AANP: Ramelteon Reduces Time to Sleep with No Next-Day Hangover

June 25, 2007

INDIANAPOLIS -- Ramelteon reduces mean latency to persistent sleep by 50% or more in a significant percentage of patients when compared with placebo. No significant next-day residual or adverse effects were seen.

INDIANAPOLIS, June 25 -- Ramelteon reduces mean latency to persistent sleep by 50% or more in a significant percentage of patients when compared with placebo, researchers reported here.

No significant next-day residual or adverse effects were seen with the selective MT1/MT2 melatonin receptor agonist, according to study results presented at the American Academy of Nurse Practitioners meeting.

The researchers, employees of Takeda Pharmaceuticals North America, did a post hoc analysis of two clinical registration trials for the medication. The combined analysis included 203 adults ages 18 to 83 with a primary diagnosis of primary insomnia lasting more than three months.

All had a baseline mean latency to persistent sleep of 20 minutes or more as measured by polysomnography. Study medication, either 8 mg of ramelteon or placebo, was administered 30 minutes before bedtime and latency to persistent sleep was recorded for two consecutive nights.

"We found that about 63% of the people showed a reduction of greater than 50% in their initial latency to persistent sleep," said Patrick Maloney, Ph.D., regional scientific manager for Takeda Pharmaceuticals North America. "Only about 44% had the same response on placebo. There was a statistically significant difference (P