News | Regulation
In Britain It Takes a Prescription. In America It Comes in Gummies. How Melatonin Rules Split the World.
The same hormone is a pharmacy medicine in one country and a candy aisle supplement in the next. Canada tightened its rules this year, and Australia may loosen its own.
Fly from New York to London with a bottle of 10 mg melatonin gummies in your bag and you will be carrying something British pharmacies cannot sell you without a prescription.
Melatonin is the same molecule everywhere. How it is sold depends almost entirely on where you live.
United States: a supplement
Under the Dietary Supplement Health and Education Act of 1994, melatonin is a dietary supplement. It does not need FDA approval before sale, and it is sold in gummies, tablets, sprays and drinks in doses well above what the body makes.
In March 2024, the Council for Responsible Nutrition, an industry group, adopted voluntary guidelines for child deterrent closures and warning labels on flavoured melatonin. They are not required by law.
United Kingdom: prescription only
In the UK, melatonin is a prescription only medicine. The licensed product, Circadin, is a 2 mg prolonged release tablet approved for primary insomnia in adults aged 55 and over.
Europe: it depends on the country
Circadin is authorised as a prescription medicine across the EU, but melatonin's status as a food supplement differs from country to country.
- Denmark and the Czech Republic have not allowed it in supplements.
- Germany and Belgium have treated doses of 0.3 mg a day or more as a medicine.
- Italy and Spain allow supplements up to 1 mg a day. Italy cut its limit from 5 mg in 2013.
The EU's food safety agency has approved health claims at 1 mg, for falling asleep faster, and 0.5 mg, for jet lag. National rules change, so check your own country's regulator.
Australia: behind the counter
Melatonin is prescription only in Australia by default. There are two pharmacist only exceptions: prolonged release tablets of 2 mg or less for adults 55 and over with insomnia, in packs of up to 30, and immediate release products of 5 mg or less for jet lag in adults, in packs of up to 10.
In March 2026, the Therapeutic Goods Administration consulted on moving these products to pharmacy medicine status, which would loosen the rules. We could not confirm a final decision.
Canada: tightened for children
Adults in Canada can still buy licensed melatonin as a natural health product. Since June 2, 2026, melatonin for sleep related use in children and teenagers under 18 has been a prescription drug.
Why the split matters
It shapes the research, too. A large 2025 study that linked long term melatonin use to heart failure found users through prescription records. That works in the UK, where melatonin is prescription only. In the US, people buying it off the shelf were counted as non users.