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news.Results of a sub-analysis from a phase III clinical study have shown that Takeda's Rozerem significantly reduced time to fall asleep in adults with chronic insomnia and showed no evidence of rebound insomnia or withdrawal effects.
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In this placebo-controlled analysis, approximately two-thirds of patients who received 8mg of Rozerem experienced at least a 50% reduction in the time it took them to fall asleep. Study participants also experienced no rebound insomnia or withdrawal effects following discontinuation of treatment with Rozerem. Rebound insomnia is the worsening of insomnia symptoms after a person stops taking their insomnia medications.
The results were presented at the 2006 annual meeting of the American Academy of Neurology.
“These data show that Rozerem can be effective in helping patients fall asleep faster without rebound insomnia and other withdrawal effects,” said Dr Thomas Roth, director of the Sleep Disorders and Research Center, Detroit. “This may represent another option for patients who are looking for a sleeping medication that is right for them.”
Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence in clinical studies, and as a result, has not been designated as a controlled substance.