ROZEREM (ramelteon) Showed Significant Reduction in Time to Fall Asleep
Sleep and Insomnia
With no evidence of rebound insomnia or withdrawl effects
Results of a sub-analysis from a Phase III clinical study showed that ROZEREMTM (ramelteon) significantly reduced time to fall asleep in adults with chronic insomnia and showed no evidence of rebound insomnia or withdrawal effects. The results were presented today at the 2006 Annual Meeting of the American Academy of Neurology.
In this placebo-controlled analysis, approximately two-thirds of patients who received 8 mg of ROZEREM experienced at least a 50 percent 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.
"These data show that ROZEREM can be effective in helping patients fall asleep faster without rebound insomnia and other withdrawal effects," said Thomas Roth, PhD, director of the Sleep Disorders and Research Center, Detroit, Mich. "This may represent another option for patients who are looking for a sleeping medication that is right for them."
About the Study
In this sub-analysis of a large, double-blind, placebo-controlled study, a total of 269 adults received 8 mg of ROZEREMTM (n=138) or placebo (n=131) nightly for five weeks (35 nights). Sleep parameters were evaluated at weeks 1, 3, and 5 by using a polysomnograph. ROZEREM was replaced with placebo for the two nights following the study (nights 36 and 37) to evaluate rebound insomnia and withdrawal effects.
The primary endpoint was the percentage of patients who achieved at least 50 percent improvement in the time it took to fall asleep (latency to persistent sleep, or LPS).
Results showed that a statistically significantly greater percentage of adults with chronic insomnia treated with ROZEREM 8 mg demonstrated at least 50 percent LPS reduction compared to those who received placebo at week 1 (63 percent vs. 40 percent (P<0.001)).
Those results were sustained throughout the study (63 percent vs. 41 percent at week 3 (P<0.001); 66 percent vs. 48 percent at week 5 (P<0.005)).
The analysis revealed no evidence of rebound insomnia or withdrawal for patients taking ROZEREM as measured by the BWSQ. Adverse events were similar in both groups, with somnolence, fatigue and headache being the only events reported in 5 percent or more of patients in either group. This incidence was similar to that seen in other clinical studies.
"It is estimated that about 60 million people in the U.S. struggle with symptoms of insomnia, and this is even more significant as we learn more about the relationship between sleep disorders and other medical conditions, and the consequences of poor sleep. In this analysis of chronic insomnia patients, it was shown that approximately two-thirds had their sleep onset time cut in half