Alarming amounts of melatonin uncovered in sleep aids
Testing has revealed some sleep aids being imported into Australia contain much more melatonin than the label says. These are the products authorities are warning Aussies about.
Aussie parents are buying melatonin products that are up to four times stronger than advertised and put kids at risk of overdose, authorities warn.
The drug regulator has issued an alert after testing popular unregulated melatonin products, and requested Border Force seize and destroy incoming products.
Melatonin typically requires a prescription in Australia, but in recent years, many – including parents – have bypassed this by buying unregistered melatonin “supplements”, typically online.
But new testing by the Therapeutic Goods Administration (TGA) has revealed eight of these popular products, including those marketed for children, contain “significantly more” melatonin than the labelled amount.
“This variability in melatonin content raises serious safety concerns for consumers, including the risk of hospitalisation and accidental overdose, especially in children,” the TGA said.
Three products had less melatonin than advertised, including one with none at all, and the “significant discrepancies” between the labelled and actual amount varied even within the one product.
The worst offender, Sleepose-3 Melatonin 3mg, contained 209 to 417 per cent of its labelled content, followed by Nutraceutical Sleepose-3 Melatonin 3 mg (95 to 174 per cent variation) and the Smurfs Kids Gummies Melatonin 1mg (155 to 170 per cent variation).
The TGA said parents were “strongly encouraged” to speak to their child’s doctor “regarding the use of melatonin, especially for children with seizure disorders as it may increase seizure frequency”.
“Melatonin products taken without appropriate medical oversight can cause serious side effects including hospitalisation and accidental overdose, especially in children,” it said.
The TGA said anyone using unregistered melatonin products should stop taking them “immediately”.
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The crackdown comes after concern over increasing non-fatal melatonin overdoses in children and a controversial decision by a popular international online retailer, iHerb, to pause Australian shipments.
Many experts welcomed the change but it sparked anxiety in many parenting support groups, particularly for parents of neurodivergent children.
Royal Australian College of General Practitioners vice president Dr Ramya Raman said she “certainly” came across children who took such products in her role as a GP.
“Parents do talk to me about melatonin that’s available over the counter,” she said.
But she said there are many options that should be considered before “jumping to medication as the first line”, and melatonin should not be taken without a doctor’s involvement.
“If sleep is a concern for the child it’s actually really important they come in to see the GP because there’s multiple reasons why kids can have insomnia,” she said.
“It could be related to another medical condition.
“It could be something in the family, something at school.
“It’s actually trying to address what the cause of it and we tend to always recommend non-medication related options to start with.”
She said “it’s really hard to know what and how much” is in unregulated, online products and the TGA test showing one product had up to four times as much melatonin as it claimed was “quite concerning”.
“The medication should match the label to be safe,” she said.
“When we don’t necessarily know how much is in there, and how long patients have been taking this for, there’s always the risk of overdosing.”
She said children on too much melatonin may be drowsy during the day - which was “counterproductive to what it’s actually being used for” - or become unwell.
“Overdosing can have significant impacts like nausea, vomiting, diarrhoea,” she said.
None of the products tested by the TGA had been listed on the Australian Register of Therapeutic Goods, which offers a searchable database of approved goods.
Unregistered products can be purchased both online and at in-person stores, but the TGA warns they “may not meet Australian standards for safety, quality and effectiveness”.
In Australia, melatonin is approved for kids with autism or Smith-Magenis syndrome.
It may be prescribed “off-label” to other kids, including those with ADHD.
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Originally published as Alarming amounts of melatonin uncovered in sleep aids
