Efficacy of prolonged release melatonin in insomnia patients aged 55–80 years: quality of sleep and next-day alertness outcomes

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Abstract
Objective: Melatonin, the hormone produced nocturnally by the pineal gland, serves as a circadian time cue and sleep-anticipating signal in humans. With age, melatonin production declines and the prevalence of sleep disorders, particularly insomnia, increases. The efficacy and safety of a prolonged release melatonin formulation (PR-melatonin; Circadin 2 mg) were examined in insomnia patients aged 55 years and older.Design: Randomised, double blind, placebo-controlled.Setting: Primary care.Methodology: From 1248 patients pre-screened and 523 attending visit 1, 354 males and females aged 55–80 years were admitted to the study, 177 to active medication and 177 to placebo. The study was conducted by primary care physicians in the West of Scotland and consisted of a 2‐week, single blind, placebo run-in period followed by a 3‐week double blind treatment period with PR-melatonin or placebo, one tablet per day at 2 hours before bedtime.Main outcome measures: Responder rate (concomitant improvement in slee...

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