Residual effects of suvorexant, zolpidem and ramelteon in healthy elderly subjects: a randomized double-blind study

2019 Fiscal Year Final Research Report

• Project/Area Number: 16K01496
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Rehabilitation science/Welfare engineering
• Research Institution: Akita University
• Principal Investigator: Ito Uemura Sachiko (上村佐知子) 秋田大学, 医学系研究科, 准教授 (40271829)
• Co-Investigator(Kenkyū-buntansha): 神林 崇 秋田大学, 医学系研究科, 准教授 (50323150)
• Project Period (FY): 2016-04-01 – 2020-03-31
• Keywords: スボレキサント / ラメルテオン / ゾルピデム / 残余効果 / 運動機能 / 精神機能

Outline of Final Research Achievements

The purpose of the present study was to evaluate the residual effects of the new agent in elderly subjects. 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 and subjective ratings were obtained every 2 hours from 4:00 to 16:00. During our study, no subjects showed serious side effects from physical observations and vital sign checks done before and after hypnotics were taken. None of the three drugs was significantly inferior to placebo in all parameters.There was a significant difference among three drugs and placebo in REM sleep time, and suvorexant was significantly longer than zolpidem. For the body sway test with closed eye, we found the main effects of the medicines and zolpidem was significantly better than suvorexant and ramelteon.

Free Research Field

リハビリテーション科学

Academic Significance and Societal Importance of the Research Achievements

高齢者の転倒理由として睡眠導入剤の使用も数多く指摘されている。しかし、実際の高齢者の睡眠導入剤服薬後の運動機能や認知機能を検査した研究は数少ない。GAGA作動薬であるBZ系睡眠導入剤は筋弛緩作用などを持つことから、最近ではオレキシン拮抗薬のスボレキサントやしばらく前にはメラトニン作動薬のラメルテオンが導入されている。ラメルテオンやスボレキサントは、筋弛緩作用がほとんどなく、中途覚醒時に筋の弛緩による転倒のリスクが少ないと考えられている。このように、転倒の恐れが少ない安全な睡眠導入剤を、高齢者の日常生活を踏まえて検討する取り組みは重要であり、有意義であると考えている。