Real-world evidence of the safety and efficacy profile of suvorexant in elderly patients with insomnia: a sub-analysis of the post-marketing drug-use results survey in Japan

Abstract

Objective: Global Phase III trials of suvorexant showed no obvious differences in the safety and efficacy profile of suvorexant between elderly and non-elderly patients. However, the clinical profile of suvorexant in elderly patients with comorbidities in a real-world setting was not evaluated. To further understand the safety and efficacy profile of suvorexant in elderly patients with insomnia in a daily clinical practice setting, we conducted a sub-group analysis of the post-marketing drug-use results survey.

Methods: Patients with insomnia who were treated with suvorexant for the first time were divided into three groups: group-1 (<65 years, N = 1490), group-2 (≥65 years and <75 years, N = 730), and group-3 (≥75 years, N = 1028).

Results: The incidence of overall adverse drug reactions (ADRs) were 11.28% (N = 168), 8.63% (N = 63), and 8.17% (N = 84) in group-1, -2, and -3, respectively. The ADRs most commonly observed in this survey were somnolence, insomnia, and dizziness, with no new safety concerns or differences in safety issues found. The numbers of patients in group-1, -2, and -3 who visited internal medicine departments were: 690 patients (46.3%), 521 patients (71.4%), and 793 patients (77.1%), respectively. The percentage of patients who were deemed to have “improved”, based on the patient’s self-assessment and their physician’s assessment, was 70–75% of patients in all groups.

Conclusion: These results reveal the safety and efficacy profile of suvorexant in elderly patients who often have various and multiple comorbidities and were treated in a daily clinical practice setting.

Keywords:

• Elderly
• insomnia
• post-marketing
• real-world
• safety
• suvorexant

Transparency

Declaration of funding

This study was sponsored by MSD K.K., Tokyo, Japan.

Declaration of financial/other relationships

All authors are employees of MSD K.K., Tokyo, Japan.

Acknowledgements

The authors thank all the doctors and staff of the medical institutions in Japan for providing us with the data. We also acknowledge Kathryn M. Connor and W. Joseph Herring (Merck & Co., Inc., Kenilworth, NJ, USA) and Shigeru Tokita and Shoki Okuda (MSD K.K., Tokyo, Japan) for their review and editorial input into this manuscript. We thank Editage (https://www.editage.jp) for English language editing.