.94 (0.61-1.43) | .76 | 0.86 (0.53-1.42) | .56 |
| Sleep onset latency, min | 1.01 (1.01-1.02) | .08 | 1.01 (1.01-1.02) | .03 |
| Objectively Assessed Sleepc | ||||
| Total sleep time, h | 0.65 (0.44-0.98) | .04 | 0.63 (0.42-0.96) | .03 |
| Wake after sleep onset, min | 0.98 (0.87-1.10) | .66 | 0.97 (0.89-1.06) | .60 |
| Sleep onset latency, min | 1.62 (1.09-2.41) | .02 | 1.68 (1.12-2.54) | .01 |
| Midpoint sleep on school days, h | 1.35 (0.82-2.45) | .24 | 1.53 (0.90-2.59) | .11 |
Abbreviations: ADHD, attention-deficit/hyperactivity disorder; ASD, autism spectrum disorder; OR, odds ratio.
There were 824 individuals included for subjective sleep measures and 871 for objective sleep measures.
There were 811 individuals included for subjective sleep measures and 856 for objective sleep measures.
Adjusted for child’s sex, age at behavior assessment, gestational age, and ethnicity as well as maternal age at birth, education, and psychopathology.
Discussion
This study estimated a prevalence of 6% of melatonin use in school-aged children, indicating that 1 in 17 children is likely to take melatonin at least once a week. This is despite the unknown effects of the use of melatonin in children.1
We found that caregiver- and child-reported sleep problems and sleep diary–reported shorter total sleep time were associated with melatonin use. The most likely explanation for our findings is that perceived poor sleep is an indication for melatonin use. Indeed, a previous study indicates that parents administer over-the-counter melatonin in 12-year-old children to improve sleep problems.1 However, melatonin is often taken without prescription or good advice on dosage and timing of administration. If melatonin is taken wrongly, for example by administering it shortly before bedtime, it can actually worsen sleep.6 However, the current study is cross sectional, precluding any inference about temporality.
The use of melatonin in school-aged children is common, although potentially harmful effects of melatonin use in children are unknown. Longitudinal and well-controlled studies are urgently needed to identify the effectiveness and potential negative consequences of melatonin use in children. This would provide the evidence to formulate clinical guidelines for the indication and dosage of melatonin in children, which is pressing issue as melatonin is currently freely available.
References
- 1.Janjua I, Goldman RD. Sleep-related melatonin use in healthy children. Can Fam Physician. 2016;62(4):315-317. [PMC free article] [PubMed] [Google Scholar]
- 2.Kooijman MN, Kruithof CJ, van Duijn CM, et al. The Generation R Study: design and cohort update 2017. Eur J Epidemiol. 2016;31(12):1243-1264. doi: 10.1007/s10654-016-0224-9 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Bruni O, Ottaviano S, Guidetti V, et al. The Sleep Disturbance Scale for Children (SDSC): construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996;5(4):251-261. doi: 10.1111/j.1365-2869.1996.00251.x [DOI] [PubMed] [Google Scholar]
- 4.van Hees VT, Sabia S, Anderson KN, et al. A novel, open access method to assess sleep duration using a wrist-worn accelerometer. PLoS One. 2015;10(11):e0142533. doi: 10.1371/journal.pone.0142533 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Koopman-Verhoeff ME, Bolhuis K, Cecil CAM, et al. During day and night: Childhood psychotic experiences and objective and subjective sleep problems. Schizophr Res. 2019;206:127-134. [DOI] [PubMed] [Google Scholar]
- 6.Bruni O, Alonso-Alconada D, Besag F, et al. Current role of melatonin in pediatric neurology: clinical recommendations. Eur J Paediatr Neurol. 2015;19(2):122-133. doi: 10.1016/j.ejpn.2014.12.007 [DOI] [PubMed] [Google Scholar]