Jetlag drug remains prescription-only in Australia
The TGA has decided to keep melatonin as a Schedule 4 medication amid fears it could be misused as a long-term treatment for sleep disorders and discipline problems.
The jetlag treatment melatonin will remain prescription-only in Australia amid fears parents could misuse the drug for children with behavioural issues.
The Therapeutic Goods Authority (TGA) rejected an application to exempt melatonin from Schedule 4 of the Poisons Standard after considering evidence that it could be misused as a long-term treatment for sleep disorders and discipline problems.
Melatonin, which is available over the counter in the United States, Canada and Europe, is a naturally occurring hormone, produced by the brain's pineal gland.
It helps coordinate the body's sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep, with blood levels increasing after the onset of darkness and peaking in the middle of the night.
It is a popular choice for international travellers as it can be used to “re-set the body clock” after travelling through different time zones.
The applicant argued that melatonin is freely sold as a food supplement overseas, and that it can be imported online from international retailers, raising concerns that there is a risk to consumers when buying such products from unverified sources, some of which are in high dosage strengths of up to 10 mg.
But the TGA’s Advisory Committee on Medicines Scheduling ruled that there was a possibility of indiscriminate use or misuse by consumers, the potential for underlying sleep conditions not being diagnosed or managed properly, and potential for interaction with other drugs.
“There is also potential that unscheduled melatonin could be used in children, which also poses a potential for misuse, eg for long-term treatment or in children with behavioural/discipline issues,” the Committee said.
Complementary Medicines Australia (CMA) said it was disappointed by the ruling.
“Melatonin, at appropriate doses, has been found to be safely and effectively used to alleviate the symptoms of jetlag, helps to reduce the time it takes to fall asleep, and helps reset the body’s sleep-wake cycle,” CMA chief executive officer Carl Gibson said.
“Melatonin has been available for more than 20 years in the US dietary supplement market, where it is used by approximately 5 percent of the population.”
Mr Gibson said a large and growing number of Australians were purchasing melatonin via online channels under the personal importation scheme.
“Products purchased online from overseas are not subject to the same regulations as those enforced in Australia, which means there may be no surety that the product contains what it says it does,” he said.
“Because, for now, melatonin remains prescription-only in Australia, we recommend that people seek the advice of a qualified healthcare professional [before purchasing online].”
Published: 10 Feb 2017