Melatonin Use in Australian Children: Are We Getting It Right?

Behavioural strategies are the cornerstone of managing paediatric insomnia, with pharmacological interventions rarely indicated. Despite this, use of both prescribed and over-the-counter melatonin has been on the rise. In response, The International Pediatric Sleep Association (IPSA) published expert consensus recommendations for healthcare providers for melatonin use in both typically developing children 1 and children with autism and other neurogenetic disorders 2. Both statements recommend that melatonin only be used with the recommendation and supervision of a medical provider, should be accompanied by behavioural approaches to insomnia, and the use of online non-verified melatonin products should be discouraged 1, 2. The Royal Children's Hospital National Child Health Poll (NCHP) sought to investigate children's sleeping habits and behaviours by surveying Australian parents/caregivers of school aged children (aged 5 to 17 years) from 25 November to 2 December 2024. The survey was administered to a randomly selected parent/caregiver population and data weighted by age, sex, state of residence, number of children in the household, socioeconomic and indigenous status, to reflect the demographic characteristics of the Australian population. The completion rate was 68%, with 1654 parents reporting on 2555 school aged children; 56.0% of children were identified as having a problem with their sleep according to parents/caregivers. Irrespective of reported sleep problems, parents/caregivers were asked for all children ‘Has your child ever taken melatonin for difficulties with sleep (not for jet lag)?’ 14.4% (n = 393) of children had taken melatonin, with a relatively even distribution across primary school (13.0%, n = 210) and high school (16.9%, n = 183) age groups. Table 1 depicts the source of melatonin products used. Less than one third of children using melatonin had a prescription. Among children using melatonin, 33.5% of children (38.1% primary school, 27.2% high school) were given melatonin sourced online. In Australia, melatonin for the paediatric population is a schedule 4 pharmaceutical, with prescribed compounded products often hard to access and expensive for families. While off-prescription sources of melatonin sold online are frequently more cost effective, they are often imported from countries where melatonin is unregulated and at risk of contaminants. Preparations such as gummies and chewable tablets are popular as they are appealing to children, likely increasing the risk of them being consumed in excess. In a study conducted on the quantity of melatonin in gummies sold in the United States, the variability of actual melatonin content compared to labelled, ranged from melatonin ‘not detected’, to 347% of that indicated 3. The IPSA guideline for typically developing children recommends a maximum dose of 3 mg in primary school age children (6–10 years) and 5 mg in older school age and adolescents 1. The melatonin dose in gummies exceeded the maximum dose for primary school age in 88%, and for older children in 52% of brands of gummies tested 3. Higher than recommended dosages may increase the risk of side effects, such as fatigue, vomiting, mood swings, headache and rash, without added therapeutic benefit 1, 2. One large US based company recently suspended sales of all melatonin products in Australia following a rise in reported overdoses 4, highlighting the risks and vulnerability of our current supply system for this commonly used medication. The frequency of off-prescription melatonin use in Australia in this study was comparable to a 2023 Australian survey of a population of parents of children experiencing sleep disturbances in the last two years 5. Briefly, 22.5% of parents surveyed administered melatonin without a prescription, and 35.4% administered it without monitoring by a health professional. This paper also investigated factors associated with melatonin use, with higher parental stress, older child age, and a diagnosis of ADHD being significantly associated with use 5. The IPSA consensus statements recommend that children should have a thorough clinical sleep evaluation to rule out other causes of insomnia before starting melatonin. It also recommends age-appropriate healthy sleep practices and parent-directed behavioural interventions as first line for typically developing children with chronic insomnia 1. This is in keeping with current standards of practice of paediatric sleep physicians in Australia. NCHP parent/carer data showed 71.6% of children who had taken melatonin did so without a prescription and possibly without supervision from a health professional. It is unclear if these children had clinical sleep evaluations prior to starting melatonin or if families had guidance regarding age-appropriate behavioural interventions. Without these important steps, the success of treatment of paediatric insomnia is likely to be impaired. It is concerning that parents may have commenced their child on melatonin without medical advice on appropriate dose and timing of administration. A qualitative survey of caregivers and pharmacists in Australia in 2024 regarding melatonin use in school-aged children demonstrated knowledge gaps and uncertainties about paediatric melatonin use 6. Caregivers commented on the lack of guidance on appropriate timing of administration of melatonin, and 50% of caregivers individually titrated the dose administered. Pharmacists commented on the lack of clinical guidance for paediatric melatonin, needing to defer to the prescribers' instructions 6. Pharmacists also commented on the need for greater clarity of therapeutic dosage thresholds and dosage titrations when initiating or discontinuing melatonin 6. In this first study of a nationally representative sample of Australian parents and caregivers exploring melatonin use in children, findings indicate that parents commonly perceive children as having sleep problems, and use of unregulated off-prescription melatonin is commonplace. This comes with inherent risks of inappropriate indication, missed comorbidities, incorrect dose, risk of side effects and contaminants. Behavioural interventions are the current recommended first-line management for sleep initiation difficulties and paediatric insomnia. Health professionals, including General Practitioners, must be upskilled in implementing behavioural sleep interventions, to make management strategies more accessible to families. For children and adolescents where melatonin is indicated, safe, regulated, affordable and accessible sources of melatonin need to be made widely available. The authors have nothing to report. The study was approved by the Royal Children's Hospital Human Research Ethics Committee (#35254). The authors declare no conflicts of interest. The data that support the findings of this study are available from the corresponding author upon reasonable request.