Analyses of non-benzodiazepine-induced adverse events and prognosis in elderly patients based on the Japanese adverse drug event report database

Yoshihiro Noguchi,Tomoya Tachi,Hayato Katsuno,Manami Otsubo,Teruo Tsuchiya,Ikuto Sugita,Aki Yoshida,Hitomi Teramachi,Yuta Kanematsu,Anri Ueno

doi:10.1186/s40780-018-0106-2

Abstract

BackgroundThe contents of the guidelines for the use of non-benzodiazepines (Z-drugs) differ slightly between THE JAPANESE SOCIETY OF SLEEP RESEARCH and THE JAPAN GERIATRIC SOCIETY, and the recommended directions are conflicting. Therefore, we analyzed the use of the Japanese Adverse Drug Event Report database (JADER) for identifying adverse events (AEs) caused by Z-drugs and clarifying their occurrence trend and prognosis.MethodsThe signal value for comparison was calculated by using the proportional reporting ratio (PRR) and chi-squared test (χ2) results of data of elderly and non-elderly patients. Among AEs for which signals were detected in the elderly, we determined that those with lower signal values for non-elderly patients that were half the signal value of the elderly should be used with particular caution in the elderly. We also compared the prognoses.ResultsThe AEs with > 1 risk ratio (RR) in elderly and non-elderly patients were regarded as those that should be noted in the prognosis of AEs in elderly patients. Furthermore, 28 AEs were detected in elderly patients’ signals. In this study, in addition to movement disorders such as “falls” and “bone fractures,” identified by two academic societies, signal characteristics of the elderly were obtained for psychiatric disorders and eye disorders.ConclusionsThere was no difference in prognosis, but these disorders could reduce the quality of life of patients. Therefore, we consider that in prescribing appropriate drug therapy for insomnia, attention should be paid to the occurrence of the AEs caused by the Z-drugs revealed by this study and the guidelines.

Highlights

The contents of the guidelines for the use of non-benzodiazepines (Z-drugs) differ slightly between THE JAPANESE SOCIETY OF SLEEP RESEARCH and THE JAPAN GERIATRIC SOCIETY, and the recommended directions are conflicting
The “ Clinical guidelines for proper use of sleeping pills and drug withdrawal” of THE JAPANESE SOCIETY OF SLEEP RESEARCH states that the quality of evidence is “moderate” and the recommendation is “weak,” and it recommends the use of Z-drugs for elderly people who experience sleeplessness [3]
In this study, in addition to movement disorders such as “falls” and “bone fractures” recorded by “THE JAPANESE SOCIETY OF SLEEP RESEARCH” and “THE JAPAN GERIATRIC SOCIETY,” signals that are characteristic to the elderly were obtained for psychiatric disorders and eye disorders

Summary

Introduction

The contents of the guidelines for the use of non-benzodiazepines (Z-drugs) differ slightly between THE JAPANESE SOCIETY OF SLEEP RESEARCH and THE JAPAN GERIATRIC SOCIETY, and the recommended directions are conflicting. The “ Clinical guidelines for proper use of sleeping pills and drug withdrawal” of THE JAPANESE SOCIETY OF SLEEP RESEARCH states that the quality of evidence is “moderate” and the recommendation is “weak,” and it recommends the use of Z-drugs for elderly people who experience sleeplessness [3]. The “Guidelines for Medical Treatment and its Safety in the Elderly 2015” of THE JAPAN GERIATRIC SOCIETY indicate that the quality of the evidence is “moderate” and the recommendation degree is “strong.” long-term use of Z-drug among the elderly is not recommended [3]

Methods

Results

Conclusion