Primary Insomnia Clinical Trial
Official title:
A Double-blind, Parallel Group, Randomised, Placebo Controlled Study of Efficacy and Safety of Circadin® 2 mg in the Treatment of Insomnia Patients With Low Endogenous Melatonin
This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.
Studies throughout the world have shown that insomnia is a common complaint that occurs in
10-50% of the population depending on age, sex and country. Among the wide variety of
available treatments of sleep disturbances, the most commonly prescribed hypnotics are the
benzodiazepines (BZD) and non-BZD hypnotics.
However, these hypnotics were often associated with rebound, dependency, tolerance, higher
risk of falls mainly in the elderly population, anterograde memory disturbances and increased
risk for motor accidents the next day.
In response to the unmet clinical need for a safe and efficacious alternative treatment for
primary insomnia, that in addition to treating quantitative sleep problems, would improve
sleep quality and daytime functioning, a clinical development program on melatonin for the
treatment of primary insomnia was initiated.
This study is conducted using a randomised, double-blind, placebo controlled parallel group
design, after a single-blind placebo period. Primary insomnia patients aged 18-80 will be
screened for entry into the study.
After the initial 3 weeks double-blind treatment period, patients will be given the option to
enter a six-month double-blind continuation study.
Primary parameter is sleep latency, secondary parameter is sleep maintenance. Exploratory
parameters are total sleep time, sleep quality, morning alertness and quality of life.
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