GPs Can Now Offer A New Prescription-only Melatonin For Older Adults With Primary Insomnia, UK

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Primary Care / General Practice;  Regulatory Affairs / Drug Approvals
Article Date: 06 Jun 2008 - 1:00 PDT

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GPs can now offer a melatonin on prescription to treat older adult patients diagnosed with primary insomnia. Circadin(R) is the first pharmaceutical grade licensed melatonin available for the short-term treatment of primary insomnia in patients aged 55 years or over.1

Circadin is a prolonged-release formulation of synthesised melatonin that is released over several hours 1, in order to provide the body with melatonin at an adequate physiological level during the normal hours of resting. It can therefore be offered as a first logical treatment option, alongside sleep hygiene advice, for older adult patients with primary insomnia.

Dr Alan Wade, a GP and clinical researcher from Glasgow with a specific interest in sleep and insomnia, commented on the introduction of this new licensed regulator of physiological sleep: "The key to managing primary insomnia is to restore the quality of sleep, rather than the quantity of sleep. Changes occur in the full sleep cycle with age and part of this could be due to a correlation between increasing age and declining levels of melatonin. Treatment with Circadin, as an exogenous melatonin, may replenish that deficiency and restore the normal sleep cycle for restful, restorative sleep and normal next-day functioning."

Primary insomnia disrupts daily life, resulting in clinically significant distress and impairment of social, occupational and daily functioning. 2 The WHO also includes primary insomnia in the overall cohort of neuropsychiatric conditions that contribute to overall burden of disability.* 3,4

A survey into the impact primary insomnia has on quality of life has shown that over a third of people feel sleepy at work everyday, or on most days, and 29% feel that insomnia has affected their relationship with their partner.5 Treatment with Circadin has been shown to significantly improve quality of sleep (QOS) and behaviour following wakening (BFW), also referred to as next day-functioning, and both contribute to improved quality of life. 6,7

Circadin is effective within three weeks of dosing, and helps to induce and maintain sleep. 6 It will be available as a 21-day short course treatment.

Developed in collaboration between sleep experts and Lundbeck UK, 'Sleep Advice for Adults with Insomnia' is a sleep hygiene resource for healthcare professionals to use with their patients, and is available to download at http://www.sleepadvice.co.uk/hcp. A downloadable patient leaflet and sleep diary to give to patients is available at http://www.sleepadvice.co.uk/public.

*Defined as DALY - a measure calculated as the sum of years lost due to premature mortality and equivalent 'healthy' years lost due to disability 4

Notes

- Insomnia is a recognised "sleep disorder". It is characterised by poor sleep quality with difficulty in initiating and maintaining sleep, and these difficulties last for at least one month.2 Insomnia can be either "primary" or "secondary". In primary insomnia the disturbance is not attributed to another mental health disorder, substance use or general medical condition, as is the case in secondary insomnia. 8

- Recent data have shown that up to 37% of patients presenting at general practices in the UK have insomnia. 9

- Circadin is a 2mg prolonged-release tablet and is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. 1 Circadin is generally well tolerated and clinical trials reported no evidence for treatment related withdrawal symptoms or rebound insomnia.6,7

- Lundbeck is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. Lundbeck's portfolio includes therapies for depression and anxiety, schizophrenia, Alzheimer's and Parkinson's disease. In 2007, the company's revenue was DKK 11 billion (approximately EUR 1.5 billion or USD 2.0 billion). The number of employees is approximately 5,300 globally. For further information, please visit http://www.lundbeck.com

References

1. Circadin Summary of Product Characteristics

2. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, DSM-IV-TR (text revised) http://www.psychiatryonline.com/index.aspx

3. World Health Organisation Regional Office for Europe. Highlights on health, United Kingdom 2004 see here.

4. The WHO Global Burden of Disease study (GBD 2000)

5. A study on the incidence and impact of insomnia among 55-70 year olds. Kember Associates. April 2008

6. Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. Lemoine P, et al. J. Sleep Res 2007; 16: 372-380

7. Efficacy of prolonged release melatonin in insomnia patients aged 55-80 years: quality of sleep and next-day alertness outcomes. Wade AG, et al. Current Medical Research and Opinion. 2007; 23(10): 2597-2605

8. Global Burden of Disease (GBD) Study 2000-2002: GBD sequelae and case definitions

9. Epidemiology of insomnia: a longitudinal study in a UK population. Morphy, H., K. M. Dunn, et al. Sleep (2007), 30(3): 274-80

http://www.lundbeck.com