title: Safety analysis of zolpidem in elderly subjects 80 years of age or older: adverse event monitoring in Japanese subjects.
abstract: OBJECTIVE
  Prescriptions of non-benzodiazepine sedative hypnotics, e.g. zolpidem, for insomnia in elderly subjects 80 years of age or older have markedly increased in the USA. However, a meta-analysis of the risks and benefits of hypnotics in older people reported the benefits associated with hypnotics use are outweighed by the risks. This study aimed to investigate the safety of zolpidem administration in extremely old elderly.
  
  
  METHODS
  The prevalence of adverse reactions to zolpidem was investigated in a subpopulation of participants in the Drug Event Monitoring project of the Japan Pharmaceutical Association. A total of 1011 (316 males and 695 females) zolpidem users, including 261 (25.8%) subjects 80 years of age or older without cognitive or mental complications, were eligible for the analysis.
  
  
  RESULTS
  The elderly and female patients were prescribed significantly lower doses of zolpidem than their counterparts. Adverse symptoms after the last prescription were reported by 60 (5.9%) subjects. The most common symptoms were impaired balance and/or falls (1.8%) and morning drowsiness (1.3%). The multiple logistic regression analyses showed that subjects 80 years of age or older were at lower risk of adverse symptoms (odds ratio 0.39, 95% confidence intervals: 0.17-0.88).
  
  
  CONCLUSIONS
  Our findings in a real-world clinical setting suggest that low-dose zolpidem can be safely prescribed to subjects 80 years of age or older without cognitive or mental complications.
authors: a Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.
authors: Ayami
authors: A
authors: Kajiwara
authors: b Kumamoto Pharmaceutical Association , Kumamoto , Japan.
authors: Masato
authors: M
authors: Yamamura
authors: b Kumamoto Pharmaceutical Association , Kumamoto , Japan.
authors: Motoji
authors: M
authors: Murase
authors: b Kumamoto Pharmaceutical Association , Kumamoto , Japan.
authors: Haruo
authors: H
authors: Koda
authors: b Kumamoto Pharmaceutical Association , Kumamoto , Japan.
authors: Seisuke
authors: S
authors: Hirota
authors: c Division of Pharmaceutical Molecular Design, Graduate School of Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.|d Center for Clinical Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.
authors: Tadao
authors: T
authors: Ishizuka
authors: a Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.
authors: Kazunori
authors: K
authors: Morita
authors: a Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.
authors: Kentaro
authors: K
authors: Oniki
authors: a Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.
authors: Junji
authors: J
authors: Saruwatari
authors: a Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.|d Center for Clinical Pharmaceutical Sciences , Kumamoto University , Kumamoto , Japan.
authors: Kazuko
authors: K
authors: Nakagawa
mesh_terms: D000369:Aged, 80 and over; D000375:Aging / Q000187:drug effects*; D016903:Drug Monitoring / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects*; D007564:Japan / Q000453:epidemiology; D008297:Male; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects*; D000077334:Zolpidem
chemical_list: D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem
keywords: adverse event monitoring; older people; self-report; sleep disorders; zolpidem