Melatonin Safety Alert: Unregulated Products Pose Risks (2025)

Did you know some melatonin supplements could be up to four times more potent than advertised? A recent study by Australia’s national drug regulator has uncovered alarming discrepancies in unregistered online products, raising serious safety concerns for families. Testing revealed that nearly a dozen brands contained either far more or no melatonin at all than what was listed on their labels—some even exceeded the labeled amount by over 400%. This inconsistency poses a significant risk, especially for children, who may accidentally ingest harmful doses.

But here's where it gets controversial: while melatonin is often marketed as a natural sleep aid, its potency varies wildly between products. The Therapeutic Goods Administration (TGA) has issued a stark warning, urging consumers to stop using these unregistered imports immediately. 'This variability in melatonin content raises serious safety concerns,' the agency emphasized, noting that improper dosing could lead to hospitalization or even accidental overdose.

The TGA is also cracking down on the importation of these products, with plans to seize and destroy any intercepted items at borders. This follows a dramatic rise in calls to Australian poisons hotlines last year, with over 1,500 reports of children ingesting melatonin—a sharp increase from previous years. Online retailers like iHerb have also paused sales to Australia after similar spikes in child-related complaints.

Melatonin, a hormone that regulates sleep cycles, is increasingly used by parents to help children sleep. However, in Australia, a prescription is technically required for medical use, typically reserved for cases like autism. Many parents bypass this by purchasing from overseas sites, where prices are lower and no prescription is needed. But the TGA warns these products may contain fake ingredients, undisclosed additives, or fail to meet Australia’s strict safety standards.

Take, for example, Sleepose-3 Melatonin 3mg, which was found to have 417% more melatonin than labeled. Similarly, Natrol Melatonin 5mg gummies had 170% more, while Live Natures Melatonin 10mg contained none at all. The TGA urges consumers to return unused supplies to pharmacies for safe disposal, stressing that 'parents are strongly encouraged to consult their child’s doctor before use, especially if the child has seizure disorders.'

Royal Australian College of General Practitioners vice president Ramya Raman highlighted the dangers: 'The medication should match the label to be safe. The main concern is safety—and the effects on children… the risk would be overdosing or poisoning.' She also warned of potential interactions between online-purchased medications and other drugs, which could compound risks.

Some parents have cited cost and convenience as reasons for buying melatonin online, but Dr. Raman urged caution: 'Many people do buy melatonin online, but there needs to be caution around this. I would highly encourage patients to talk to their GP.' The TGA has called these products 'extremely risky,' advising that children with medical conditions should never be given internet-purchased medications. ABC News has already contacted manufacturers identified in the TGA’s report to seek clarification.

Melatonin Safety Alert: Unregulated Products Pose Risks
 (2025)
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