Silexan is well-tolerated for long-term use in adults and for treatment of adolescents: a real-world data analysis.

Abstract

For Silexan, a proprietary preparation of Lavandula angustifolia flowers, efficacy and tolerability in adults with anxiety disorders was demonstrated in clinical trials lasting up to 10 weeks. The present study investigated the extent and tolerability of long-term and adolescent use in real world. For the retrospective analysis of patients with a first prescription for Silexan, case-based information provided by office-based physicians from Germany was extracted from the IQVIA Disease Analyzer (DA) database. Patients treated by general practitioners and specialists were analysed. Proportions of patients with long-term therapy (> 3 months, > 6 months) and adolescent patients (aged 12-17 years) were determined, incidence rates of diagnoses or complaints compatible with known adverse effects before and after therapy initiation were estimated. Long-term usage was additionally analysed by data from the Swiss longitudinal prescription (LRx) database, which covers approximately 50% of pharmacies and most physicians of Switzerland. 67,340 adults (DA 36,664, LRx 30,676) with at least one Silexan prescription were analysed. Of these, 4.0% (DA) and 27.6% (LRx) had more than 3 months of therapy. DA data included 483 (1.3%) adolescent patients. Diagnoses or complaints compatible with known adverse effects were rare among long-term or adolescent Silexan users and did not differ significantly during the period of Silexan therapy compared to an equivalent period before Silexan therapy. Our findings suggest that Silexan is a frequently used and well-tolerated treatment option for individuals requiring extended relief from their symptoms. It might provide a well-tolerated pharmacologic treatment option for adolescents.