Lavendelolja Schwabe (Silexan): Uses, Dosage & Side Effects
Standardized lavender oil soft capsules for the relief of anxiety and restlessness
Lavendelolja Schwabe contains Silexan, a standardized preparation of lavender oil (Lavandula angustifolia) available as 80 mg soft capsules. It is a prescription herbal anxiolytic used to relieve symptoms of anxiety, restlessness, and nervous tension in adults. Unlike benzodiazepines, Silexan does not cause sedation, cognitive impairment, or dependence. Clinical trials have demonstrated its efficacy comparable to lorazepam and paroxetine for generalized anxiety disorder.
Quick Facts
Key Takeaways
- Lavendelolja Schwabe (Silexan) is a prescription herbal anxiolytic containing 80 mg standardized lavender oil per soft capsule, used for anxiety and restlessness in adults.
- Clinical trials show comparable efficacy to lorazepam (0.5 mg) and paroxetine (20 mg) for generalized anxiety disorder, with significantly fewer side effects.
- The mechanism of action involves modulation of voltage-dependent calcium channels rather than GABA receptors, meaning no sedation, no cognitive impairment, and no dependence potential.
- The most common side effects are gastrointestinal (lavender-flavored burping, nausea), which are generally mild and transient.
- Not recommended during pregnancy or breastfeeding due to insufficient safety data. Should not be used in children under 18 years of age.
What Is Lavendelolja Schwabe and What Is It Used For?
Lavendelolja Schwabe contains Silexan, a proprietary preparation of essential oil derived from Lavandula angustifolia (narrow-leaved lavender). The oil is produced through steam distillation of the flowering tops of the plant and is standardized to contain specific quantities of the key active constituents, primarily linalool and linalyl acetate. The pharmaceutical-grade preparation ensures batch-to-batch consistency, which is essential for reliable therapeutic effects.
The product was developed by Dr. Willmar Schwabe GmbH & Co. KG, a German pharmaceutical company with a long tradition in phytopharmaceutical research. Silexan has been the subject of numerous clinical trials since the early 2000s, and the body of evidence supporting its anxiolytic properties has grown substantially. The European Medicines Agency (EMA) Committee on Herbal Medicinal Products (HMPC) has evaluated the clinical evidence for lavender oil preparations and has acknowledged the established use of these preparations for the relief of mild symptoms of mental stress and to aid sleep.
Lavendelolja Schwabe is primarily indicated for the symptomatic relief of anxiety and restlessness. Clinical trials have demonstrated its efficacy in patients with generalized anxiety disorder (GAD), subsyndromal anxiety (anxiety symptoms that do not fully meet the diagnostic criteria for an anxiety disorder), and mixed anxiety and depressive disorder. The anxiolytic effects typically become apparent within the first two weeks of treatment, with continued improvement over the course of therapy lasting six to ten weeks in most clinical studies.
Pharmacological Classification
Silexan is classified as a herbal anxiolytic. It differs fundamentally from conventional anxiolytic medications in its pharmacological profile. While benzodiazepines (such as diazepam, lorazepam, and alprazolam) exert their anxiolytic effects by enhancing gamma-aminobutyric acid (GABA) transmission at GABA-A receptors, Silexan operates through an entirely different mechanism. The primary mode of action involves the modulation of voltage-dependent calcium channels (VOCCs), specifically the N-type and P/Q-type channels, in the central nervous system.
By inhibiting calcium influx through these channels, Silexan reduces neuronal hyperexcitability in limbic and cortical brain regions that are implicated in anxiety processing. Additionally, Silexan has been shown to inhibit the serotonin transporter (SERT), which may contribute to its anxiolytic and mood-improving properties. Importantly, because Silexan does not interact with GABA-A receptors, it does not cause the sedation, psychomotor impairment, or dependence that characterize benzodiazepine therapy.
This favorable pharmacological profile makes Lavendelolja Schwabe a particularly attractive option for patients who require anxiolytic treatment but wish to avoid the risks associated with conventional medications, including those who operate machinery or drive vehicles, and those with a history of substance use disorders where dependence-forming medications would be contraindicated.
What Should You Know Before Taking Lavendelolja Schwabe?
Contraindications
Lavendelolja Schwabe should not be used by individuals who have a known hypersensitivity (allergy) to lavender oil, other Lavandula species, or any of the excipient ingredients in the soft capsule formulation. Allergic reactions to lavender are uncommon but can include contact dermatitis, urticaria (hives), or in very rare cases, more severe hypersensitivity reactions. Individuals with a documented history of allergic reactions to essential oils or members of the Lamiaceae (mint) plant family should exercise particular caution.
There is currently insufficient clinical data to support the use of Lavendelolja Schwabe in children and adolescents under 18 years of age. The pivotal clinical trials that established the efficacy and safety profile of Silexan were conducted exclusively in adult populations. Therefore, the product is not recommended for pediatric use until further research clarifies the safety and appropriate dosing in younger age groups.
Patients with severe hepatic impairment (liver disease) should use Lavendelolja Schwabe with caution, as the metabolism of terpene compounds, including linalool and linalyl acetate, may be altered in the presence of significant liver dysfunction. Although no specific dose adjustment recommendations exist for hepatic impairment, medical supervision is advisable in these patients.
Warnings and Precautions
While Lavendelolja Schwabe is generally well tolerated, certain precautions should be observed. Patients experiencing persistent or worsening anxiety symptoms despite treatment should consult their healthcare provider, as these symptoms may indicate an underlying condition requiring different therapeutic intervention. Lavendelolja Schwabe is intended for the relief of mild to moderate anxiety symptoms and should not be considered a substitute for comprehensive psychiatric evaluation and management in cases of severe anxiety or panic disorder.
If you experience signs of a severe allergic reaction such as difficulty breathing, swelling of the face, lips, tongue, or throat, or severe skin rash, stop taking Lavendelolja Schwabe immediately and seek emergency medical attention. Although severe allergic reactions are extremely rare, they require immediate treatment.
The soft capsules contain gelatin and may contain traces of soy lecithin or other excipients. Patients with known allergies to soy, gelatin, or other capsule components should review the full list of ingredients with their pharmacist before starting treatment. Individuals with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also check the excipient list, as some formulations may contain these sugars.
Pregnancy and Breastfeeding
The safety of Lavendelolja Schwabe during pregnancy has not been established through adequate clinical studies. Animal reproductive toxicity studies with Silexan are limited, and there is insufficient data to assess the potential risk to the developing fetus. As a precautionary measure, the use of Lavendelolja Schwabe during pregnancy is not recommended unless a qualified healthcare provider determines that the expected benefit to the mother clearly outweighs the potential risk to the fetus.
It is not known whether Silexan or its metabolites are excreted in human breast milk. Given the lipophilic nature of essential oil components, passage into breast milk cannot be excluded. Therefore, the use of Lavendelolja Schwabe during breastfeeding is not recommended. Women who are breastfeeding should consult their healthcare provider for alternative approaches to managing anxiety symptoms, which may include cognitive behavioral therapy (CBT) or other non-pharmacological interventions.
Women of childbearing potential should discuss contraception and pregnancy planning with their healthcare provider before initiating treatment with Lavendelolja Schwabe, particularly if pregnancy is planned or suspected.
How Does Lavendelolja Schwabe Interact with Other Drugs?
The drug interaction profile of Silexan has been investigated in several pharmacokinetic studies. Compared to many conventional anxiolytics, Silexan demonstrates a relatively favorable interaction profile. However, as with any medication, potential interactions should be considered and discussed with a healthcare provider before initiating treatment.
In vitro studies have shown that linalool, the primary constituent of Silexan, can inhibit certain cytochrome P450 (CYP) enzyme isoforms at high concentrations. The clinical significance of this finding at the therapeutic dose of 80 mg daily is considered to be low. Nevertheless, monitoring is advisable when Silexan is co-administered with drugs that have a narrow therapeutic index and are primarily metabolized by CYP3A4 or CYP2D6.
| Drug / Drug Class | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Warfarin / Anticoagulants | Theoretical increased bleeding risk | Moderate | Monitor INR closely; inform prescriber |
| Benzodiazepines (e.g., diazepam, lorazepam) | Possible additive sedation | Low to moderate | Use with caution; monitor for excessive sedation |
| SSRIs / SNRIs (e.g., sertraline, venlafaxine) | SERT inhibition overlap | Low | Generally safe; monitor for serotonergic effects |
| Opioid analgesics | Possible additive CNS depression | Low to moderate | Use with caution; avoid high opioid doses |
| CYP3A4 substrates (e.g., simvastatin, ciclosporin) | Theoretical CYP3A4 inhibition | Low at therapeutic doses | Monitor if using narrow therapeutic index drugs |
| Alcohol | Possible additive CNS effects | Low | Moderate alcohol consumption; no absolute contraindication |
Major Interactions
The most clinically relevant interaction concern is with oral anticoagulants, particularly warfarin and other vitamin K antagonists. Some components of lavender oil have demonstrated antiplatelet activity in vitro, which could theoretically potentiate the anticoagulant effect. Although no clinical case reports of significant bleeding events have been documented in patients taking Silexan concurrently with anticoagulants, it is prudent to monitor the International Normalized Ratio (INR) more frequently during the initiation and discontinuation of Silexan therapy in patients on warfarin.
Co-administration with other central nervous system (CNS) depressants, including benzodiazepines, barbiturates, sedative antihistamines, and opioid analgesics, may result in additive sedative effects. While Silexan itself does not cause clinically significant sedation at the recommended dose, the combination with potent CNS depressants should be approached with awareness of this possibility, particularly in elderly patients who may be more susceptible to CNS depression.
Minor Interactions
The interaction between Silexan and selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) is considered to be of low clinical significance. Although Silexan inhibits the serotonin transporter (SERT) in vitro, the degree of inhibition at the therapeutic dose is substantially lower than that of SSRIs. In clinical trials where patients were permitted to take concomitant SSRI therapy, no cases of serotonin syndrome or other serotonergic adverse effects were reported.
Herbal supplements including St. John's Wort (Hypericum perforatum), valerian (Valeriana officinalis), and kava (Piper methysticum) may have additive effects when taken concurrently with Silexan. Patients should inform their healthcare provider about all herbal supplements they are using to allow for appropriate monitoring and dose adjustments if necessary.
What Is the Correct Dosage of Lavendelolja Schwabe?
The dosage of Lavendelolja Schwabe has been established through a series of well-designed randomized controlled trials. The standard therapeutic dose that demonstrated consistent anxiolytic efficacy across multiple studies is 80 mg (one soft capsule) taken once daily. Some studies have also evaluated a higher dose of 160 mg (two capsules) daily, which showed enhanced efficacy in certain patient subgroups without a significant increase in adverse effects.
| Patient Group | Recommended Dose | Frequency | Notes |
|---|---|---|---|
| Adults (18-64 years) | 80 mg (1 capsule) | Once daily | May increase to 160 mg under medical supervision |
| Elderly (65+ years) | 80 mg (1 capsule) | Once daily | No dose adjustment required; start low and monitor |
| Children (<18 years) | Not recommended | N/A | Insufficient safety data in pediatric populations |
| Hepatic impairment | 80 mg (1 capsule) | Once daily | Use with caution in severe impairment; monitor liver function |
| Renal impairment | 80 mg (1 capsule) | Once daily | No dose adjustment required |
Adults
For adults aged 18 to 64 years, the recommended starting and maintenance dose is one soft capsule (80 mg) taken once daily. The capsule should be swallowed whole with a sufficient amount of water (at least half a glass). It should not be chewed, crushed, or opened, as this would release the essential oil directly into the oral cavity, potentially causing irritation of the mucous membranes and an unpleasant taste experience.
Lavendelolja Schwabe can be taken with or without food. However, taking the capsule with a meal or a snack may help reduce the incidence of gastrointestinal side effects, particularly eructation (burping) with a lavender taste. For optimal consistency, patients are advised to take the capsule at approximately the same time each day.
In patients with insufficient response after 2 to 4 weeks at 80 mg daily, the dose may be increased to 160 mg daily (two capsules) under the supervision of a healthcare provider. This higher dose has been studied in clinical trials and was found to be well tolerated, although gastrointestinal side effects may be slightly more frequent.
Children
Lavendelolja Schwabe is not recommended for use in children and adolescents under 18 years of age. The clinical development program for Silexan focused exclusively on adult populations, and no controlled clinical trials have been conducted in pediatric patients. The safety, tolerability, and appropriate dosing of Silexan in children remain to be established. Parents or caregivers should consult a pediatric healthcare provider for appropriate alternatives to manage anxiety symptoms in young patients.
Elderly
No specific dose adjustment is required for elderly patients (65 years and older). In clinical trials that included elderly participants, Silexan 80 mg daily was well tolerated without an increased incidence of adverse events compared to younger adults. However, as with all medications in elderly patients, careful monitoring is advisable, particularly at the start of treatment, to ensure good tolerability. The lack of sedative effects and cognitive impairment makes Silexan particularly suitable for elderly patients, who are often more vulnerable to the adverse effects of conventional anxiolytics such as benzodiazepines.
Missed Dose
If you miss a dose of Lavendelolja Schwabe, take it as soon as you remember on the same day. If it is already close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Because Silexan has a relatively long duration of action and accumulates to steady state over several days of regular dosing, missing a single dose is unlikely to result in a significant return of anxiety symptoms.
Overdose
There is limited clinical data on overdose with Silexan. In clinical trials, doses up to 160 mg daily were well tolerated. Based on the pharmacological profile and the generally favorable safety margins of plant-derived essential oils, significant toxicity from an acute overdose of Lavendelolja Schwabe is considered unlikely at doses within a reasonable range above the therapeutic dose. However, ingestion of large quantities could potentially cause gastrointestinal symptoms including nausea, vomiting, and abdominal pain.
Contact your healthcare provider or local poison control center immediately. There is no specific antidote for Silexan overdose. Management is symptomatic and supportive, focusing on gastrointestinal decontamination if appropriate and monitoring for adverse effects.
What Are the Side Effects of Lavendelolja Schwabe?
The safety profile of Silexan has been thoroughly evaluated in multiple randomized controlled trials involving thousands of patients. Overall, Lavendelolja Schwabe is well tolerated, with a side effect profile that compares favorably to both placebo and conventional anxiolytic medications. The majority of adverse events reported in clinical trials were mild to moderate in severity and gastrointestinal in nature.
Unlike benzodiazepines and other GABA-ergic anxiolytics, Silexan does not cause clinically significant sedation, daytime drowsiness, or impairment of psychomotor function. This has been confirmed in several studies, including a driving performance study that showed no impairment of driving ability at the therapeutic dose. Furthermore, no cases of physical dependence, tolerance development, or withdrawal symptoms have been observed in clinical trials lasting up to 10 weeks, and post-marketing surveillance data support the favorable long-term safety profile.
Common
- Eructation (burping) with lavender taste
- Nausea
- Abdominal discomfort or pain
- Dyspepsia (indigestion)
Uncommon
- Allergic skin reactions (rash, itching, urticaria)
- Flatulence
- Diarrhea or constipation
- Headache
Rare
- Contact dermatitis (with skin exposure to capsule contents)
- Severe hypersensitivity reactions (angioedema, anaphylaxis)
- Dizziness
- Taste disturbance
The gastrointestinal side effects, particularly eructation with a lavender taste, are attributable to the volatile nature of the essential oil. When the soft capsule dissolves in the stomach, some of the lavender oil may reflux into the esophagus, producing a characteristic taste and smell. This effect is typically most noticeable in the first few days of treatment and tends to diminish as the body adjusts. Taking the capsule with food, particularly with a meal containing some fat, can help reduce the frequency and intensity of this side effect.
In head-to-head trials comparing Silexan 80 mg to lorazepam 0.5 mg, the overall incidence of adverse events was comparable between the two treatments. However, the types of adverse events differed substantially. Lorazepam was associated with sedation, drowsiness, and fatigue, while Silexan was primarily associated with gastrointestinal effects. No cases of rebound anxiety or withdrawal phenomena were observed upon discontinuation of Silexan, in contrast to the well-documented withdrawal syndrome associated with benzodiazepine discontinuation.
Contact your healthcare provider if you experience any side effect that is severe, persistent, or concerning. Seek immediate medical attention if you develop signs of a severe allergic reaction, including difficulty breathing, swelling of the face or throat, or widespread skin rash. Report all suspected adverse drug reactions to your national pharmacovigilance authority.
How Should You Store Lavendelolja Schwabe?
Proper storage of Lavendelolja Schwabe is essential to maintain the stability, potency, and safety of the preparation throughout its shelf life. As the active ingredient is a volatile essential oil, the capsules are particularly sensitive to environmental conditions that could affect the integrity of the oil and the capsule shell.
The soft capsules should be stored at a temperature not exceeding 25°C (77°F). Exposure to excessive heat can cause the gelatin capsule shell to soften, stick together, or deform, and can also accelerate the degradation of the volatile terpene components of the lavender oil. Similarly, exposure to direct sunlight or UV radiation should be avoided, as light can initiate photochemical degradation reactions that may alter the composition of the essential oil and reduce its therapeutic potency.
Moisture is another environmental factor that can affect the stability of soft gelatin capsules. The capsules should be stored in their original blister packaging until ready for use, and the packaging should be kept tightly sealed. High humidity environments, such as bathrooms, should be avoided as storage locations. If the capsules appear swollen, discolored, or have an unusual odor, they should not be used and should be returned to a pharmacy for proper disposal.
As with all medications, Lavendelolja Schwabe should be kept out of the reach and sight of children. The soft capsules should not be stored alongside food or beverages to prevent accidental ingestion. Do not use any capsules after the expiry date printed on the blister packaging and the outer carton. Expired medications should be disposed of according to local pharmaceutical waste disposal guidelines; do not flush them down the toilet or throw them in household waste unless specifically instructed to do so.
What Does Lavendelolja Schwabe Contain?
Active Ingredient
The active pharmaceutical ingredient in Lavendelolja Schwabe is Silexan, a proprietary preparation of essential oil obtained by steam distillation from the fresh flowering tops of Lavandula angustifolia Mill. (narrow-leaved lavender, also known as English lavender or true lavender). Each soft capsule contains 80 mg of this standardized oil.
Silexan is characterized by a defined phytochemical profile with the following principal constituents:
- Linalool (36-53%): A monoterpene alcohol that is the primary active compound responsible for the anxiolytic and neuroprotective effects. Linalool modulates voltage-dependent calcium channels and has demonstrated anti-inflammatory properties.
- Linalyl acetate (34-45%): An ester of linalool that contributes to the anxiolytic activity and provides the characteristic lavender aroma. It has shown muscle-relaxant properties in preclinical studies.
- 1,8-Cineole (eucalyptol): Present in small quantities, contributing to the overall pharmacological profile.
- Terpinen-4-ol: A minor constituent with antimicrobial properties.
- Camphor: Present in trace amounts; the low camphor content distinguishes medicinal-grade L. angustifolia oil from other lavender species.
Excipients
The soft gelatin capsule shell and additional excipients in Lavendelolja Schwabe typically include:
- Gelatin: Forms the capsule shell; derived from animal collagen (not suitable for strict vegetarians or vegans).
- Glycerol (E422): Used as a plasticizer to maintain capsule flexibility.
- Sorbitol (E420): A sugar alcohol used as a humectant; patients with fructose intolerance should be aware of its presence.
- Rapeseed oil: A carrier oil within the capsule formulation.
- Iron oxide (E172): Used as a coloring agent for the capsule shell.
- Titanium dioxide (E171): An opacifier in the capsule shell; regulations regarding this excipient vary by country.
Patients with known allergies or intolerances to any of these excipients should consult their pharmacist or healthcare provider before taking Lavendelolja Schwabe. The product does not contain lactose, gluten, or artificial preservatives.
Frequently Asked Questions About Lavendelolja Schwabe
Medical References & Sources
All medical information is based on peer-reviewed sources, international guidelines, and regulatory agency assessments. Evidence level: 1A (systematic reviews and meta-analyses of randomized controlled trials).
- Kasper S, Gastpar M, Muller WE, et al. Silexan, an orally administered Lavandula oil preparation, is effective in the treatment of 'subsyndromal' anxiety disorder: a randomized, double-blind, placebo controlled trial. Int Clin Psychopharmacol. 2010;25(5):277-287.
- Woelk H, Schlafke S. A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine. 2010;17(2):94-99.
- Kasper S, Gastpar M, Muller WE, et al. Lavender oil preparation Silexan is effective in generalized anxiety disorder - a randomized, double-blind comparison to placebo and paroxetine. Int J Neuropsychopharmacol. 2014;17(6):859-869.
- European Medicines Agency (EMA). Community herbal monograph on Lavandula angustifolia Mill., aetheroleum. HMPC Assessment Report. EMA/HMPC/143183/2010.
- Baldinger P, Hoflich AS, Bauer M, et al. Effects of Silexan on the serotonin-1A receptor and microstructure of the human brain: a randomized, placebo-controlled, double-blind, cross-over study with molecular and structural neuroimaging. Int J Neuropsychopharmacol. 2015;18(4):pyu063.
- Kasper S, Muller WE, Volz HP, et al. Silexan in anxiety disorders: Clinical data and pharmacological background. World J Biol Psychiatry. 2018;19(6):412-420.
- Generoso MB, Soares A, Taiar IT, et al. Lavender oil preparation (Silexan) for treating anxiety: An updated meta-analysis. J Clin Psychopharmacol. 2022;42(6):568-576.
- World Health Organization (WHO). WHO Monographs on Selected Medicinal Plants - Aetheroleum Lavandulae. WHO, Geneva.
- British National Formulary (BNF). Herbal Medicines - Lavender Oil. National Institute for Health and Care Excellence (NICE).
- Schuwald AM, Noldner M, Wilmes T, et al. Lavender oil-potent anxiolytic properties via modulating voltage dependent calcium channels. PLoS One. 2013;8(4):e59998.
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