0348 RESIDUAL EFFECTS OF SUVOREXANT, ZOLPIDEM AND RAMELTEON IN HEALTHY ELDERLY SUBJECTS: A RANDOMIZED DOUBLE-BLIND STUDY

• Published in: Sleep Vol. 40; no. suppl_1; p. A130
• Main Authors: Ito, SU, Kanbayashi, T, Ito, A, Kimoto, Y, Ono, T, Satake, M, Shioya, T, Shimizu, T, Nishino, S
• Format: Journal Article
• Language: English; Japanese
• Published: US Oxford University Press (OUP) 28.04.2017; Oxford University Press
• Subjects: Double-blind studies; Older people
• ISSN: 0161-8105; 1550-9109
• DOI: 10.1093/sleepj/zsx050.347

Abstract Introduction: Next-day residual effects are a common problem with current hypnotic agents. The purpose of the present study was to evaluate the residual effects of the new agent - suvorexant that doesn’t have the muscle relaxation effect - on the physical and cognitive functions of healthy elderly people in the early morning and the day following drug administration. In this study, the next-day residual effects of suvorexant, zolpidem and ramelteon following bedtime dosing in elderly subjects were evaluated. Methods: Six men and eight women aged 63–75 years received a single tablet (at 23:00), suvorexant 10 mg, zolpidem 5mg, ramelteon 4mg or placebo in a randomized, double-blind and crossover design. Measures of objective parameters (Timed up and Go test, Functional Reach Test, body sway test, critical flicker fusion test, simple discrimination reaction test and short-term memory test) and subjective ratings were obtained every 2 hour from 4:00 to 16:00. Akita University Ethics Committee approved the protocol. Written informed consent was obtained from all subjects. Results: During our study, no subjects showed serious side effects, since physical observations and vital sign checks were done before and after hypnotics were taken. Furthermore, safety management was ensured such as by having a standby physician at all times. For the body sway test (closed eye), we find the main effects of the drug (p=0.012) with R-ANOVA and zolpidem was significant better than suvorexant and ramelteon in a multiple comparison using Bonferroni. The other parameters showed no significant differences. Conclusion: Based on the above results, the changes of physical and cognitive functions in healthy elderly after taking hypnotics, it would be recognized that hypnotics are likely to be suitable for the elderly people with insomnia. Support (If Any): This study was funded by Grants-and-Aid for Scientific Research ‘Scientific Research (C) (General)’ (16K01496).