Other safety alerts
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| Australia: Regulation of melatonin products in Australia |
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The Therapeutic Good Administration (TGA) announces that there has been an increase in Australians purchasing melatonin products from online stores, particularly for use in children. These products are often sold as gummies but are also available as tablets or capsules marketed as dietary supplements.
Consumers who import these unregistered ‘melatonin’ products from online stores for personal use or use by an immediate family member risk serious health problems.
In Australia, melatonin is only approved for use in children as a prescription-only medicine in limited circumstances.
Specifically, melatonin is approved for the treatment of insomnia in children and adolescents (2-18 years) with Autism Spectrum Disorder (ASD) and/or Smith-Magenis syndrome.
The TGA has not evaluated the safety or efficacy for broader use in children.
The TGA advises that children suffering from any medical condition, including sleep disorders or irregular sleep patterns, should see a doctor and not be given medicines purchased over the internet.
Consumers should exercise extreme caution when considering purchasing medicines from overseas websites. These products are not included in the ARTG. Importantly, this means they may not meet Australian standards for safety, quality and effectiveness. These products may contain incorrect or undisclosed and harmful ingredients.
Recent testing by TGA Laboratories has shown many of these melatonin products contain significantly higher doses than the amount on their label, while others contained less or even no melatonin.
Unregistered products, especially those sold by online sellers that do not request a doctor's prescription, are extremely risky. Consumers can be put at serious risk of unpredictable or severe adverse reactions.
Parents are strongly encouraged to consult their child’s treating medical practitioner regarding the use of melatonin. Melatonin products taken without appropriate medical oversight can cause serious side effects including hospitalisation and accidental overdose, especially in children.
Please refer to the following website in TGA for details: http://www.tga.gov.au/news/news/regulation-melatonin-products-australia
In Hong Kong, there are no registered pharmaceutical products containing melatonin. The DH will remain vigilant and continue to monitor the safety of the products concerned.
Ends/ Saturday, September 27, 2025
Issued at HKT 12:00
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