Melatonin and childhood sleep problems: what parents should know
As families return to school-term routines, sleep difficulties often resurface. For many parents, particularly those raising children with neurodevelopmental conditions, melatonin has become a widely discussed option. Yet its growing use raises important questions about regulation, effectiveness and safety.
Melatonin is a hormone naturally produced by the pineal gland in the brain. It plays a key role in regulating the sleep–wake cycle, the body’s internal clock that helps us feel alert during the day and sleepy at night. Melatonin levels usually rise in response to darkness, signalling that it is time to sleep. The medication sold as melatonin is a synthetic version of this naturally occurring hormone.
In adults, melatonin is commonly used to manage jet lag or sleep disruption linked to shift work fatigue. In recent years, however, its use in children has increased. In England, overall melatonin use has risen sharply, from around two prescriptions per 1,000 people in 2008 to nearly 20 per 1,000 by 2019, representing a tenfold increase.
In the UK, melatonin is available only on prescription. It is licensed for the short-term treatment of insomnia in adults aged 55 and over. There are also limited melatonin preparations licensed for use in children with neurodevelopmental conditions or genetic brain conditions that disrupt normal sleep patterns.
Children with neurodevelopmental disorders commonly experience sleep difficulties. These may include problems falling asleep, irregular sleep–wake patterns, frequent night waking and shorter overall sleep duration.
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In contrast, in the US melatonin is regulated as a dietary supplement rather than a medicine. It can be purchased in supermarkets and online without medical oversight. This looser regulation has raised concerns. Studies have found that the actual melatonin content in US supplements often differs substantially from what is stated on the label: in one analysis the measured amounts ranged from about 83% less than advertised to up to 478% more.
The scientific evidence for melatonin’s effectiveness in children is mixed, though there is some support for its use in specific groups. A trial involving children with autism spectrum disorder (ASD) found that those taking melatonin slept, on average, about 32 minutes longer than those given a placebo, after accounting for other factors that influence sleep. Melatonin also helped children fall asleep around 25 minutes faster.
Similar benefits have been reported in children with attention-deficit hyperactivity disorder (ADHD), where melatonin helped address disruptions to circadian rhythms, the body’s internal timing system, and improved overall sleep. A 2023 review examined children and adolescents with idiopathic chronic insomnia, meaning long-lasting insomnia with no identifiable medical cause.
It found moderate improvements in sleep, alongside an increase in side effects, though no serious adverse effects were reported. The authors recommended that melatonin should be used only when sleep problems persist despite non-pharmacological approaches, regardless of whether a child has ASD or ADHD.
Evidence on long-term benefit remains limited. Most clinical trials last only a few weeks or months. A 2024 UK clinical audit analysed data from more than 4,000 children and adolescents prescribed melatonin. It found wide variation in prescribing practices. While melatonin was usually started appropriately, follow-up was often poor. In many cases, prescriptions were continued without checking whether the medication was still effective or necessary.
Melatonin is often perceived as “natural”, but this does not mean it is risk-free. Its safety profile has been examined in a review of more than 30 clinical trials across different age groups. Daily doses ranged from very small amounts, such as 0.15mg, to higher doses of up to 12mg. Although a few studies followed participants for as long as 29 weeks, most were short-term, typically lasting no more than a month.
Across these trials, side effects were generally uncommon and mild. The most frequently reported included daytime sleepiness, headaches, dizziness, minor sleep disturbances and occasional drops in body temperature.
More serious effects, such as agitation, fatigue, mood changes, nightmares, skin irritation or heart palpitations, were rare. When side effects did occur, they usually resolved within a few days or stopped once melatonin was discontinued. Overall, melatonin appears to be well tolerated for most users, but the quality of evidence is low and robust long-term safety data is lacking.
A separate review focusing on children and adolescents similarly found that side effects were usually mild and non-serious. However, the authors noted mixed evidence suggesting that long-term use might affect pubertal development, highlighting an area where further research is needed.
More recently, a study reported a possible association between long-term melatonin use and heart failure in adults. However, the findings were not conclusive. Taken together, the lack of clear long-term safety evidence across all age groups reinforces the need for cautious prescribing and further high-quality research.
Regulation plays a major role in how closely melatonin use is monitored. In the UK, where it is only available on prescription, clinicians are expected to review its ongoing need, yet audits suggest this does not consistently happen. In the US, where melatonin is readily available as a supplement, families may understandably turn to it earlier, sometimes before trying behavioural approaches that may be equally or more effective.
Behavioural and environmental strategies remain the first-line approach for childhood sleep difficulties. These include maintaining consistent bedtime routines, limiting screen use in the hour before bed and optimising light exposure by keeping evenings dim and mornings bright. R
egular daytime exercise may help promote sleep, while avoiding sugary foods and caffeine before bedtime can reduce restlessness. Addressing anxiety and sensory sensitivities is particularly important for children with neurodivergence. Cognitive behavioural therapy for insomnia (CBT-I), adapted for children, can also be effective.
When these strategies are insufficient and sleep problems significantly affect a child’s wellbeing, melatonin may be considered under medical supervision. It should be used as part of a broader sleep plan rather than as a standalone solution.
The contrast between the UK’s prescription-only system and the US supplement market highlights how uneven the safeguards are. Ultimately, what children need most is support that prioritises strong foundations for healthy sleep.
Dipa Kamdar does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.