Australia's original prolonged-release melatonin now available over the counter at pharmacies

MAIN POINTS

• Circadin^® prolonged-release melatonin is now available without prescription¹
• Circadin^® is clinically proven in people aged 55 and over² to help them fall asleep quicker, sleep better, wake refreshed, and in turn improve quality of life³
• Circadin^® mimics the effect of the body's natural sleep hormone, melatonin²
• Sleep problems are common in Australia, affecting 60% of the population⁴

ASK YOUR PHARMACIST – THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU.

SYDNEY, June 1, 2021 /PRNewswire/ -- Circadin prolonged-release melatonin is now available nationally, over the counter from pharmacists, without a prescription.¹

Australians who may previously have been purchasing melatonin products from overseas to improve sleep will be able to obtain it from their local pharmacy if their pharmacist deems it appropriate for them.

Melatonin is a natural hormone produced in the brain and released by the body every night in response to darkness to help induce and maintain sleep. Its production and release are regulated by the 24-hour day-night cycle known as the circadian rhythm.² Many people think of this cycle as their body clock.

In the past, Australians may have resorted to sourcing melatonin supplements from overseas where they are available without prescription.

"If the country of origin from which some Australians have been purchasing melatonin products does not have the same regulatory excellence as Australia, there is no way to check the products are safe, of a high quality and do what they are supposed to do," said John Bell, Pharmacist Practitioner, Teacher at the Graduate School of Health UTS, Chair of the Australian Self-Care Alliance and former National President of the Pharmaceutical Society of Australia.

Sleep issues are common and can affect all age groups and genders. Indirect costs associated with sleep disorders include $3.1 billion in lost productivity due to premature workforce separation, death,⁵ and absenteeism. The costs related to motor vehicle and workplace accidents amount to $129 million and $517 million respectively.⁵

Age-related sleep changes, such as difficulty falling asleep and increased early morning awakening may be associated with age-related changes in the circadian rhythm.⁶

"Difficulty falling asleep, staying asleep, or having sleep that is not refreshing becomes more common as people age and their natural supply of melatonin depletes," said Mr Bell. 

"Melatonin is considered safe for short-term use. In contrast to many sleep medications, with melatonin people are unlikely to become dependent, have a diminished response after repeated use (habituation), or experience a hangover effect," said Mr Bell.

Circadin^®, is formulated to mimic the natural melatonin release in a person's body and to support the circadian rhythm, which regulates healthy sleep-wake cycles.²

Circadin^® works with the body's natural processes to induce a restful, restorative sleep.² It does so by gradually releasing melatonin in the body over an 8 to 10 hour period,⁷ thereby facilitating the feeling of sleepiness, the ability to fall asleep, and improving sleep quality and next day alertness.³

The over-the-counter availability is for prolonged-release tablets containing 2mg or less of melatonin in packs containing not more than 30 tablets.¹ It is for the short-term treatment of people aged 55 or over and must be dispensed by a pharmacist.¹

"The move for prolonged-release melatonin to be available from pharmacy enables access to a short-term sleep medicine under the management of a pharmacist," said Mr Bell.

ASK YOUR PHARMACIST – THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU.

For more information visit: www.circadin.com.au^[1] 

For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=cmi&q=circadin^[2] 

References

1.     Therapeutic Goods Administration (TGA). 2021. 1.3. Melatonin. [online] Available at: <https://www.tga.gov.au/book-page/13-melatonin^[3]> [Accessed 28 April 2021].

2.     Circadin^® Consumer Medicine Information (January 2021).

3.     Wade AG, Ford I, Crawford G, et al. Efficacy of prolonged release melatonin in insomnia patients aged 55-80 years: quality of sleep and next-day alertness outcomes. Curr Med Res Opin 2007; 23(10): 2597-2605.

4.     Chronic Insomnia Disorder in Australia; A Report to the Sleep Health Foundation, July 2019.

5.     The economic cost of sleep disorders in Australia. Deloitte Access Economics. October 2011.

6.     Zisapel N. Sleep and sleep disturbances: biological basis and clinical implications. Cell Mol Life Sci 2007; 64(10):1174-1186

7.     European Medicines Agency (EMEA). Assessment report for Circadin. Procedure No EMEA/H/C/695. 2007. https://www.ema.europa.eu/en/documents/scientific-discussion/circadin-epar-scientific-discussion_en.pdf^[4] [Accessed 24 September 2019].

References

1. ^{^} www.circadin.com.au (www.circadin.com.au)
2. ^{^} https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=cmi&q=circadin (www.ebs.tga.gov.au)
3. ^{^} https://www.tga.gov.au/book-page/13-melatonin (www.tga.gov.au)
4. ^{^} https://www.ema.europa.eu/en/documents/scientific-discussion/circadin-epar-scientific-discussion_en.pdf (www.ema.europa.eu)