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news.Results from a phase III clinical study have shown that bedtime administration of Takeda's investigational compound, ramelteon, significantly reduced time to fall asleep in older adults with chronic insomnia.
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A total of 829 older adults (aged 64-93 years) were enrolled in a randomized, double-blind, five-week study. Study participants completed next-morning sleep questionnaires regarding their previous night’s sleep for each night during the study.
Analysis of data from the questionnaires showed that, in comparison to those who received placebo, study participants who received ramelteon 4mg or 8 mg had statistically significant decreases in estimates of time to fall asleep.
In addition, after patients discontinued the use of ramelteon, there was no rebound insomnia, nor did patients exhibit symptoms of withdrawal. The incidence of adverse events for both ramelteon 4mg and 8mg dose groups was comparable with that of placebo.
“We are extremely pleased with the results of this study. We think the data, which showed no rebound insomnia or withdrawal effects, are particularly exciting and may add to the potential for ramelteon to provide another option for older adults living with insomnia,” said Dr Steve Sainati, vice president of clinical research at Takeda Pharmaceuticals North America.