Adults

The recommended dose of ramelteon is 8 mg, taken within 30 minutes of bedtime. Ramelteon should not be taken with, or immediately after, a high-fat meal because of the delay in absorption.

Elderly Patients

No overall differences in safety or efficacy were observed between elderly and younger adult subjects. In a phase 3 study of elderly patients with chronic insomnia conducted by Roth and colleagues, patients aged 65 to 83 years demonstrated no significant adverse events and no evidence of next-morning psychomotor or memory impairment.

Dosing of ramelteon in this phase 3 study ranged from 4 mg to 8 mg daily.

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The adverse drug events (ADEs) associated with ramelteon appear to be minor and similar to those of placebo. Of the 3,594 subjects evaluated in the phase 1 to phase 3 studies of ramelteon, the most frequent ADEs leading to discontinuation were somnolence (0.8%), dizziness (0.5%), nausea (0.3%), fatigue (0.3%), headache (0.3%), and insomnia (0.3%). Of those patients receiving ramelteon 8 mg in studies, only 3.8% discontinued therapy because of ADEs.

No significant changes in laboratory values, electrocardiograms (ECG), or blood and urine analyses have been reported in clinical trials. The drug has been associated with effects on the reproductive system in adults. Patients experiencing unexplained amenorrhea, galact-orrhea, decreased libido, or problems with fertility should be assessed for alterations in testosterone levels or increased prolactin.

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A double-blind study by Roth and colleagues evaluated the efficacy of ramel-teon in treating transient insomnia in healthy adults ranging from 35 to 60 years of age. Subjects received 16 mg, 64 mg, or placebo 30 minutes before bedtime. The study enrolled 375 patients from 14 sleep research centers in the U.S. The investigators used the “first night effect” model, which is characteristic of transient insomnia; this refers to insomnia that often occurs when someone is assessed in a sleep laboratory.

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INTRODUCTION

Over the past decade, drug companies have focused much of their attention on addressing the problem of insomnia. This effort should come as no surprise— insomnia is being reported at an alarmingly high rate. In 2005, the National Sleep Foundation, part of the National Institutes of Health, estimated that more than half (54%) of all Americans were reporting symptoms of insomnia a few nights a week, and one third (33%) were reporting symptoms nearly every night.

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