Circadin® is a prolonged-release 2mg melatonin formulation which, when taken before bedtime, mimics the physiological pattern of the endogenous hormone excreted during the night. It was approved by the EU-EMEA in June 2007 for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 or over. Placebo controlled clinical trials demonstrated, beyond the shortening of sleep latency seen with traditional hypnotics, concomitant improvements in sleep quality and next day alertness and subsequently, quality of life. In contrast to traditional sedative hypnotics, CircadinR has shown no evidence of impairing cognitive and psychomotor skills, of rebound, dependence or abuse potential and no significant adverse events compared to placebo. It can be used concomitantly with most medications but may potentiate the effects of GABA-A receptor modulators. Analyses presented here show that Circadin® has comparable efficacy and safety in patients with and without history of hypnotic drug use.
|Number of pages||5|
|State||Published - May 2009|