PMID- 33526972
OWN - NLM
STAT- MEDLINE
DCOM- 20211011
LR  - 20211011
IS  - 1449-1907 (Electronic)
IS  - 1449-1907 (Linking)
VI  - 18
IP  - 5
DP  - 2021
TI  - Differences in detected safety signals between benzodiazepines and 
      non-benzodiazepine hypnotics: pharmacovigilance study using a spontaneous 
      reporting system.
PG  - 1130-1136
LID - 10.7150/ijms.51658 [doi]
AB  - Introduction: In recent years, there has been an increasing number of people who 
      feel sleep-deprived owing to sudden changes in the social environment. Patients 
      prescribed benzodiazepine-based hypnotics (BZ drugs) also develop movement 
      disorder action and memory disorders as adverse events (AEs), and they have 
      further problems such as dependency and tolerance because of long-term use. 
      Therefore, the use of non-benzodiazepine-based hypnotics (Z-drugs) is recommended 
      for patients with insomnia. However, as AEs have also been reported for Z-drugs, 
      it is important to identify these when switching hypnotics. Methods: To 
      understand AEs to be noted when switching from BZ drugs to Z-drugs, we evaluated 
      the differences in AEs developed by both these drugs using volcano plots and 
      safety signals. For this, data registered in the Japanese Adverse Drug Event 
      Report database were used. Results: The volcano plot and safety signals revealed 
      six characteristic Z-drug-induced AEs. Parasomnias (ln odds ratio [OR]: 3.28, 
      -log P: 4.34, proportional reporting ratio [PRR]: 23.47, chi (2): 309.27), Cortical 
      dysfunction NEC (ln OR: 2.76, -log P: 4.34, PRR: 3.62, chi (2): 16.14), and 
      Psychiatric symptoms NEC (ln OR: 2.66, -log P: 2.18, PRR: 2.51, chi (2): 6.63) were 
      detected only in Z-drugs, and safety signals of Suicidal and self-injurious 
      behaviour, Deliria, and Overdoses NEC were also detected with BZ drugs. However, 
      the strength of safety signals was much higher with the Z-drugs. Conclusion: AEs 
      related to falls and bone fractures are expected to be more strongly onset in BZ 
      drugs than in Z-drugs, which are said to have less muscle relaxant action. 
      However, there was no particularly significant difference in this parameter 
      between the two drug classes. Understanding the difference between these AEs of 
      Z-drugs and BZ drugs is important for the proper use of hypnotics.
CI  - (c) The author(s).
FAU - Toyoshima, Manabu
AU  - Toyoshima M
AD  - Department of Pharmacy, Kawasaki rinko general hospital; 3-13-1 Nakashima, 
      Kawasaki-ku, Kawasaki, 210-0806, Kanagawa, Japan.
FAU - Noguchi, Yoshihiro
AU  - Noguchi Y
AD  - Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University; 1-25-4, 
      Daigakunishi, Gifu, 501-1196, Gifu, Japan.
FAU - Otsubo, Manami
AU  - Otsubo M
AD  - Department of Pharmacy, Gifu University Hospital; 1-1, Yanagido, Gifu, 501-1194, 
      Gifu, Japan.
FAU - Tachi, Tomoya
AU  - Tachi T
AD  - Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University; 1-25-4, 
      Daigakunishi, Gifu, 501-1196, Gifu, Japan.
FAU - Teramachi, Hitomi
AU  - Teramachi H
AD  - Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University; 1-25-4, 
      Daigakunishi, Gifu, 501-1196, Gifu, Japan.
AD  - Laboratory of Community Healthcare Pharmacy, Gifu Pharmaceutical University; 
      1-25-4, Daigakunishi, Gifu, 501-1196, Gifu, Japan.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20210101
PL  - Australia
TA  - Int J Med Sci
JT  - International journal of medical sciences
JID - 101213954
RN  - 0 (Hypnotics and Sedatives)
RN  - 12794-10-4 (Benzodiazepines)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Benzodiazepines/*adverse effects
MH  - Drug Substitution
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/psychology
MH  - Humans
MH  - Hypnotics and Sedatives/*adverse effects
MH  - Japan/epidemiology
MH  - Pharmacovigilance
MH  - Sleep Initiation and Maintenance Disorders/*drug therapy
PMC - PMC7847624
OTO - NOTNLM
OT  - Japanese Adverse Drug Event Report database
OT  - benzodiazepine-based hypnotics
OT  - non-benzodiazepine-based hypnotics
OT  - signal detection
COIS- Competing Interests: The authors have declared that no competing interest exists.
EDAT- 2021/02/03 06:00
MHDA- 2021/10/12 06:00
PMCR- 2021/01/01
CRDT- 2021/02/02 06:10
PHST- 2020/08/07 00:00 [received]
PHST- 2020/12/19 00:00 [accepted]
PHST- 2021/02/02 06:10 [entrez]
PHST- 2021/02/03 06:00 [pubmed]
PHST- 2021/10/12 06:00 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - ijmsv18p1130 [pii]
AID - 10.7150/ijms.51658 [doi]
PST - epublish
SO  - Int J Med Sci. 2021 Jan 1;18(5):1130-1136. doi: 10.7150/ijms.51658. eCollection 
      2021.