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Ramelteon safe, effective in treatment of insomnia among women in multiple clinical trials

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
Ramelteon appears to effectively reduce latency to persistent sleep (LPS) among women with chronic insomnia without major side effects, new data reveal.

Researchers conducted 2 separate post-hoc analyses on data from a total of 250 women in 2 double-blind, placebo-controlled trials of ramelteon. The first trial was a short-term, 2-night crossover study (median age, 36 years) and the second trial was a longer-term, 5-week parallel study (median age, 39 years). All patients had a diagnosis of primary insomnia lasting more than 3 months with LPS of at least 20 min, as measured by polysomnography for 2 consecutive nights, and were administered ramelteon 8 mg or placebo 30 minutes before bedtime.

An adverse events analysis was also conducted using data from women (median age, 49 years) who were enrolled in 18 separate clinical trials that compared ramelteon 8 mg with placebo.

In the short-term study, patients who received ramelteon had a mean LPS of 24.6 min compared with 40.2 min for patients who received placebo (P<.001).

In the longer-term study, patients who received ramelteon had a mean LPS of 30.1 min compared with 45.6 min among patients who received placebo (P<=.001) at week 1. This significant difference in mean LPS was also observed at week 3 (P=.012) and week 5 (P=.028).

In the adverse events analysis, headache was the only event that occurred in more than 5% of patients who received ramelteon 8 mg or placebo (8.1% vs 8.1%, respectively). Less frequent adverse events included somnolence (4.9% vs 2.6%), nausea (4.3% vs 3.2%), dizziness (4.7% vs 3.7%), fatigue (3.8% vs 2.2%), and exacerbated insomnia (3.8% vs 2.0%).

"Ramelteon is an effective and well-tolerated treatment for women with chronic insomnia," the authors concluded. "The overall adverse event profile of ramelteon 8 mg across multiple clinical trials was comparable to placebo in all female subjects."

Ramelteon is the only melatonin receptor agonist currently approved by the Food and Drug Administration to treat insomnia. (Mini LJ, et al. Poster NR608.)

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