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Safety analysis of zolpidem in elderly subjects 80 years of age or older: adverse event monitoring in Japanese subjects.

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Title: Safety analysis of zolpidem in elderly subjects 80 years of age or older: adverse event monitoring in Japanese subjects.
Authors: Kajiwara, Ayami (AUTHOR), Yamamura, Masato (AUTHOR), Murase, Motoji (AUTHOR), Koda, Haruo (AUTHOR), Hirota, Seisuke (AUTHOR), Ishizuka, Tadao (AUTHOR), Morita, Kazunori (AUTHOR), Oniki, Kentaro (AUTHOR), Saruwatari, Junji (AUTHOR), Nakagawa, Kazuko (AUTHOR)
Source: Aging & Mental Health. Jun2016, Vol. 20 Issue 6, p611-615. 5p. 1 Chart.
Subjects: Drug side effects, Fisher exact test, Longitudinal method, Probability theory, Research funding, Sex distribution, Sleep disorders, T-test (Statistics), Mathematical variables, Zolpidem, Multiple regression analysis, Data analysis software, Descriptive statistics, Odds ratio, Old age
Geographic Terms: Japan
Abstract: Objectives: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). Conclusion: 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. [ABSTRACT FROM AUTHOR]
Copyright of Aging & Mental Health is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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DbLabel: Psychology and Behavioral Sciences Collection
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PubType: Academic Journal
PubTypeId: academicJournal
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  Data: Safety analysis of zolpidem in elderly subjects 80 years of age or older: adverse event monitoring in Japanese subjects.
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  Data: <searchLink fieldCode="AR" term="%22Kajiwara%2C+Ayami%22">Kajiwara, Ayami</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yamamura%2C+Masato%22">Yamamura, Masato</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Murase%2C+Motoji%22">Murase, Motoji</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Koda%2C+Haruo%22">Koda, Haruo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hirota%2C+Seisuke%22">Hirota, Seisuke</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ishizuka%2C+Tadao%22">Ishizuka, Tadao</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Morita%2C+Kazunori%22">Morita, Kazunori</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Oniki%2C+Kentaro%22">Oniki, Kentaro</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Saruwatari%2C+Junji%22">Saruwatari, Junji</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nakagawa%2C+Kazuko%22">Nakagawa, Kazuko</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Aging+%26+Mental+Health%22">Aging & Mental Health</searchLink>. Jun2016, Vol. 20 Issue 6, p611-615. 5p. 1 Chart.
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  Data: <searchLink fieldCode="DE" term="%22Drug+side+effects%22">Drug side effects</searchLink><br /><searchLink fieldCode="DE" term="%22Fisher+exact+test%22">Fisher exact test</searchLink><br /><searchLink fieldCode="DE" term="%22Longitudinal+method%22">Longitudinal method</searchLink><br /><searchLink fieldCode="DE" term="%22Probability+theory%22">Probability theory</searchLink><br /><searchLink fieldCode="DE" term="%22Research+funding%22">Research funding</searchLink><br /><searchLink fieldCode="DE" term="%22Sex+distribution%22">Sex distribution</searchLink><br /><searchLink fieldCode="DE" term="%22Sleep+disorders%22">Sleep disorders</searchLink><br /><searchLink fieldCode="DE" term="%22T-test+%28Statistics%29%22">T-test (Statistics)</searchLink><br /><searchLink fieldCode="DE" term="%22Mathematical+variables%22">Mathematical variables</searchLink><br /><searchLink fieldCode="DE" term="%22Zolpidem%22">Zolpidem</searchLink><br /><searchLink fieldCode="DE" term="%22Multiple+regression+analysis%22">Multiple regression analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Data+analysis+software%22">Data analysis software</searchLink><br /><searchLink fieldCode="DE" term="%22Descriptive+statistics%22">Descriptive statistics</searchLink><br /><searchLink fieldCode="DE" term="%22Odds+ratio%22">Odds ratio</searchLink><br /><searchLink fieldCode="DE" term="%22Old+age%22">Old age</searchLink>
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  Label: Geographic Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Japan%22">Japan</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Objectives: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). Conclusion: 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Aging & Mental Health is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1080/13607863.2015.1031640
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      – Code: eng
        Text: English
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        PageCount: 5
        StartPage: 611
    Subjects:
      – SubjectFull: Drug side effects
        Type: general
      – SubjectFull: Fisher exact test
        Type: general
      – SubjectFull: Longitudinal method
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      – SubjectFull: Probability theory
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      – SubjectFull: Research funding
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      – SubjectFull: Sex distribution
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      – SubjectFull: Sleep disorders
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      – SubjectFull: T-test (Statistics)
        Type: general
      – SubjectFull: Mathematical variables
        Type: general
      – SubjectFull: Zolpidem
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      – SubjectFull: Multiple regression analysis
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      – SubjectFull: Data analysis software
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      – SubjectFull: Odds ratio
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      – SubjectFull: Old age
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      – SubjectFull: Japan
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      – TitleFull: Safety analysis of zolpidem in elderly subjects 80 years of age or older: adverse event monitoring in Japanese subjects.
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              Text: Jun2016
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