- Melatonin prescribing for young children appears to have been on the rise globally in recent years, despite a dearth of efficacy data for kids with typical development, a systematic review suggested.
- There was evidence for improved sleep onset with melatonin use in young children with neurological conditions, such as autism spectrum disorder.
- Data on long-term outcomes for other behaviors and health impacts were lacking.
Melatonin prescribing for young children appears to have been on the rise globally in recent years, despite a dearth of efficacy data for kids with typical development, a systematic review suggested.
Incidence and prevalence of melatonin prescribing in children age 6 years and under increased over time in five of the eight observational studies that assessed it, with some reporting a 500% increase, reported Chelsea Kracht, PhD, of the University of Kansas Medical Center in Kansas City, and colleagues.
Observational studies also showed increases in extended melatonin use and melatonin-related overdoses, especially over the last decade.
There was evidence for improved sleep onset in young children with neurological conditions -- such as autism spectrum disorder -- with few adverse events, the researchers noted in JAMA Network Open. However, data on long-term outcomes for other behaviors and health measures were lacking, and efficacy data were not available for kids with typical development.
"Most melatonin usage reviews [have] focused on older children (aged 7-16 years) or limited their findings to 1 diagnosis with only short-term follow-up," Kracht and colleagues wrote. "Thus, our knowledge is limited about melatonin usage and subsequent long-term outcomes in young children."
"Our review contributes to the evidence that a clear public health problem may exist with regard to the increase of unsafe melatonin practices in young children and continued use beyond clinical recommendations," they wrote.
Indeed, a recent survey of U.S. parents found that largely over-the-counter melatonin use among children ages 1 to 13 years was common, with the prevalence of melatonin consumption in the past 30 days reported at 5.6% in preschoolers, 18.5% in school-age kids ages 5 to 9, and 19.4% in those ages 10 to 13, researchers previously reported in JAMA Pediatrics.
Meanwhile, the American Academy of Sleep Medicine has issued a health advisory encouraging parents to seek medical advice before giving melatonin or any supplement to kids.
Kracht noted need for better "pediatrician and parent support of behavioral sleep practices, such as reducing night time screen-time," as well as assessing child and parent supplement usage. Additionally, "long-term medical follow-up is required for young children with neurological conditions that continue to use melatonin," she told MedPage Today.
Kracht's analysis covered studies of prescription melatonin use among children ages 0-6 years, encompassing 12 observational studies, six experimental trials, and one protocol. The observational studies reported on a mean of 9 years of data from Nordic and Australian registries as well as poisoning data from the U.S. and Portugal. Trials included 167 young children with neurologic conditions and lasted a mean of 12.7 weeks.
In four observational studies reporting on extended use of melatonin in young kids, approximately 40-50% of young children -- but as few as 10% -- had prescriptions for melatonin being refilled 2 and 3 years after their initial prescription.
Furthermore, three observational studies showed doubling or decoupling of melatonin-related poisonings or emergency department visits due to unsupervised ingestions, especially between 2018 and 2022.
Among sleep outcomes, three trials in 52 children with neurodevelopmental disorders showed significant improvement in how long it took to fall asleep with melatonin over the longer term, and total sleep time increased by approximately 1 hour in two trials. But for night awakening, three trials in 63 children with neurologic conditions had mixed results.
Regarding long-term growth and development, a 4-week study found no association with precocious puberty after melatonin treatment, and a 1-year study showed no differences between melatonin and control groups for body mass index (BMI) and BMI z scores, albeit without young child-specific results.
Methodological quality was good for six studies, fair for nine, and poor for three.
Limitations included that observational study results might not be generalizable due to varying country-level systems, and that trial results might not translate to kids with typical development, Kracht and colleagues noted. They added that some studies were unable to specifically assess young kids due to small sample sizes and that results were for exogenous melatonin and may not translate to clinical use in inpatient settings.
Disclosures
The study was supported by grants from the NIH.
The authors did not report any relevant disclosures.
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