Ramelteon Promotes Sleep in Patients with Chronic Insomnia

From the American Academy of Neurology

SAN DIEGO—Ramelteon (Rozerem), which was approved last year for the treatment of insomnia, can significantly reduce the time it takes adults with chronic insomnia to fall asleep, apparently without any untoward side effects, according to new data presented at the 2006 Annual Meeting of the American Academy of Neurology.

Results of a new subanalysis of data from a large, phase 3, double-blind, placebo-controlled clinical study showed that approximately two thirds of patients who received 8 mg/day of ramelteon experienced at least a 50% reduction in the time it took them to fall asleep.

This analysis included 269 adults with chronic insomnia who received 8 mg of ramelteon (n = 138) or placebo (n = 131) nightly for 5 weeks (ie, 35 nights). Sleep parameters were evaluated at weeks 1, 3, and 5 using polysomnography. Ramelteon was replaced with placebo for the last 2 nights of the study (nights 36 and 37) to evaluate for rebound insomnia and withdrawal effects.

The primary end point was the percentage of patients who achieved at least a 50% improvement in latency to persistent sleep.

Results showed that a significantly greater proportion of patients treated with ramelteon 8 mg demonstrated at least a 50% reduction of latency to persistent sleep at week 1 compared with those who received placebo (63% vs 40%, respectively). Results were sustained throughout the study—63% versus 41% at week 3 and 66% versus 48% at week 5, respectively.

“These data show that ramelteon can be effective in helping patients fall asleep without rebound insomnia and other withdrawal effects,” said Thomas Roth, PhD, director, 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.”

Adverse events were similar in both groups, with only somnolence, fatigue, and headache reported by ≥5% of patients in either group, an incidence similar to that seen in other clinical trials.

Ramelteon has a unique therapeutic mechanism of action that selectively targets 2 receptors located in the brain’s suprachiasmatic nucleus (SCN). The SCN is referred to as the body’s “master clock,” because it regulates circadian rhythms, including the sleep-wake cycle.