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Fabomotizole

Other anxiolytics (local classification)

ATC code: N05BX-AFOBAZOLE

Updated · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Generalized anxiety disorder

Not recommended

Fabomotizole (brand name Afobazole) is an anxiolytic marketed in Russia as a "mild" anti-anxiety option, including for generalized anxiety disorder. Studies have not shown convincing benefit for this use: international guidelines and evidence reviews do not cover it, and there are no quality RCTs that confirm an effect. For generalized anxiety disorder, the approaches with proven benefit are cognitive behavioral therapy and antidepressants from the SSRI or SNRI groups. Fabomotizole should not replace them, because swapping proven treatment for this drug risks losing time without real help

Sources

  1. Ter Arkh: [Evaluation of the therapeutic efficacy and safety of the selective anxiolytic afobazole in generalized anxiety disorder and adjustment disorders: Results of a multicenter randomized comparative study of diazepam]. (2016)
  2. Kardiologiia: [The Possibility of Correcting Anxiety Symptoms in Cardiac Patients in Primary Care Settings: Results of the Therapeutic Part of a Russian Multicenter Study COMETA]. (2019)
  3. Am J Ther: Therapeutic Interventions for Adjustment Disorder: A Systematic Review. (2020)

ICD-10: F41.1 · ICD-11: 6B00

D

Insomnia and sleep disorders

Not recommended

Fabomotizole is an anxiolytic promoted to ease anxiety and also marketed for sleep problems. For insomnia specifically it has not shown convincing benefit, and there is no solid evidence base for this use. For chronic insomnia, international guidelines put cognitive behavioral therapy for insomnia (CBT-I) first, with a clinician choosing a sleep medication for short-term use when needed. The substance itself is harmless in this role, but do not take it instead of a treatment with proven benefit, since that risks missing real care. Decide together with your doctor

Sources

  1. AASM: Behavioral and psychological treatments for chronic insomnia disorder in adults (2021)
  2. AASM: Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults (2017)

ICD-10: G47.0 · ICD-11: 7A00

D

Stress and anxiety

Not recommended

Fabomotizole is an anxiolytic sold and promoted in Russia for relief of stress and anxiety. Convincing benefit for this use has not been shown: international guidelines and reviews do not mention the drug, and the available data are too weak to support an effect. In this use the substance is well tolerated and carries no known harm, but there is little reason to expect help from it. For persistent anxiety, psychotherapy (cognitive behavioral therapy in particular) and medicines with an established evidence base, chosen by a doctor, are what work.

Sources

  1. Ter Arkh: [Evaluation of the therapeutic efficacy and safety of the selective anxiolytic afobazole in generalized anxiety disorder and adjustment disorders: Results of a multicenter randomized comparative study of diazepam]. (2016)
  2. Am J Ther: Therapeutic Interventions for Adjustment Disorder: A Systematic Review. (2020)

ICD-10: F41.9 · ICD-11: 6B0Z

F

Premenstrual syndrome

Not recommended

For PMS, 2023 and international guidelines recommend CBT, selective serotonin reuptake inhibitors (sertraline, fluoxetine, citalopram) for marked symptoms, and combined oral contraceptives. Afobazole is not included.

Sources

  1. BJOG: An International Journal of Obstetrics & Gynaecology: Management of Premenstrual Syndrome (2016)
  2. Cochrane Database Syst Rev: Selective serotonin reuptake inhibitors for premenstrual syndrome. (2013)

ICD-10: N94.3 · ICD-11: GA34.40

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

The manufacturer claims selective anxiolytic action without sedation or muscle relaxation via sigma-1 receptor interaction. The molecule is registered only in Russia and a few CIS countries. Fabomotizole has not been studied in PubMed-indexed RCTs with adequate methodology. International anxiety disorder guidelines ( 2023, CG113) do not include the drug.

Safety

Contraindications

  • Hypersensitivity to any component
  • Pregnancy and breastfeeding
  • Age under 18 years
  • Lactose intolerance, lactase deficiency, glucose-galactose malabsorption

Serious adverse effects

  • No independent post-marketing safety studies are available

Common adverse effects

  • Per manufacturer label: allergic reactions, rarely headache

Pregnancy: can you take Fabomotizole?

Contraindicated in pregnancy.

Breastfeeding: can you take Fabomotizole?

Contraindicated during breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

Afobazole is sold over-the-counter in Russia and promoted in TV advertising as a safe alternative to benzodiazepines. The drug is registered only in CIS countries. The international pharmaceutical industry has not replicated the molecule: no RCTs in PubMed, no or submissions.

Common myths

Myth: 'Afobazole does not cause dependence, so it is safer than benzodiazepines'. Fact: for a drug with unproven efficacy, 'no side effects' often means 'neither effect nor data'. Benzodiazepines cause dependence because they genuinely act on GABA receptors. The safety of an alternative must be evaluated against demonstrated benefit, not a marketing claim.

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Frequently asked

What is Fabomotizole used for?

Fabomotizole is evaluated for the following indications with varying evidence strength: Generalized anxiety disorder (evidence tier D), Stress and anxiety (evidence tier D), Insomnia and sleep disorders (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Fabomotizole?

Common side effects of Fabomotizole (≥ 1 in 100): Per manufacturer label: allergic reactions, rarely headache. See the Safety section for uncommon and serious reactions.

Is Fabomotizole safe during pregnancy?

Contraindicated in pregnancy.

Is Fabomotizole compatible with breastfeeding?

Contraindicated during breastfeeding.

Who should not take Fabomotizole?

Fabomotizole is contraindicated in: Hypersensitivity to any component; Pregnancy and breastfeeding; Age under 18 years; Lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Full list in the Safety section.

Afobazole does not cause dependence, so it is safer than benzodiazepines

for a drug with unproven efficacy, 'no side effects' often means 'neither effect nor data'. Benzodiazepines cause dependence because they genuinely act on GABA receptors. The safety of an alternative must be evaluated against demonstrated benefit, not a marketing claim.

Official sources

Direct links to regulator labels. Open in a new tab.

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