Ramelteon is a melatonin receptor agonist. According to the manufacturer, its molecular structure is composed of a substituted tetrahydroindenofuran derivative containing a propionamide moiety with one chiral center, and the compound is produced as the (S) enantiomer. It is freely soluble in organic solvents and is considered very slightly soluble in water or aqueous buffers [...]
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 [...]
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 [...]
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 [...]
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 [...]