In Australia, melatonin is generally a prescription-only medicine (Schedule 4), but there are limited over-the-counter (OTC) options: adults 55 and over can buy low-dose (≤2mg, prolonged-release) for short-term insomnia from a pharmacist, and some specific, low-dose products (like for jet lag) are pharmacist-only. For anyone under 55, higher doses, or longer-term use, a doctor's prescription is required, and unregulated imported products are risky.
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.
Melatonin in Australia
For most adults, melatonin is classified as a Schedule 4, prescription-only medication. This means that unless you're over 55, you'll need a doctor's prescription to access it. And even if you're over 55, you need prescription if you are looking for more than 2mg.
Melatonin was discovered in 1958. It is sold over-the-counter in Canada and the United States; in the United Kingdom, it is a prescription-only medication. In Australia and the European Union, it is indicated for difficulty sleeping in people over the age of 54.
CIRCADIN contains the active ingredient Melatonin. CIRCADIN is used to improve sleep quality and morning alertness in patients over 55 years of age with poor quality of sleep.
The Medicare Card price is $31.6, the Private price is $155.56, the Entitlement Card price is $7.7 and the Safety Net price is $0.
Top 7 effective alternatives to melatonin
If you're aged over 55 years, you can buy a slow-release form of melatonin over the counter. All other people need a prescription.
Furthermore, ramelteon was found to be about 10 times more potent than melatonin in promoting sleep.
While melatonin is not prohibited, it is often sold as a minimally regulated dietary supplement and may risk contamination with prohibited substances. Try melatonin at home or in a safe environment BEFORE using it on your first trip. NEVER take melatonin for the first time on the plane.
New TGA safety advice on imported melatonin
One product contained more than 400% of the labelled content and another containing no melatonin at all. The TGA recommends that consumers stop using unregistered melatonin products immediately and take any remaining items to their local pharmacy for safe disposal.
The most common side effects of melatonin supplements are drowsiness and headaches. Many people experience vivid dreams and nightmares while taking melatonin. At higher doses, some people have other side effects including: Feeling confused and disoriented.
In some countries, melatonin is available to buy in health food shops or online. It's sold as a complementary medicine and comes as standard capsules, tablets or a liquid that you drink. However, these supplements are not authorised for sale in the UK and it's a prescription-only medicine.
In Australia, the best melatonin depends on your needs: Circadin (prescription for under 55s, OTC for over 55s) is a slow-release, natural-mimicking option for primary insomnia, while compounded or TGA-approved products are safest, as many imported supplements have quality/dosage issues, according to Healthdirect and the TGA. For reliable quality, stick to prescription forms or reputable Australian pharmacies; avoid unregulated online imports due to potential for inaccurate dosing, advises Sleep Health Foundation and TGA.
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.
not covered by the Traveller Exemption and require written permission from the Office of Drug Control when travelling to Australia:
To make sure it's safe for you, tell your doctor or pharmacist before taking it if you: have ever had an allergic reaction to melatonin or any other medicine. have liver or kidney problems. have rheumatoid arthritis, multiple sclerosis or lupus, or any other autoimmune condition.
These are the most commonly used sleeping tablets in Australia and include temazepam (Temaze, Normison), zopiclone (Imovane) and zolpidem (Stilnox). They work by enhancing the activity of sleep pathways in the brain. They are recommended for short term use (less than 4 weeks). Suvorexant (Belsomra).
Melatonin is a hormone that regulates our sleep-wake cycle. Milk, nuts, cherries, fish, rice, goji berries, and oats contain melatonin. Avoid spicy food, chocolate, tomatoes, pizza, and citrus fruits before bed. Your daily diet and sleep hygiene are key to improving sleep.
Melatonin is now available over the counter Chemist Warehouse.
The usual starting dose is one 2mg slow release tablet taken 30 minutes to 1 hour before bedtime. Sometimes the dose may gradually be increased to 2 to 3 tablets before bedtime, depending on how well it works and whether you have any side effects. The maximum dose is 5 tablets (10mg) once daily.
While melatonin is best for resetting sleep cycles, magnesium enhances sleep depth and relaxation. Studies suggest that combining both, especially with vitamin B complex, offers significant benefits for insomnia.
Doxylamine is one of the strongest OTC sleep aids. It is an antihistamine. However, it is only suitable for short-term use. A person should contact a doctor and check that doxylamine is safe for them to use before taking it.
Patients on Suvorexant had better sleep onset and maintenance than those on placebo, and the medication was generally well-tolerated over the long term. Knowing that Suvorexant is backed by evidence and approved by the Australian Therapeutic Goods Administration (TGA) can give you confidence in this treatment.