Phase III study results indicate ramelteon significantly reduces time to sleep in adults with chronic insomnia without inducing rebound insomnia or withdrawal effects, according to a presentation at the annual meeting of the American Academy of Neurology.

In this sub-analysis of a large, double-blind, placebo-controlled study, 269 adults were randomized to 8 mg ramelteon or placebo nightly for 35 nights. Sleep parameters were evaluated at weeks 1, 3, and 5 using a polysomnograph. Ramelteon 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).

Results showed that a statistically significantly greater percentage of adults with chronic insomnia treated with ramelteon demonstrated at least 50 percent reduction in latency to persistent sleep compared with people who received placebo at week 1 (63 percent versus 40 percent).Those results were sustained throughout the study (63 percent versus 41 percent at week 3 and 66 percent versus 48 percent at week 5).

The analysis revealed no evidence of rebound insomnia or withdrawal with ramelteon as. 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.

“These data show that ramelteon 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.