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TGA issues warning on online melatonin
For the first time, the TGA is urging the use of prescription-only melatonin, after its tests found one imported product contained four times the listed amount.
Of the imported melatonin products tested by the TGA, eight contained ‘significantly more’ melatonin than the labelled amount.
The Therapeutic Goods Administration (TGA) has issued its first safety alert and public statement related to imported unregistered melatonin products, after its own tests concluded that consumers ‘risk serious health problems’ from the products.
It has also advised consumers to ‘immediately’ stop using unregistered melatonin products and take any remaining products to their pharmacy for safe disposal.
In a public statement issued on Friday, the TGA urged consumers to see their GP to obtain prescription-only melatonin, particularly for children, after finding ‘significant discrepancies’ in labelled content of several online products.
‘Unregistered products, especially those sold by online sellers that do not request a doctor’s prescription, are extremely risky,’ said the TGA.
‘Parents are strongly encouraged to consult their child’s treating medical practitioner regarding the use of melatonin.’
The statement accompanies the TGA’s safety alert, which includes its laboratories’ own findings on the imported unregistered melatonin products.
Of the products tested, eight contained ‘significantly more’ than the labelled amount, while two had ‘significantly less’ and one contained no melatonin at all.
The authority said the variation its test results revealed raise ‘serious safety concerns for consumers’.
‘Consumers who import these unregistered “melatonin” products from online stores for personal use or use by an immediate family member risk serious health problems,’ it said.
‘Melatonin products taken without appropriate medical oversight can cause serious side effects including hospitalisation and accidental overdose, especially in children.’
In recent years, melatonin use has surged worldwide. The United States’ National Institutes of Health reported that, between 1999 and 2018, the use of melatonin supplements by American adults increased five-fold.
One of the most popular US brands tested by the TGA, ‘Health Melatonin 3 mg’ from national pharmacy chain CVS, showed variations of 112–121% from the labelled amount, while another, Sleepose-3 Melatonin 3 mg, showed variations of 209–417%.
In one brand, Live Natures Melatonin 10 mg, no melatonin was detected.
A TGA spokesperson told newsGP the authority continues to ‘urge consumers to exercise extreme caution when purchasing medicines from unknown websites, social media or other digital platforms’.
The TGA has previously warned consumers of the dangers of buying any health products online.
However, a recent spike in reports of melatonin overdoses, along with the TGA’s own testing, has prompted the targeted announcement.
In August, American online retailer iHerb suspended all sales of melatonin products to Australia, shortly after reports of a rise in reported overdoses.
RACGP Specific Interests Child and Young Person’s Health Chair, Dr Tim Jones, has become a prominent spokesperson on the dangers of unregulated melatonin products.
In particular, he recently told newsGP he has ‘a dubious level of trust’ for ‘lolly-like’ gummies, after a 2023 US analysis of 25 gummies found between 74–347% of the advertised content of melatonin.
Dr Jones has called for a return to sleep issues being considered ‘normal’ by parents and GPs, and for strategies to be considered before medication.
‘It’s great to see the TGA carefully looking at the safety of products being marketed for children,’ he told newsGP in response to the recent TGA statement.
‘It seems their findings dovetail perfectly with what was already suspected.’
Acknowledging that some GPs may choose to prescribe melatonin off-label, the TGA has encouraged GPs to report any adverse health events.
‘Health professionals … play a key role in identifying and managing the risks associated with unregistered melatonin products and should advise patients accordingly,’ it said.
Editor’s note, 30.09.2025: This story has been updated to correct a reference to a study that reported differences between advertised and actual melatonin content levels.
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