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Circadin ® (prolonged release melatonin) licence extended to include treatment for up to 13 weeks¹ in patients with primary insomnia.



Circadin is approved for longer use in patients with primary insomnia, aged 55 years or over.1 Following an extension to its current licence, doctors can now prescribe Circadin for a period of up to 13 weeks, if required.1

In a study evaluating treatment of primary insomnia with prolonged-release melatonin, a subgroup of Circadin patients aged between 55 and 80 years fell asleep significantly more quickly at 13 weeks vs. placebo (p=0.007).2,3

The 13 week licence extension supports the findings that the tolerability profile for Circadin was similar up to and beyond 3 weeks of treatment.3-5 Circadin has shown no association with discontinuation effects (e.g. rebound effects or withdrawal symptoms).3-5

In a previous short-term study nearly half (47%) of patients taking Circadin over 3 weeks experienced clinically relevant improvements in both quality of sleep and morning alertness vs. 27% on placebo (p<0.01).4 This is an important result for the treatment of insomnia because improvements in sleep quality, rather than quantity, translate into greater improvements to next day functioning and quality of life.5 In a separate study, 70% of responders* showed a clinically relevant improvement in quality of life vs. 24% non-responders after 3 weeks treatment with Circadin.5

*Responder is defined as a patient who demonstrated concomitant improvements in Quality of Sleep (QoS) and Behaviour Following Wakening (BFW) on the Leeds Sleep Evaluation Questionnaire (LSEQ).5

‘Sleep Advice for Adults with Insomnia' is a sleep hygiene resource developed in collaboration between sleep experts and Lundbeck UK, for healthcare professionals to use with their patients, and is available to download at www.sleepwelllivewell.co.uk.

A downloadable patient leaflet and sleep diary to give to patients is available at www.sleepwelllivewell.co.uk.

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- ENDS -

Notes to editors:

About insomnia

• Insomnia is a recognised sleep disorder. It is characterised by poor sleep quality with the following factors:6,7

o A difficulty in initiating or maintaining sleep, or non-restorative sleep

o Difficulties last for at least one month

o Clinically significant distress

o Impairment of social, occupational and other important areas of daytime functioning

• Insomnia can be defined into two categories, either ‘primary' or ‘secondary'. In primary insomnia the disturbance is not attributed to another mental health disorder, substance use or general medical condition, as in the case of secondary insomnia.6

About Circadin

• 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. 3-5

• Treatment can be continued for up to 13 weeks.1,2,3

About Lundbeck

• 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, sleep disorders, Alzheimer's and Parkinson's disease. For further information, please visit www.lundbeck.com

This is a promotional feature article that has been produced by Lundbeck Ltd.

Prescribing information

Circadin

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