If you have been buying melatonin online, your sleep solution could be far more dangerous than you realise.
Recent testing has revealed shocking inconsistencies in the amount of melatonin in imported products.
Families across Australia are being urged to take immediate precautions.
TGA Issues Safety Advisory
The Therapeutic Goods Administration (TGA) issued a safety advisory on 26 September 2025, following tests that uncovered extreme discrepancies between labelled and actual melatonin content.
One product contained more than four times its stated dose, while another had no melatonin at all.
Such variability placed consumers, particularly children, at serious risk of overdose and hospitalisation.
'This variability in melatonin content raises serious safety concerns for consumers, including the risk of hospitalisation and accidental overdose.'
Extreme Variations in Imported Products
The TGA tested eleven imported melatonin products and found some containing up to 417 per cent of the labelled amount, while others had barely any active ingredient.
The situation was likened to playing Russian roulette with your family’s sleep medication.
Sleepose-3 Melatonin 3mg was the worst offender, with lab results showing between 209 and 417 per cent of its labelled content.
A consumer believing they were taking 3mg could actually be ingesting more than 12mg, significantly increasing the risk of side effects.
Legitimate melatonin access for Australian seniors
Ages 55+: Available from pharmacist (2mg modified release for insomnia)
All ages: Available from pharmacist for jet lag (5mg immediate release, maximum 10 tablets)
All other uses: Prescription required from GP—Look for AUST R or AUST L number on packaging to confirm legitimacy
TGA Laboratory Findings
The testing results that shocked regulators
- Sleepose-3 Melatonin 3mg: 209-417 per cent of labelled content
- Nutraceutical Sleepose-3 Melatonin 3mg: 95-174 per cent variation
- Smurfs Kids Gummies Melatonin 1mg: 155-170 per cent variation
- Three products contained significantly less melatonin than advertised, and one contained none
These unregistered therapeutic goods often failed to meet Australian safety, quality, or effectiveness standards.
The TGA urged consumers to stop using unregistered melatonin products immediately and to return any remaining stock to a pharmacy for safe disposal.
Throwing them in the bin could put others at risk and harm the environment.
Immediate steps to protect your family
- Stop using any unregistered melatonin products now
- Take remaining products to your pharmacy for safe disposal
- Check packaging for AUST R or AUST L numbers before purchasing any sleep aids
- Consult your GP or pharmacist about legitimate alternatives
Regulatory Crackdown and Safer Sleep Options
Regulatory enforcement was intensifying, with the TGA continuing to monitor harmful unregistered products and notifying the Australian Border Force to seize and destroy intercepted shipments.
Major international retailers had already paused shipments to Australia in response.
For safer sleep, Australians could explore both medical and natural approaches.
Seniors should speak with their GP about prescription sleep aids or consult pharmacists for regulated melatonin options.
Establishing a consistent bedtime routine, keeping bedrooms cool and dark, limiting screen time before bed, and gentle daytime exercise could also improve sleep quality.
Consumers were reminded that melatonin taken without professional guidance could lead to serious side effects, including hospitalisation.
Checking for an AUST R or AUST L number on packaging confirmed compliance with Australian safety standards.
What This Means For You
Recent TGA testing revealed that imported melatonin products can be extremely inconsistent, with some containing nothing at all and others delivering more than 400 per cent of the labelled dose.
For those aged 55 and over, there is a safer option—2mg modified-release melatonin is legally available from pharmacists without a prescription, offering peace of mind and regulated dosing.
Consumers were strongly advised to stop using unregistered melatonin, return any remaining products to a pharmacy for safe disposal, and always check for the AUST R or AUST L number on packaging to ensure legitimacy.
Beyond supplements, maintaining healthy sleep habits—such as following a consistent bedtime routine, limiting screen time before bed, and consulting a GP or pharmacist about safe options—can significantly improve sleep quality and protect overall health.
Taking these precautions ensures sleep support is both effective and safe.
If you’re concerned about the safety and effectiveness of your sleep aids, it can help to also look at habits that improve sleep naturally.
Understanding the right bedtime routines and what to avoid can complement safer melatonin use and boost overall sleep quality.
For practical tips and expert advice on improving your nightly rest, this next story is a helpful guide.
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — TGA issued a safety advisory on 26 September 2025 after testing revealed significant discrepancies in melatonin content compared to labelled amounts.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — One product tested contained more than 400 per cent of the labelled content while another contained none, highlighting serious risks for consumers.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Regulation of melatonin products in Australia | Therapeutic Goods Administration (TGA) — Adults aged 55 and over can purchase legitimate melatonin from pharmacists without a prescription.
https://www.tga.gov.au/news/news/regulation-melatonin-products-australia
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — Many imported products are unregistered therapeutic goods that may not meet Australian safety, quality, or effectiveness standards.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — Consumers are advised to stop using unregistered melatonin immediately and return remaining products to a pharmacy for safe disposal.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — TGA monitors harmful unregistered products and works with the Australian Border Force to seize and destroy intercepted shipments.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Regulation of melatonin products in Australia | Therapeutic Goods Administration (TGA) — Melatonin taken without medical oversight can cause serious side effects including hospitalisation and accidental overdose.
https://www.tga.gov.au/news/news/regulation-melatonin-products-australia
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — Consumers should check for an AUST R or AUST L number on packaging to confirm a product is registered and meets Australian standards.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — Reporting suspected side effects helps the TGA identify unknown risks and emerging safety concerns.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Safety concerns over imported melatonin products | Therapeutic Goods Administration (TGA) — Consumers are encouraged to report adverse events to help monitor and respond to emerging safety concerns.
https://www.tga.gov.au/safety/safety-alerts/safety-concerns-over-imported-melatonin-products
Have you found any unregulated melatonin products in your medicine cabinet? Share your experience in the comments below—your story could help keep other families safe.
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