Parents purchasing unregulated melatonin gummies to put kids to sleep

Doctors are alarmed children as young as one have been given this sleep aid as families ditch proper medico channels to order unregulated gummies online.

Doctor Tim Jones. Picture: Nikki Davis-Jones

One in seven Australian kids have been given melatonin but less than a third of parents sourced it from a doctor,amid revelations babies have been given the sleep aid by parents who are often bypassing prescriptions and ordering high-strength gummies online.

The extent of the crisis has been laid bare after major online retailer iHerb suddenly suspended sales of melatonin to Australia this week amid surging overdoses from gummies, which can be purchased online.

Melatonin products shouldn’t be given to children under two but Royal Australian College of General Practitioners chair of child and young person’s health Tim Jones revealed there has been a concerning age creep.

“Initially I was seeing school age kids — it’s now not uncommon for me to see kids even under two (who’ve been given melatonin),” he said.

He has even met some children who had been given it as babies.

Dr Jones said whereas parents used to come to him first for sleep strategies, they were now approaching him having already given their kids melatonin.

Melatonin is a hormone that helps regulate sleep and can be taken in medication form, but side effects may include headaches and nausea.

Parents have had mixed experiences with it — some kids had vivid dreams that caused distress, Dr Jones said.

This week US retailer iHerb suspended melatonin sales to Australia after reports of kids in Western Australia overdosing on gummies.

“I know lots of families who due to cost reasons have ordered online,” Dr Jones said.

The NSW Poisons Information Centrehas recorded a surge in calls regarding melatonin exposure in kids.

Calls concerning accidental ingestion in children 14 and under rose from 297 in 2022 to 400 in 2024.

Therapeutic error reports — which could include an incorrect dose — in this age group increased from 189 to 227.

Dr Jones said there was “deep concern” over parents purchasing poorly regulated products online, where melatonin content could vary wildly to what was advertised.

In Australia, melatonin is approved for kids with autism or Smith-Magenis syndrome.

A Therapeutic Goods Administration spokesman said melatonin was not approved for other children, noting the TGA had not evaluated safety for broader use in the cohort.

It may be prescribed “off-label” to other kids.

Melatonin is also available without a prescription to people over 55 or adults treating jet lag, but otherwise requires one, the TGA said.

Melatonin gummies sold online resemble lollies. Picture: istock

Research by the Royal Children’s Hospital, which surveyed parents with kids aged five to 17 across Australia, found 14 per cent of kids had been given melatonin.

Sleep pediatric consultant Dr Moya Vandeleur said just under a third was obtained via a doctor’s prescription.

One third was sourced online and about another third over the counter.

“Online melatonin products are often from countries where melatonin’s not regulated (as a medication) and may have higher doses than what appears on the label,” she said.

“This can increase the risk of side effects.”

Families may miss out on doctors identifying underlying causes for insomnia, like a mental health issue, if they turned to melatonin instead of seeking professional help, she said.

“We always advise that you should try behavioural sleep interventions first and if you’re going to go down the line of using melatonin it should be prescribed and monitored by a doctor,” she said.

Dr Jones said there was limited data around long-term melatonin use in kids.

“We need stronger regulation to ensure that the safety and quality is there,” he said.

The TGA spokesman said it was aware of alleged unlawful advertising, supply and importation of therapeutic goods from online platforms based overseas, including melatonin.

“Overseas, some products considered prescription medicines in Australia, like melatonin are regulated as supplements – meaning there is less controls and oversight,” he said.