Melatonin is the top cause of accidental medicine exposure in under-sevens, a review finds

Melatonin is inexpensive, easily accessible and in high demand from the community [s2], and it is widely given to small children who are not sleeping. A systematic review published in JAMA Network Open on 2 January set out to establish what is actually known about giving it to children aged 0 to 6 [s1].

The answer is that very little is known, and that the gap between how much it is used and how much it has been studied is the finding.

The safety signal that opens the paper

The review's stated premise is a surveillance fact rather than a trial result: melatonin is the leading cause of unsupervised medication exposure and overdose presenting to emergency departments among children aged 0 to 6 [s1].

That is a statement about accidental ingestion — a child finding a bottle — rather than about harm from intended doses. But it is a direct consequence of a product being treated as harmless enough to leave within reach, in a formulation that tastes like confectionery.

What the evidence base contains

The authors searched nine databases including Ovid MEDLINE, Embase and Web of Science, plus two clinical trial registries and existing systematic reviews, with forward and backward citation searching, from inception to 26 February 2025 [s1]. They looked for observational and interventional studies of the safety and effectiveness of exogenous melatonin on sleep in young children [s1].

They found 19 articles: 12 observational studies, 6 trials, and 1 protocol, published between 2000 and 2025 [s1].

The observational studies drew on nine years of data on average (range 3 to 21 years) from Nordic or Australian registries, or poisoning data from the United States and Portugal [s1]. What they document is not effectiveness but usage: rising prescribing, extended duration of use, and overdoses, especially over the past decade [s1].

The six trials included 167 young children in total, all with neurologic conditions such as autism spectrum disorder, and lasted a mean of 12.7 weeks (range 2 weeks to 2 years) [s1]. In that population, the trials provided evidence for improved sleep onset, with few adverse events [s1].

Methodological quality, assessed with the Downs and Black checklist, was poor for 3 studies, fair for 9 and good for 6 [s1].

The absence that matters

Two gaps are named explicitly. Data on long-term outcomes for other behaviours and health outcomes were absent [s1]. And efficacy data were not available for children with typical development [s1].

That second point is the one to hold on to. The entire randomised evidence base for melatonin in this age group consists of 167 children who had neurologic conditions. Children who are typically developing and simply will not go to sleep — the largest group of users by a wide margin — are not represented in any trial the review could find.

The authors' conclusion describes a global rise in prescriptions without efficacy data for typically developing children, and calls for strategies to prevent and reduce melatonin use in young children, alongside better paediatrician adherence to evidence-based practice standards [s1].

The clinical view

A review in Paediatric Respiratory Reviews, published 21 January, addresses the same problem from the consulting room [s2].

Its framing is that behavioural sleep problems are common in children, and that establishing good sleep hygiene is genuinely difficult against environmental pressures — the ready availability of electronic media from a young age, permissive parenting, difficult family dynamics, and limited parental understanding of how a child's sleep needs change through childhood and adolescence [s2].

Into that difficulty comes a product that is inexpensive, easily accessible, in high demand, and, at its simplest, perceived as a harmless silver bullet for sleep problems [s2]. The authors note that clinicians are now routinely encountering children already taking melatonin, sometimes with minimal behavioural support and with misconceptions about its safety [s2]. Their review sets out melatonin's approved indications, the dangers of unregulated products, and the risks of unsupervised use [s2].

The phrase "unregulated products" carries weight. Where melatonin is sold as a supplement, the amount in the bottle is not necessarily the amount on the label, and neither paper's evidence base was generated using the products most parents can buy.

What this article is not

This is not guidance about whether any child should take melatonin, at what dose, or for how long. Both papers are explicit that those decisions belong with a clinician who knows the child, and both are describing an evidence base too thin to support general rules.

What to watch

Whether a trial is ever run in typically developing young children — the population where use is highest and evidence is entirely absent — and whether jurisdictions that classify melatonin as a supplement revisit that classification in light of the poisoning data.

Sources

1. [s1] Melatonin Use in Young Children: A Systematic Review. JAMA Network Open, 2 January 2026. https://doi.org/10.1001/jamanetworkopen.2025.51958
2. [s2] Reframing and clarifying melatonin use in paediatric sleep care. Paediatric Respiratory Reviews, 21 January 2026. https://doi.org/10.1016/j.prrv.2026.01.003