Abstract

The aim of the present study was to analyze the association between the prescription of Silexan and the recurrence of general practitioner (GP) repeat consultations because of disturbed sleep versus benzodiazepine receptor agonists including zolpidem, zopiclone, and zaleplon (Z-drugs). This retrospective cohort study was based on data from the IQVIA Disease Analyzer (DA) database. The study included adult patients treated by 1284 GPs in Germany with a documented sleep disorder and their first prescription of Silexan or Z-drug (prescription between January 2010 and October 2020). The recurrence of seeking medical advice because of sleep disorders in the 15-365 days after the first prescription was evaluated. Multivariate regression models were used, adjusted for age, sex, insurance status, and defined co-diagnoses. Data were available for 95,320 (Silexan: 5204; Z-Drug: 90,526) patients. In total, 15.6% of the Silexan patients and 28.6% of the Z-drug patients had a further documented GP consultation because of a sleep disorder. Silexan prescription was associated with significantly lower odds of recurrent sleep disorder diagnosis in the 15-365 days after the index date (Odds Ratio (OR): 0.56; 95% confidence intervals (CI): 0.51-0.60), although mental burden levels appeared higher in this group. Our study shows that the prescription of Silexan to adult patients consulting GPs for disturbed sleep results in less frequent repeat consultations than Z-drugs. This may support Silexan's role as an efficacious, self-enabling, well-tolerated, and sustained treatment option. Because Silexan is a proven anxiolytic, its impact in improving undiagnosed anxiety disorders may have had a lasting effect for certain patients.

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