Sandra is a 47 year old woman with a past medical history of an abnormal pap smear. She has generalized anxiety disorder (GAD) and is in weekly psychotherapy. Since her mother was diagnosed with breast cancer 2 months ago, Sandra’s anxiety has worsened. She now has daily episodes of agitation and restlessness, especially when thinking about her mom, and trouble falling asleep. Her GAD-7 score is 16.
For the first time in your 10 year relationship, Sandra asks about medication options for anxiety. She feels she needs medication for anxiety but also worries about potential side effects, specifically weight gain and sedation. You mention that many medication options for anxiety can cause weight gain and/or sedation, including SSRI/SNRIs, gabapentinoids, mirtazapine, hydroxyzine and benzodiazepines. Given her preferences, you suggest a slow titration of buspirone.
Sandra decides not to start medication – this conversation is causing her too much anxiety. “Isn’t there something natural that can help my anxiety?”
You offer the possibility of Silexan, a branded extract of lavender that is available over the counter.
How do you use Silexan for anxiety disorders?
Does Silexan treat anxiety?
Oral lavender has been shown to help generalized anxiety disorder, mixed anxiety and depression disorder, subthreshold anxiety disorder, and anxiety related restlessness and sleep disturbance.
Kasper et al. conducted multiple randomized controlled trials that support the efficacy and tolerability of lavender in capsule form (Kasper 2014, 2015, 2016). A randomized, double-blind, double-dummy, multi-clinic trial with 4 parallel groups (n=~130 participants per group, Silexan 160 mg, Silexan 80 mg, paroxetine 20 mg, and placebo) looked at the reduction in anxiety on the Hamilton Anxiety Scale in people with GAD. Both doses of Silexan were superior to placebo in treating anxiety; Silexan 160 mg was more effective than 80 mg. Comparing Silexan and paroxetine, positive mean differences favored the efficacy of Silexan 80mg and 160mg over paroxetine 20mg, but these differences did not achieve statistical significance (Kasper 2014).
The same research group found Silexan 80 mg to be superior to placebo for anxiety-related diagnoses (agitation and restlessness, mixed anxiety-depression) (Kasper 2015, 2016). A smaller (n=~40 participants per treatment group) double-blind randomized trial looked at Silexan 80 mg daily vs lorazepam 0.5 mg daily in patients with GAD. Silexan 80 mg was shown to be non-inferior to lorazepam 0.5 mg (Woelk 2009). While the studies from Kasper and Woelk are high quality and consistently positive, they were performed by researchers at a single academic center and were funded by the drug manufacturer (Dr. Willmar Schwabe GmbH & Co. KG).
Inhaled lavender also reduces anxiety. A 2023 systematic review found that inhaled lavender reduced anxiety in anxiety-inducing situations (pre-operative setting, IUD placement, others) in both non-anxious adults and in adults with GAD (Yoo 2023).
I recommend lavender as initial therapy for GAD only for patients who do not want to take first-line medications for GAD, or who have mild or subsyndromal anxiety symptoms that would not warrant treatment with an SSRI. Some patients who are unable to tolerate multiple first-line medications for anxiety may also benefit from Silexan. More randomized controlled trials in more diverse patient populations are warranted before lavender is promoted as a first line treatment option for GAD.
Dosing & Titration
Silexan is sold in the US as CalmAid from Nature’s Way. It is available over the counter in 80 mg soft gels. Start Silexan 80 mg at bedtime. Patients may notice an effect on their anxiety within 2 weeks but a separation from placebo may not occur until 6 weeks (Kasper 2014). If symptoms are not significantly improved after 6 weeks, Silexan may be titrated to 160 mg daily.
Side effects
Silexan does not have any known drug-drug interactions or major side effects. The most commonly reported side effect is lavender flavored burps. There is no risk of weight gain, sedation, or sexual side effects. Silexan can be stopped abruptly without a taper.
We don’t recommend using Silexan in children. There are case reports of prepubertal gynecomastia in young boys and premature thelarche in young girls exposed to transdermal lavender and tea tree oils that resolved with cessation of use (Henley 2007, Ramsey 2019), suggesting that lavender oil mimics estrogen and/or exerts an anti-androgen effect. Some clinicians also suggest avoiding lavender products in patients with breast cancer. We have no data in this population and recommend collaborating with your patient’s oncologist if you are considering Silexan.
Returning to Sandra
Sandra buys Silexan over the counter for $18 for 1 month. She has no side effects. By 8 weeks, Sandra’s anxiety is better with a GAD-7 score 6.
Key Points
- Silexan, an OTC oral medication made of lavender extract is well tolerated and effective in treating GAD and subsyndromal anxiety. In studies, Silexan 160mg was slightly more effective than 80mg.
- It may take 6 weeks to get the full anxiolytic benefit of Silexan at a given dose.
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References:
Kasper, S., Anghelescu, I., & Dienel, A. (2015). Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial. European Neuropsychopharmacology, 25(11), 1960–1967. https://doi.org/10.1016/j.euroneuro.2015.07.024
Kasper, S., Gastpar, M., Müller, W. E., Volz, H.-P., Möller, H.-J., Schläfke, S., & Dienel, A. (2014). Lavender oil preparation Silexan is effective in generalized anxiety disorder – a randomized, double-blind comparison to placebo and paroxetine. The International Journal of Neuropsychopharmacology, 17(06), 859–869. https://doi.org/10.1017/S1461145714000017
Kasper, S., Volz, H.-P., Dienel, A., & Schläfke, S. (2016). Efficacy of Silexan in mixed anxiety–depression – A randomized, placebo-controlled trial. European Neuropsychopharmacology, 26(2), 331–340. https://doi.org/10.1016/j.euroneuro.2015.12.002
Henley, Derek V., et al. (2007). Prepubertal gynecomastia linked to lavender and tea tree oils. New England Journal of Medicine 356(5), 479-485.
Ramsey, J. T., Li, Y., Arao, Y., Naidu, A., Coons, L. A., Diaz, A., & Korach, K. S. (2019). Lavender Products Associated With Premature Thelarche and Prepubertal Gynecomastia: Case Reports and Endocrine-Disrupting Chemical Activities. The Journal of Clinical Endocrinology & Metabolism, 104(11), 5393–5405. https://doi.org/10.1210/jc.2018-01880
Woelk, H., & Schläfke, S. (2010). A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine, 17(2), 94–99. https://doi.org/10.1016/j.phymed.2009.10.006
Yoo, O., & Park, S.-A. (2023). Anxiety-Reducing Effects of Lavender Essential Oil Inhalation: A Systematic Review. Healthcare, 11(22), 2978. https://doi.org/10.3390/healthcare11222978