Australian first: GPs and their patients set to benefit from a recent class of insomnia treatment

Doctors and their patients are set to benefit this month from the release of Circadin (prolonged release melatonin). The first melatonin receptor agonist to be registered in Australia, Circadin provides prolonged release melatonin to improve sleep quality and morning alertness with no dependence1 or withdrawal.1,4

Circadin is a prescription-only monotherapy for the short term treatment (up to three weeks) of primary insomnia characterised by poor quality of sleep in patients who are aged 55 years and over.³

"As people age it has been suggested the production of melatonin, a hormone which helps regulate the sleep-wake cycle, declines and the prevalence of sleep disorders increase, particularly insomnia," said Dr Philip Morris, psychiatrist and specialist in the mental health of older adults, Gold Coast.

Sleep disorders have a significant burden on the community and on primary care in particular. Approximately 50 percent of older people report insomnia and an overall dissatisfaction with quality of sleep,^1,5 making insomnia one of the most common health conditions managed by Australian GP surgeries.⁶

Circadin significantly improves sleep onset latency compared with placebo as measured by the Pittsburgh Sleep Quality Index (P =0.028), and was similar to most frequently used sleep medications.²

"Sleep is restorative both mentally and physically, as it improves overall quality of life by renewing energy and motivation," said Dr Morris. "For doctors treating patients, it is thus important that any sleep medication effectively addresses a number of requirements, including patient tolerability, sleep onset, sleep quality and morning alertness."

Sleep medications such as hypnotics and sedative antidepressants address insomnia in relation to sleep quantity, but not necessarily sleep quality.^1,4 As a result, no improvement in morning alertness or daytime vigilance has ever been claimed or demonstrated for any of these treatments.²

Circadin is the first drug shown to significantly improve quality of sleep and morning alertness in insomnia patients aged ≥ 55 years, leading international experts to conclude it has a beneficial treatment effect on the restorative value of sleep.^1,2 In a randomised, double-blind, placebo-controlled multicentre study, nearly half of Circadin patients (47 percent vs. 27 percent in the control group; p<0.01) improved concomitantly in quality of sleep and morning alertness;¹ and over half of Circadin patients (55 percent vs. 39 percent in the control group; p=0.029) reported on improvement in changes of sleep quality.¹ Another study found patients who responded to Circadin were nearly three times as likely to experience clinically relevant improvement in quality of life (as measured by the WHO-5 Wellbeing Index) compared with non-responders (70 vs. 24 percent respectively; p=0.034).²

Importantly, Circadin has a similar side effect profile to placebo treatment, resulting in it being well tolerated with no obvious difference in safety parameters (including withdrawal).^1,2,4 In addition, Circadin has been shown to have no impact on rebound insomnia, with sleep parameters returning to their baseline values after cessation of three weeks of active treatment.⁴

In comparison, hypnotics have been associated with a range of safety issues including dependence, rebound insomnia,⁴ and impairment of psychomotor functions, memory recall and driving skills.²

"Traditionally doctors and their patients have had concerns about dependency and tolerability of hypnotic medication. Short term use of Circadin does not appear to lead to dependence or withdrawal complications," said Ron Grunstein, Professor of Sleep Medicine at the Woolcock Institute of Medical Research, University of Sydney.

Sleep issues such as insomnia can significantly affect a person’s psychosocial, physical and occupational functioning. Patients can experience mood disturbances, decreased problem solving skills, lowered mental alertness, drowsiness and inability to concentrate as a result of insomnia.⁷ From a work perspective, the largest proportion of economic costs associated with insomnia concern insomnia-related work absences and reduced productivity.⁸

"Sleep disorder is a common and distressing condition," said Dr Morris. "The introduction of a prolonged release melatonin treatment in Australia gives doctors the option of prescribing a treatment which targets an underlying cause of insomnia. I encourage healthcare professionals to consider which of their patients may benefit from this new treatment."

Circadin is available via prescription and costs approximately $32.00 for a pack of 21 tablets (approximately $1.50 per day). Relevant patients should take one Circadin tablet daily by mouth, after food, one to two hours before bedtime as required for three weeks.³

References

Lemoine P, Nir T, Laudon M, et al. Prolonged release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. J Sleep Res. 2007;16:372-380.
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)23:2597-2605.
Product Information: Circadin Prolonged Release Tablets. Croydon, VIC: Sigma Pharmaceuticals (Australia) Pty Ltd; 15 December 2009.
Luthringer R, Muzet M, Zisapel N, Staner L. The effect of prolonged-release melatonin on sleep measures and psychomotor performance in elderly patients with insomnia. Int Clin Psychopharmacol. 2009;24(5)239-49.
Kamel NS, Gammack JK. Insomnia in the elderly: Cause, approach, and treatment. Am J Med. 2006;119(6):463-9.
Australian Institute of Health and Welfare. Chronic Disease Indicators Database (00174) [online]. 2010 [cited March 2010]. Available from URL: http://www.aihw.gov.au/cdi/cdi_njs/index.cfm?DisplCommand=IndDisplay&IndId=174
Reach Out Australia (an initiative of Inspire). Fact Sheet: Insomnia [online]. Inspire Foundation; 27 June 2009 [cited March 2010]. Accessed from URL: http://au.reachout.com/find/articles/insomnia
Daley M, Morin CM, LeBlanc M, et al. The economic burden of insomnia: Direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep. 2009;32(1):55-64.