[note: Kasper-authored] Objective: Silexan is a lavender oil preparation in gelatine capsules containing 80 mg [Silexan™ is an active substance manufactured by Dr. Willmar Schwabe GmbH & Co. KG]. We reviewed the clinical trials investigating the anxiolytic efficacy and tolerability of Silexan as well as its safety and potential for drug interactions.
Method: 7 trials were included, among which 4 therapeutic trials had a treatment duration of 6–10 weeks.
Results: In patients with subsyndromal anxiety or generalized anxiety disorder (GAD) an anxiolytic effect of Silexan was evident after 2 weeks. Patients treated with Silexan showed Hamilton Anxiety Scale (HAMA) total score decreases between 10.4 ± 7.1 and 12.0 ± 7.2 points at Week 6 and between 11.8 ± 7.7 and 16.0 ± 8.3 points at Week 10.
Conclusions: HAMA total score reductions between baseline and end of treatment were statistically-significantly superior to placebo in patients with subsyndromal anxiety and comparable to lorazepam in its starting dose in patients with GAD. Silexan had beneficial effects on typical co-morbidity symptoms of anxiety disorders, for example, disturbed sleep, somatic complaints, or decreased quality of life. Except for mild gastrointestinal symptoms, the drug was devoid of adverse effects and did not cause drug interactions or withdrawal symptoms at daily doses of 80 or 160 mg.
[Keywords: Silexan, lavender oil, anxiety disorder, review, clinical trials, efficacy]
…Statement of interest: Dr. Kasper has received grant/research support from Bristol Myers-Squibb, Eli Lilly, GlaxoSmithKline, Lundbeck, Organon, Sepracor and Servier; he has served as a consultant or on advisory boards for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Lundbeck, Merck Sharp and Dome (MSD), Novartis, Organon, Pfizer, Schwabe, Sepracor, and Servier; and he has served on speakers’ bureaus for Angelini, AstraZeneca, Bristol Myers-Squibb, Eli Lilly, Janssen, Lundbeck, Neuraxpharm, Pfizer, Pierre Fabre, Schwabe, Sepracor, and Servier.
