Prescription requirements eased on over-the-counter melatonin tablets

Australia’s Therapeutic Goods Administration (TGA) is easing restrictions on some melatonin products from June, making these available over the counter at pharmacies, rather than by prescription.

While melatonin supplements are most often used as a treatment for insomnia, such tablets have long been popular with regular travellers as well in helping manage and minimise the impacts of jet lag.

The body naturally produces melatonin at night, or in the absence of daylight. Some use melatonin supplements to nudge this process along and help get to sleep: particularly after crossing time zones to help the body adapt.

For many years melatonin supplements have only been available by prescription in Australia, being classified by the TGA as a ‘Schedule 4’ medicine.

But as of June 1 2021, “melatonin in modified release tablets containing 2mg or less of melatonin … in packs containing not more than 30 tablets” moved to Schedule 3: ‘Pharmacist Only Medicine’.

Under-55s will still need a prescription

The redesignation comes with a notable catch: pharmacists will only be able to supply melatonin without a prescription to “adults aged 55 or over”.

Anybody younger than 55 would still require a script from their doctor – as would those requesting a dose stronger than 2mg, as well as for any melatonin supplement other than in a “modified-release tablet”.

Modified-release pills are designed to delay the delivery of a drug inside the body after being taken.

The human body normally secretes melatonin at night to help maintain sleep, although this declines with increasing age, reflected by the 55+ restriction on supply in pharmacies.

“(We) have not identified any compelling evidence which establishes that melatonin can be safely supplied to consumers, by a pharmacist, outside the current approved indications, which include a restriction to individuals aged 55 years and over,” the TGA advises.

Melatonin more commonly available overseas

While Australia has kept melatonin supplements under lock and key, many other countries make melatonin readily available in pharmacies.

In the United States, for example, melatonin is available on chemist shelves, including stronger doses such as 5mg.

Some find a 5mg dose more effective against jet lag than the 2mg modified-release pills, as will become available in Australian pharmacies prescription-free.

New Zealand has also recently reclassified melatonin as a pharmacy-only medicine, covering standard doses of up to 3mg and modified-release tablets up to 2mg when sold to adults aged 55 years and over.

Some Australian travellers choose to purchase these items overseas and bring them home to Australia under what’s known as the “traveller’s exemption”, although strict conditions apply.

Melatonin and the “traveller’s exemption”

The Australian Government’s Office of Drug Control (ODC) advises that “Australian residents returning from holidays can bring in most medicines and medical devices in their accompanied baggage under the traveller’s exemption.”

That exemption allows travellers to carry medicine for their own personal use, including medicines obtained overseas such as melatonin, although restrictions apply.

“Australian residents require a valid prescription from an Australian doctor for the medication they are travelling with,” says the ODC, or “a letter from your doctor that states you are under their treatment and that the medication(s) you are carrying have been prescribed for your personal use.”

Medicines brought into Australia should also be kept in their original packaging, with a dispensing label.

At most, a traveller can carry a three months’ supply under the exemption, and they must also “declare all medication to Australian Border Force upon arrival”: a requirement that the ODC lists in bold.

The Australian Medical Association (AMA) adds that “Australians are purchasing stronger melatonin products from overseas suppliers and this can create a safety risk if the country of origin does not have the same or better standards or regulation as Australia.”

Australia’s federal Department of Health underscores that “it is against the law to bring medicines and medical devices into Australia to give to someone else,” including supplements such as melatonin purchased in overseas pharmacies.

Also read: How to tailor your jet lag strategy to suit each trip

This article is not published as medical or legal advice, and is drawn from publicly-available information available at the time of writing.

Any medical questions should be asked of your doctor or pharmacist, and any questions about Australian Border Force and other Australian Government rules and regulations – including policies regarding travelling with medicine – should be asked of the relevant government department, and independently confirmed prior to travel.

Chris C.

Chris is a a former contributor to Executive Traveller.