MELATONIN FOR INSOMNIA: SAFETY CONCERNS.
A recent article in the Journal of the American Medical Association raises concerns about widespread use of melatonin in the USA, particularly in children. The article draws attention to the strong possibility that long term and/or high dose use could have unwanted effects including interfering with onset and progression of puberty. I recommend reading the original article for a much more complete account than I can provide here. Link provided at the end of this post.
Melatonin is a neurohormone naturally produced by the brain’s pineal gland. It has a crucial role in regulating sleep in response to the brain’s ‘circadian clock’ interacting with the timing of exposure to light and darkness. When taken as a drug by mouth it can be helpful, if wisely used, in a number of conditions, including REM Sleep Behaviour Disorder (RBD), and Chronic Sleep Onset Insomnia associated with ADHD in children. Research on indications for its use is ongoing, but most of this is relatively recent and limited.
Part of the issue in the US is that melatonin is freely available ‘Over the Counter (OTC)’, without guidance from a medical practitioner or pharmacist. In the US and Europe it is classified as a ‘food supplement’ and is minimally regulated. In Australia, New Zealand and the UK it is classified, correctly in my opinion, as a drug. In Australia it is only available on a prescription or with pharmacist advice and certain indications (see below).
In Australia however it is available online and by post. One online site promotes their melatonin containing product as “100% drug free”. Several suppliers provide melatonin formulations for children, including “gummies”- essentially lollies containing melatonin. The websites I found did not warn about possible adverse effects or about keeping the drug out of reach of children
The JAMA article makes several other important points: (1) a Canadian study “found that the melatonin content was as much as 478% higher than the label indicated in some [OTC] products and could fluctuate substantially between lots’. (2) Between 2012 and 2021 US poison control centers reported that 4097 children were hospitalized, having taken melatonin. Of these, 287 needed intensive care, 5 required mechanical ventilation and 2 died.
The Australian Therapeutic Drug Administration has authorised Circadin, a long acting formulation of melatonin, to be available by prescription and, since June 2021, from pharmacists after assessment by and discussion with the pharmacist (not on shelves in the pharmacy). The conditions under which the pharmacist may dispense Circadin are that the customer should be older than 55, and have ‘primary insomnia’: that is, not insomnia due to conditions such as a major depressive disorder , generalised anxiety disorder, alcohol or other drug use, Restless Legs Syndrome or a number of other conditions. Aspen pharmaceuticals has provided an educational online course for pharmacists.
JAMA article: Climbing Melatonin Use for Insomnia Raises Safety Concerns
https://jamanetwork.com/journals/jama/fullarticle/2794924?guestAccessKey=f16d7daf-b8f0-46d8-ba45-11d2115531f2&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jama&utm_content=olf&utm_term=072722&fbclid=IwAR1DfN-2i8QAXIODZGNalecrj98RGBtYFuLPvrkB_ZPrBWhmCUcwH0AIEOU