Prolonged-release melatonin for the treatment of insomnia in patients over 55 years.
BACKGROUND
Clinical data show that poor quality, rather than quantity, of sleep corresponds negatively to measures of health, well-being and satisfaction with life. However, until now treatment of insomnia has primarily targeted quantity of sleep. PR (prolonged release)-melatonin offers a new treatment option in insomnia.


OBJECTIVE
To provide an overview of PR-melatonin, the first melatonin receptor agonist to be granted marketing authorisation in Europe as monotherapy for the treatment of primary insomnia in patients aged > 55 years.


METHODS
Review data published in peer review journals and the EMEA (European Medicines Agency) website.


CONCLUSIONS
PR-melatonin significantly improves morning alertness and quality of sleep compared with placebo. There are no safety concerns.
Wade
Alan
A
CPS Research, 3 Todd Campus, West of Scotland Science Park, Glasgow, G20 0KA, Scotland. alangwade@fastmail.fm
Downie
Susan
S
D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations; D006801:Humans; D008550:Melatonin / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D008875:Middle Aged; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*
D003692:Delayed-Action Preparations; D008550:Melatonin