Insomnia treatment goes OTC

Modified-release melatonin downscheduled to Pharmacist Only from 1 June

Modified-release melatonin has been downscheduled to Schedule 3 (Pharmacist Only) for the treatment of primary insomnia from 1 June 2021.

The decision is restricted to short-term monotherapy in people aged 55 or over, with tablets containing 2mg or less in packs up to 30 tablets.

Currently there are 11 registered medicines containing 2mg modified-release melatonin on the ARTG, the most recognisable of these being Circadin.

The TGA delegate said they were “satisfied that the risk profile of melatonin is well defined and the adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist”.

“Consumer consultation with a pharmacist is necessary to reinforce and/or expand on aspects of the safe use and appropriate supply in line with the approved indications,” said the delegate.

“There may be potential for harm if melatonin is used inappropriately, however, I am satisfied that it is substantially safe with pharmacist intervention.

“Where risk of misuse, abuse or illicit use is identified, I am satisfied that the risk can be minimised through pharmacist-consumer consultation.”

The TGA Scheduling committee’s interim decision was handed down in June last year. It was backed by both the Pharmacy Guild of Australia and the Australian Medical Association (AMA).

“Melatonin is a safe medicine used for the treatment of insomnia,” said the Guild.

“Patients with primary insomnia will benefit from access to a proven, ARTG-registered product with a better safety profile than alternative prescription-only products such as benzodiazepines, Z-drugs or other Schedule 3 products such as promethazine or doxylamine”.

“We believe that the proposal fits all the criteria for a Schedule 3 medicine. In addition it will harmonise with New Zealand where melatonin has recently been downscheduled.”

I am satisfied that it is substantially safe with pharmacist intervention.—TGA delegate

The AMA said its members agree that melatonin offers a safer alternative to benzodiazepines or sedating anti-depressants for sleep conditions

“Often individuals may use over the counter antihistamines to treat insomnia, despite limited evidence that it is effective,” it said.

“Alternatively, 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.”

The Society of Hospital Pharmacists of Australia (SHPA) said it “supports the down-scheduling of Melatonin, however a maximum quantity should be included”.

An initial implementation date of 1 October 2020 was moved back to 1 June 2021 after industry stakeholders expressed firm objections.

This allowed sufficient time for labelling changes to be made, said the TGA delegate, as well for the development of educational material for pharmacists to promote evidence-based use and facilitate discussions for compliance with the age requirement of 55 years and over.

Please see our CPD articles:

Melatonin—Its role in your life. Part 1: Biosynthesis, regulation, physiology and pharmacology

Melatonin— Its role in your life. Part 2: Clinical use of melatonin for sleep.

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