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Association between the Use of Suvorexant and Hip Fracture in Older Adults in Japan Using a Nationwide Administrative Claims Database: A Matched Case–Control Study

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Abstract

Background and Objective

The use of benzodiazepines and nonbenzodiazepines increases the risk for hip fracture, but the effect of suvorexant, an orexin receptor antagonist, is not clear. The objective of this study was to investigate the association between suvorexant use and hip fractures in older adults.

Methods

A case–control study was conducted using real-world data (RWD) from Medical Data Vision Co., Ltd. with patients hospitalized between January 2019 and December 2020. Patients were aged 65–84 years and had been prescribed suvorexant at least once. Patients with hip fracture (cases) and those without (controls) were identified by matching up to 1:4 for sex, age (± 2 years), and hospital size category. Suvorexant exposure was identified the day before hospitalization. Hip fracture risk associated with suvorexant was presented as adjusted odds ratios (aOR) with 95% confidence intervals (CI) using conditional logistic regression analysis.

Results

Matching identified 389 cases and 1509 controls. The risk of hip fracture was not increased in patients treated with suvorexant [aOR: 0.86, 95% confidence interval (CI) 0.61–1.20]. Additionally, concomitant use of suvorexant with other hypnotics did not increase the risk. Benzodiazepines (1.01, 0.46–2.22), nonbenzodiazepines (1.16, 0.57–2.34), and melatonin (1.80, 0.82–3.94) were combined with suvorexant. The risk was increased for the use of benzodiazepine without suvorexant (1.88, 1.10–3.21).

Conclusions

Using RWD in Japanese older adults, we showed that sleep therapy with suvorexant was not associated with an increased risk of hip fracture. The results provide evidence-based drug safety information for the selection of hypnotics for sleep disorders, which increase with age.

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Authors and Affiliations

  1. Medical Technology Innovation Center, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan

    Tomoyuki Saito & Shuko Nojiri

  2. Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan

    Takatoshi Kasai & Hiroyuki Daida

  3. Department of Ophthalmology, Juntendo University School of Medicine, Tokyo, Japan

    Yoshimune Hiratsuka

  4. Department of Medicine for Orthopaedics and Motor Organ, Juntendo University Graduate School of Medicine, Tokyo, Japan

    Muneaki Ishijima

Authors
  1. Tomoyuki Saito
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  3. Takatoshi Kasai
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  4. Yoshimune Hiratsuka
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Corresponding author

Correspondence to Shuko Nojiri.

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Funding

This work was supported by JSPS KAKENHI grant number JP19K12870. The funding agency has no role other than funding this study, and the results reported here are independent of the funding source.

Conflicts of interest

All authors declare that they have no conflicts of interest.

Ethical approval

This study protocol was approved by the ethics committee of Juntendo University (approval number: E21-0264). According to the Ethical Guidelines for Medical and Biological Research Involving Human Subjects, informed consent is not necessarily required for the use of nonpersonally identifiable data (https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hokabunya/kenkyujigyou/i-kenkyu/index.html). Therefore, this study was exempt from the requirement for written informed consent.

Consent to participate

Not applicable.

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Not applicable.

Availability of data and materials

The original data used for this survey were purchased from a medical information database handling company and, therefore, could not be shared. The analysis datasets of this study are available from the corresponding author upon reasonable request.

Code availability

Not applicable.

Authors' contribution

Study design (TS, SN), data collection and data analysis (TS, SN), interpretation of results (TS, SN, TK, YH), drafting of the manuscript (TS, SN, TK, YH, MI, HD), revision of the manuscript (TS, SN, TK, YH, MI, HD). All authors read and approved the final submitted manuscript and agree to be accountable for the work.

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Saito, T., Nojiri, S., Kasai, T. et al. Association between the Use of Suvorexant and Hip Fracture in Older Adults in Japan Using a Nationwide Administrative Claims Database: A Matched Case–Control Study. Drugs Aging 40, 439–447 (2023). https://doi.org/10.1007/s40266-023-01033-5

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