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.

journal_name

Curr Med Res Opin

authors

Takeuchi Y,Sano H,Asai Y,Miyazaki M,Iwakura M,Maeda Y

doi

10.1080/03007995.2019.1700361

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

465-471

issue

3

eissn

0300-7995

issn

1473-4877

journal_volume

36

pub_type

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