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Novel Treatment Offers Insomnia Sufferers Hope Of Quality Sleep
A new, first in class sleep medication is launched, offering hope
for thousands of sufferers of insomnia in Europe. Circadin(R),
sustained-release melatonin, provides natural sleep by increasing the
body's own level of this naturally occurring hormone throughout the night.
(1)
Melatonin is the hormone responsible for regulating the circadian
rhythm (or sleep cycle) and enabling restorative sleep. Circadin(R), the
first melatonin agent approved by the European Medicines Agency (EMEA), is
now available for the treatment of primary insomnia.(1) Circadin(R) is the
first approved sleep treatment to work by ensuring melatonin coverage all
through the night. Unlike existing sleep medications, it is not associated
with problems such as dependency and poor next day functioning.(1),(2)
What is insomnia?
It is estimated that primary insomnia affects 1-10% of the general
population, increasing to up to 25% in the elderly.(3)
Surveys have shown that insomnia can have a negative impact on many
areas of patients' lives, including health, relationships, family life and
work life. Sleep deprivation is associated with psychological disorders,
including depression, decreased immune function and cardiovascular disease.
(4),(5),(6),(7),(8)
Dr Alan Wade, medical director of CPS Research, Glasgow, Scotland said:
"The launch of Circadin(R) marks a huge advance for people that suffer from
insomnia. It's the first treatment that can work in a natural way to
establish restorative sleep with no hangover effects the next day.
Improvement in quality of life and next day functioning are the goals in
treating insomnia, and Circadin(R) delivers on both of these endpoints."
A new treatment paradigm
Traditionally insomnia has been diagnosed on the basis of quantity of
sleep - i.e. how long it takes to get to sleep or how long a person sleeps
for. While it is important not to ignore quantity of sleep, this is a
matter of individual need. What matters to all patients, regardless of the
amount of sleep they need, is quality of sleep. It is the quality of sleep
which results in morning alertness, improved functioning the following day
and better quality of life. Circadin(R) is the first sleep drug with proven
efficacy on all these parameters. (9)
What is melatonin?
Melatonin is a naturally occurring hormone that regulates the circadian
rhythm in humans and animals. It is the signal of night and day, and of
sleep and awake time.(10) Circadian rhythm is often referred to as the
'body clock'. In the evening, the retina of the eye responds to the fading
light and signals a small gland in the brain called the pineal gland to
release melatonin. Melatonin levels peak in the middle of the night, and
then slowly decline until morning, ensuring restorative sleep throughout
the night.(11)
As a person ages, the night-time production of melatonin tends to
decrease, and the levels of melatonin in elderly people with insomnia are
lower than in healthy persons. As the prevalence of insomnia increases with
age, it appears that insomnia in elderly people may be caused by this
reduced melatonin secretion, as opposed to simply age alone.(11), (12),
(13), (14), (15) Circadin(R) mimics this pattern of melatonin release
throughout the night to promote restorative sleep with no evidence of
impairment on next day functioning.(1)
Efficacy of Circadin(R) in clinical trials
Circadin(R) has proved to be an effective treatment in clinical studies
for over 55s with primary insomnia.(16)
The trials showed that almost half of patients taking Circadin(R)
experienced a significant improvement in quality of sleep, and nearly 40%
improved on morning alertness, as measured by the Leeds Sleep Evaluation
Questionnaire.(16)
This is important in the treatment of insomnia because improvements in
sleep quality, rather than quantity, translate into greater improvements to
next day functioning and quality of life(9). In fact 70% of patients
responding to Circadin(R) on both quality of sleep and morning alertness
reported a significant improvement in quality of life as measured by the
WHO-5 well-being scale.(3)
Other study endpoints included sleep latency (or time to get to sleep),
and a clinically significant reduction in time was found in the Circadin(R)
group, similar to that of traditional sleep medications.(3)
Circadin(R) mode of action avoids side effects associated with
traditional sleep treatments(3)
Current sleep treatments have been associated with adverse reactions
such as daytime sedation (or 'hangover'), impaired memory, driving skills
and concentration. Furthermore, abrupt withdrawal of benzodiazepine
hypnotics is associated with a return of insomnia worse than before
(rebound insomnia), and they are also known to carry a risk of dependency.
(13),(5)
Clinical studies with Circadin(R) have not shown any risk of rebound
insomnia nor any impairment on memory or psychomotor functioning at any
point after dosing.(1)
Circadin(R) has a positive safety profile and in clinical studies the
incidence of adverse events with Circadin(R) was low and even less than
with placebo.(2) Adverse effects were generally mild and infrequent and
those reported included headache, sore throat, back pain and generalised
feelings of weakness.(1)
June Fraser, a former insomnia sufferer who was involved in the
Circadin(R) clinical trials said, "Insomnia was a huge burden on my family,
home and work life, but traditional therapies often made me feel worse than
missing a night's sleep. Circadin(R) helped me to get back into a natural
sleep rhythm and have refreshing sleep. Being able to get up in the
morning, feeling refreshed, feels like a weight has been lifted from my
shoulders."
About insomnia
Insomnia is the most common sleep disorder and is characterised by
difficulty falling asleep or difficulty in maintaining sleep resulting in
poor next day functioning.(4) It is estimated that between 30 and 45%
percent of the world's population suffers from insomnia.(4) The condition
can present as primary or secondary insomnia. Secondary insomnia occurs
when a physical or mental condition or problem causes an inability to sleep
(for example pain, anxiety); primary insomnia is where no other reason for
the condition is identified. The prevalence of primary insomnia increases
with age and affects up to 25 percent of the elderly population.(4) The
increase in prevalence is associated with the decrease in melatonin that
occurs with age.
About Circadin(R)
Circadin(R) was approved via the central procedure of the European
Commission on 29th June 2007, and 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. Circadin(R) is the approved
trade name in the whole EU. Lundbeck holds commercialisation rights to
Spain, Germany, UK, Italy, France, Ireland, Portugal, Poland, Hungary,
Romania, Czech Republic, Slovak Republic, Slovenia, Bulgaria, Cyprus, Malta
and Liechtenstein, representing 75% of the market potential in Europe.
Lundbeck also holds exclusive rights to commercialise Circadin(R) in Asia,
Latin America and other major markets such as Australia and Turkey.
Following regulatory filing and approval Lundbeck expects to market
Circadin(R) in the first markets outside of Europe in 2009.
Nycomed holds the commercialisation rights to the remaining markets in
Europe. At the end of February 2008, Circadin(R) had been launched by
Nycomed in Austria, Belgium, Denmark, Estonia, Finland, Greece, Iceland,
Latvia, Lithuania, and Norway.
About Lundbeck
H. Lundbeck A/S 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. In 2006, the
company's revenue was DKK 9.2 billion (approximately EUR 1.2 billion or USD
1.6 billion). The number of employees is approximately 5,300 globally. For
further information, please visit http://www.lundbeck.com .
References
1. Circadin(R), Summary of Product Characteristics
2. Tyrer P, Murphy S, Riley P. The benzodiazepine withdrawal symptom
questionnaire. J Affect Disord 1990; 19: 53-61.
3. Wade et al. Prolonged-release melatonin for the treatment of
insomnia: Targeting quality of sleep and morning alertness. Ageing Health
2008; 4(1): 11-21
4. Leger D, Poursain B, Neubauer D et al. An international survey of
sleeping problems in the general population. Curr Med Res Opin 2008; 24(1):
307-317
5. Taylor DJ, Lichstein KL, Durrence HH. Insomnia as a health risk
factor. Behav Sleep Med 2003; 1: 227-247
6. Ohayon MM, Zulley J. Correlates of global sleep dissatisfaction in
the German population. Sleep 2001; 24: 780-787
7. Okuji Y, Matsuura M, Kawasaki N et al. Prevalence of insomnia in
various psychiatric diagnostic categories. Psychiatry Clin Neurosci 2002;
56: 239-240
8. Katz DA, McHorney CA. Clinical correlates of insomnia in patients
with chronic illness. Arch Intern Med 1998; 158: 1099-107
9. Wade et al. Efficacy of prolonged release melatonin in insomnia
patients ages 55-80 years: quality of sleep and next day alertness. Curr
Med Opin 2007:23(10); 2597-2605
10. Zisapel et al. Sleep and sleep disturbances; biological basis and
clinical implications. Cell Mol Life Sci 2007; 64: 1174-1186
11. Lewey et al. Light suppresses melatonin secretions in humans.
Science 1980; 210(4775): 1267-1269
12. Haimov I, Laudon M, Zisapel N et al. Sleep disorders and melatonin
rhythms in elderly people. BMJ 1994; 309(6948): 167
13. Waldhauser F, Weiszenbacher G, Tatzer E et al. Alterations in
nocturnal serum melatonin levels in humans with growth and aging. J Clin
Endocrinol Metab 1988; 66(3): 648-652
14. Zeitzer JM, Daniels JE, Duffy JF et al. Do plasma melatonin
concentrations decline with age? Am J Med 1999; 107(5): 432-436
15. Corman B, Leger D. Sleep disorders in elderly. Rev Prat 2004;
54(12): 1281-1285
16. Lemoine et al. Prolonged release melatonin improves sleep quality
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withdrawal effects. J Sleep Res 2007; 16: 372-380
Lundbeck
http://www.lundbeck.com
Novel Tratamentul Oferte Insomnie suferinzi de speranta de calitate Sleep - Novel Treatment Offers Insomnia Sufferers Hope Of Quality Sleep - articole medicale engleza - startsanatate