Efficacy and safety of ramelteon in Japanese adults with chronic insomnia: a randomized, double-blind, placebo-controlled study

Abstract

This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of ramelteon 4 and 8 mg in Japanese adults with chronic insomnia. A secondary objective was to evaluate efficacy and safety when doses were uptitrated from placebo, ramelteon 4 and 8 mg to 4, 8 and 16 mg, respectively. Patient-reported sleep data were collected using sleep diaries. There was no statistically significant difference between ramelteon and placebo in the change in subjective sleep latency (sSL) in the full analysis set (n = 1130). Significant improvement was observed in the change in subjective total sleep time with ramelteon 8 mg at week 1. In post hoc analyses, ramelteon 8 mg reduced sSL in individuals with smaller fluctuations (within ±30 min) of sSL at baseline, in those with a shorter (<1 year) history of insomnia and in individuals who had not used benzodiazepines. Ramelteon up to 16 mg nightly was safe and well tolerated.

Keywords::

• insomnia
• melatonin
• patient-reported sleep data
• ramelteon
• sleep latency
• total sleep time

Acknowledgements

We would like to express our sincere appreciation to the investigators and study sites for their participation and thoughtful advice during the conduct of the study. Editorial assistance was provided by Caroline McGown PhD, Content Ed Net.

Financial & competing interests disclosure

This clinical study was supported by a financial grant from Takeda Pharmaceutical Co., Ltd., Osaka, Japan. Makoto Uchiyama has disclosed receipt of lecture fees from Takeda Pharmaceutical, Astellas Pharma, Meiji Seika Kaisha, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Pfizer Japan, sanofi-aventis and Schering-Plough. Makoto Uchiyama and Naohisa Uchimura have disclosed that they have accepted payment for consultancy work from Takeda Pharmaceutical. Makoto Uchiyama has disclosed accepting payment as a consultant from Astellas Pharma. Makoto Uchiyama has disclosed receipt of research funding from Eisai, Eli Lilly Japan, Janssen Pharmaceutical, Meiji Seika Kaisha, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Pfizer Japan, sanofi-aventis and Schering-Plough. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. Editorial assistance was provided by Content Ed Net and funding for this assistance was provided by Takeda Pharmaceutical Co., Ltd., Osaka, Japan.