Prescribers should consider behavioural strategies to address sleep issues in kids before turning to melatonin, given the lack of evidence to support its use in those with ‘typical development’, a review has found. 
 
Published in JAMA Network, the systematic review of 19 studies investigating  melatonin use in young children also found a lack of evidence for long-term melatonin treatment.
 
Melatonin prescribing was found to have increased over time in five of the studies examined, with some reporting a 500% rise.  
 
Extended use and overdoses in young children aged up to six years have also increased in the past two decades.
 
While five international trials found young children with autism spectrum disorder (ASD) or related conditions fall asleep faster after treatment, ‘none examined efficacy in children with typical development or measured outcomes beyond two years’. 
 
‘These findings suggest a global rise in prescriptions without efficacy data on use in children with typical development, underscoring the need to identify strategies to prevent and reduce melatonin use in young children,’ the study said. 
 
Given the lack of data to support current trends, the researchers suggest medical professionals ‘discuss behavioural interventions with young children to reduce medication usage and overdose’. 
 
They also recommend the prescribing of melatonin for young children with ASD ‘after behavioural intervention and medical supervision’ and with follow-up.  
 
‘Even in children with ASD, long-term medical follow-up is required given the sustained use beyond three years,’ the authors say. 
 
To address the challenge of rising prescriptions, the study recommends parent education and practitioner support for behavioural sleep strategies, such as reducing night screen time and having structured bedtime routines.  
 
RACGP Specific Interests Child and Young Person’s Health Chair Dr Tim Jones said the study highlights that melatonin prescribing has dramatically increased without strong evidence for efficacy in neurotypical children.  
 
He said the key takeaway from the new study is there is a difference between its short-term use as part of a broad set of supports with sleep, and its ‘uncertain’ longer-term use.
 
‘As GPs, I recommend we take the time to deploy robust behavioural interventions and supports for families before considering melatonin,’ Dr Jones told newsGP.
 
‘We can use online resources such as Sleep with Kip or partnerships with community organisations such as Karitane that have longstanding training and experience in supporting healthy childhood sleep.  
 
‘If we do choose to prescribe melatonin it should be for short term use (less than six weeks) in conjunction with other strategies and follow families up closely to wean this medication and deliver ongoing support.  
 
‘We have no evidence of efficacy or proven safety after 12 weeks of use and need to keep this in mind.’ 
 
In the United States, melatonin is the leading substance in cases of unsupervised medication ingestion and overdose among young children under five attending emergency departments, the authors say.   
 
The frequency of these ingestions and overdoses increased fivefold from 2009 to 2021.
 
The review follows warnings from Australia’s medicines watchdog last year after it tested 18 imported melatonin products that were intercepted at the Australian border.  

It found 12 had an average melatonin content significantly different to the label’s claim, with one product containing more than 400% of the labelled content. 
 
A recent ABC investigation also revealed 1478 calls were made to the poisons hotline in 2024 relating to melatonin exposure for children aged 14 and younger. 
 
Dr Jones said the Therapeutic Goods Administration is ‘helpfully drawing attention’ to the variable quality of melatonin products and a marked increase in their use by families through online ordering. 
 
‘As GPs we have such a key role in negating any stigma for families and meeting them with respect and practical support for what is a common challenge for all parents,’ he said.  
 
‘Sleep challenges in children have been part of parenting journeys throughout history and as GPs we can normalise this and help families find what will work for them without overt medicalisation.’ 
 
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