Takeda's melatonin (MT1/MT2) receptor agonist ramelteon (11) was approved and launched in 2005 in the U.S., indicated for the treatment of primary insomnia characterized by difficulty with sleep onset. It is the first prescription medication for insomnia with a novel mechanism of action to reach the US market in 35 years. It is also the first and only prescription sleep medication that has not exhibited potential for abuse and dependence, and as such is not designated as a scheduled substance by the DEA. Moreover, ramelteon was also filed in late March 2007 in E.U. for primary insomnia.
In controlled clinical trials in patients with primary insomnia, ramelteon 4-32 mg demonstrated significant reduction in latency to persistent sleep (LPS) compared with placebo. In elderly patients, objective and subjective LPS were also reduced at doses of 4 and 8 mg. Data on total sleep time are more variable,
depending on the clinical trial evaluated, but significant improvements are reported at 4 and 8mg . Most common adverse effects noted to date appear minor, i.e., headache (7%), dizziness (5%) and somnolence (5%). The last published clinical trials evaluated the potential effects of ramelteon 16 mg on apenic and hypopneic events in individuals with obstructive sleep apnea, due to the lack of depressant effects on nervous system, demonstrating no worsening of sleep apnea .
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