Articles / Melatonin and children: when does it have a role?

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“The mainstay of managing any sleep problem is working out what the problem is and making sure there’s not an underlying medical cause,” says Dr Lexi Frydenberg, a general and developmental paediatrician at the Victorian Children’s Clinic.
“We can’t just treat the problem. We have to find out what’s happening upstream.”
A detailed 24-hour sleep history is essential to understand the nature of the sleep problem and identify whether the main difficulty is falling asleep, staying asleep or waking too early.
Dr Frydenberg recommends asking about:
A short video of the child sleeping, taken by their parents with permission, can sometimes provide useful clinical information.
It’s especially important to consider sleep-disordered breathing, Dr Frydenberg says.
“Children may breathe through their mouth, snore, gasp or have pauses in their breathing. They can be very restless, sweat, or sleep with their neck hyperextended.”
“Some children are tired and difficult to wake in the morning. Others present with hyperactivity, emotional dysregulation, difficulties with attention and concentration, or behavioural or learning problems.”
These symptoms can overlap with those of behavioural problems and ADHD, making a careful sleep history particularly important, she says.
“Sometimes an underlying sleep disorder is contributing to what we are seeing during the day.”
Structural issues like enlarged tonsils and adenoids are common contributors to obstructive sleep-disordered breathing. However, tonsil size on examination does not reliably predict the presence or severity of obstructive sleep apnoea (OSA), Dr Frydenberg notes.
Allergic rhinitis and nasal obstruction may also contribute, particularly during high-pollen periods. In children with nasal symptoms, she recommends examining the nose for signs of inflammation or pale, swollen turbinates.
If you suspect allergic rhinitis, consider a six-week trial of an intranasal corticosteroid (used consistently, not PRN), reviewing both nasal symptoms and sleep before and after.
In older children, consider delayed sleep-wake phase—a circadian rhythm disorder where a person’s sleep schedule is shifted later than normal, making it hard for them to fall asleep and wake up at socially typical times.
Other possible contributors to consider include anxiety, restless leg syndrome, sleep-related movement disorders, parasomnias, medication effects and circadian rhythm disturbances.
Melatonin may be particularly helpful in children with neurodevelopmental conditions, where persistent sleep disturbances can have a significant impact on the child and the whole family, Dr Frydenberg says.
“We know that children who aren’t getting enough sleep can have difficulties with behaviour, learning, attention, concentration, emotional regulation and even growth,” says Dr Frydenberg. “We also know there’s a massive burden on families. When the child isn’t sleeping, often nobody in the household is sleeping properly.”
In Australia, several melatonin products are TGA-registered for use in children with specific neurodevelopmental conditions. These include Slenyto, Immela, Voquily and Melakso.
Dr Frydenberg advises checking the current product information for approved indications and age ranges.
Importantly, these medicines are intended for use when appropriate sleep hygiene measures have not been sufficient.
Compounded melatonin may sometimes be prescribed when a registered formulation is unavailable or unsuitable. Families should understand that compounded preparations are generally unapproved medicines and quality assurance and formulation may differ from registered products.
Choice of formulation depends on the child’s sleep difficulties. Immediate release melatonin is generally used when the main problem is falling asleep, while prolonged-release formulations may be particularly useful for children who wake overnight or have difficulties maintaining sleep, she says.
Families can use a sleep diary to track their child’s patterns before they start treatment, recording when the child goes to bed, how long it takes them to fall asleep, how often they wake and when they get up in the morning. Keeping the diary once treatment starts will also help to show if things are improving.
Individual responses to melatonin vary, Dr Frydenberg notes.
“It is trial and error. Unfortunately, there is no blood test or genetic test that can reliably tell us which medication is going to work and how each child is going to metabolise it and respond.”
“Start low, go slow, review and decide: Is it working? Are there any side effects? And does this child still need to be on it?”
She recommends reviewing children regularly after starting treatment, often at 2, 4 and 8 weeks, ensuring that behavioural sleep strategies are being implemented alongside medication.
“Often when we reach for medication, if it works—and it can really work—all of the other things go out the window.”
“But I really don’t want children or families relying on medication alone to manage sleep difficulties.”
Although some children have been on melatonin for years, evidence for the effects of prolonged melatonin use throughout childhood is limited, she stresses.
Treatment duration depends on the child, the sleep problem and their response.
Some children may benefit from a short course, while others, particularly those with significant neurodevelopmental conditions and persistent sleep difficulties, may require longer-term treatment.
Dr Frydenberg recommends conducting a comprehensive assessment after approximately three months to determine whether melatonin remains effective and necessary.
Melatonin is not generally associated with physiological dependence or a recognised withdrawal syndrome, and gradual tapering is not usually medically necessary, she says.
“It’s not like some medications like SSRIs where we have to wean because we’re going to have a rebound effect. If a child is on a low dose, one or two milligrams, I would often not wean. Once they get up to three to six milligrams, I would probably wean, but you can do it pretty quickly.”
“And it’s really more to hold the parent’s hand through this and not stop it abruptly.”
Dr Frydenberg advises caution when considering melatonin for children without neurodevelopmental conditions. The first step involves taking a detailed history to understand why the child isn’t sleeping—while also encouraging them to work hard on behavioural strategies.
“In selected children with persistent sleep-onset difficulties, a short course of melatonin may be reasonable after other approaches have been unsuccessful,” Dr Frydenberg says. “However, this is generally off-label prescribing in Australia.”
The International Pediatric Sleep Association 2025 consensus recommendations suggest commencing at 0.5 mg and, if necessary, gradually increasing according to age with suggested maximum doses of 1 mg in 2–3-year-olds, 2mg in 4–5-year-olds, 3mg in 6–10-year-olds, and 5mg in older school-age children and adolescents.
Melatonin is not recommended for children younger than 2 years of age.
“The aim should always be the lowest effective dose for the shortest appropriate period, with regular review.”
Many families have accessed melatonin online from countries where it is classed as a supplement rather than a medication, Dr Frydenberg notes. Being unregulated, their quality and consistency can vary significantly.
An increase in accidental ingestions and calls to Australian Poisons Information Centres prompted the TGA to investigate 18 melatonin imports—finding some major discrepancies between what was on the label versus actually in the product, she says.
“In some products there was no melatonin at all. In one product, there was more than 400% of the stated amount of melatonin. Also, within a pack or box, the tablet-to-tablet variability was huge. You could have one gummy that had two milligrams of melatonin, another gummy that had five milligrams.”
“The other alarming thing was undeclared ingredients. I read one report that some of the tablets had serotonin in them.”
“So many families think they’re safe, but they actually don’t know what their child is getting.”
In September 2025, the TGA advised consumers to “exercise extreme caution” when purchasing melatonin online from overseas. In January 2026, this was updated with advice to immediately cease using unregistered melatonin products and take them to a pharmacy for disposal. Consumers and health professionals are encouraged to report any adverse events to the TGA.
Behavioural sleep management—including good sleep hygiene—is essential in all children, whether or not they are taking melatonin, Dr Frydenberg stresses.
This includes maintaining regular bedtimes and wake times, even on weekends, and establishing a predictable wind-down routine before bed. Reading, quiet music or relaxation activities can be helpful.
Screens should ideally be avoided for at least an hour before bedtime, and devices kept out of the bedroom, which should be dark (with a nightlight if needed) and a comfortable temperature.
“We often overheat our children’s rooms,” Dr Frydenberg says.
“Don’t forget exercise and nutrition,” she adds. “And particularly in our older kids, but now some of our tweens, caffeine intake and those energy drinks.”
Symptoms suggestive of sleep-disordered breathing warrant further assessment, Dr Frydenberg says.
Consider referral when there are witnessed apnoeas, persistent snoring, significant daytime effects or ongoing sleep difficulties despite addressing potentially reversible contributors.
Children with enlarged tonsils or adenoids and suspected OSA should see a paediatric ear, nose and throat surgeon for a review and consideration of surgery.
For children with less clear presentations, or those with neurogenetic conditions that increase the risk of other sleep disorders, referral to a sleep or respiratory sleep clinic may be appropriate.
Some children may need an overnight sleep study, which is the gold standard for diagnosing OSA in children. These are currently conducted in hospital, although trials of home sleep studies for children are underway.
Some hospitals offer home oximetry, which may help identify children with significant OSA and assist with prioritising ENT referrals and treatment. However, a normal oximetry result does not exclude OSA. Children with persistent symptoms may still need specialist review or a formal sleep study.
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