Consumers are circumventing Australian regulations to buy cheap melatonin from overseas where it can be obtained without a prescription.

The high price and hassle of getting the sleep drug in Australia are driving many consumers to buy it from international websites that sell directly to Australian consumers without the oversight of the Therapeutic Goods Association, or from pharmacies on trips abroad to countries such as the United States where it’s sold over the counter.

Melatonin is a synthetic version of the natural hormone that regulates sleepiness and in Australia it’s only sold with a prescription. Fairfax Media revealed last week there was a growing trend to use it for children.

Many families Fairfax Media spoke to had melatonin prescribed for a child but turned to overseas suppliers because they couldn't afford the high price of buying it from a compounding pharmacy.

Health experts warn there could be safety concerns with buying melatonin from overseas. Previous tests found significant quality and purity issues in 31 melatonin products sold over the counter in Canada.

“It is a synthetic drug and I have such a worry about people buying it online – it’s [almost] like going to a rock concert and buying a pill, you don’t know what it is,” said Professor Sarah Blunden, a clinical psychologist and the head of paediatric sleep research at Central Queensland University.

“I honestly don’t understand why people do that, except I know people must be so desperate. We need to have a stronger understanding that even in a society where these drugs are freely available, it’s still a drug.”

Paediatricians are also alarmed parents could source melatonin directly for their children without medical advice. A doctor might diagnose other, possibly serious, reasons for the sleep problem.

Professor Harriet Hiscock, a paediatrician at Royal Children’s Hospital Melbourne, said melatonin should remain a prescription drug because behavioural strategies work for most children. While there is good evidence that melatonin is safe and effective, there have been no long-term studies conducted involving children.

“If it became freely available families would be bypassing the behavioural, non-pharmacological strategies,” Professor Hiscock said.

There are a handful of melatonin suppliers in Australia: Aspen, which makes pharmaceutical brand Circadin, a slow-release tablet designed for adults; and wholesalers that supply compounding pharmacies. Compounding pharmacies can make up a formulation with a tailored dosage, with the choice between tablets or liquid suspension.

The drug is not on the pharmaceutical benefits scheme and it costs about $30 for a packet of 30 Circadin pills and about $80 for a bottle of liquid melatonin for a child made by a compounding pharmacy.

The only melatonin products sold over the counter in Australia are homeopathic formulations.

But in many countries, melatonin is treated as a food supplement and sold over the counter. This includes the US, where it's the fourth most popular "natural product" taken by adults, and the second most popular for children, behind fish oil. The global market was expected to be worth more than $US1.3 billion by 2019, with the US accounting for more than half, according to Transparency Market Research.

But a 2017 study published in the Journal of Clinical Sleep Medicine found huge variability in the quality and purity of over-the-counter melatonin sold in one city in Canada. It's no longer sold over the counter in Canada.

The study found high variability between and within brands, with melatonin content varying from -83 per cent to +478 per cent of what was on the label. One chewable tablet – most likely to be used by children – contained almost 9mg of melatonin when it was meant to have 1.5mg. Some products were contaminated with serotonin, which could have medicinal effects of its own.

In February last year the TGA reviewed the status of melatonin in Australia but ruled out changing the scheduling. In its decision the TGA cited the risk of misuse by consumers, the potential for underlying sleep conditions not being diagnosed or managed (especially in children), the potential for interaction with other drugs, and reliance on long-term use of melatonin for children with behaviour or discipline problems. 

However, it’s legal for Australian consumers to bring melatonin into the country without a prescription or to order it from international websites.

Professor Hiscock said it was "reasonable" to buy melatonin from overseas once you had established usage under medical supervision, but she would advise sticking to reputable brands from established companies.

Mia Guille, 14, has had trouble sleeping for most of her life.Credit:Janie Barrett

Alison Guille from Beverly Hills in Sydney orders it online for her daughter Mia, 14. When the drug was first prescribed for Mia, her daughter, then nine, was only sleeping four or five hours at night.

At first Ms Guille bought it from a compounding pharmacist but she couldn’t keep up with the expense. A friend who works as a flight attendant brought back several products for Mia to try so they could figure out the right one.

Ms Guille wishes melatonin was available over the counter in Australia partly to “make life so much easier” but also because she would trust buying it from her local chemist more than a website.

“You worry about buying stuff like that online, it seems a bit dodgy,” Ms Guille said.

Charmaine, a mother of three from Canberra, buys it online for her daughter, nearly 10, under the supervision of a GP and a psychologist.

"I have a standing monthly order and I just get delivered it, it's like a vitamin there," she said.

Charmaine has been happy with the quality and points out the website, BIOVEA, was recommended to her by a health professional.

Source: Read Full Article