Other anxiolytics (local classification)
ATC code: N05BX-AFOBAZOLE (Fabomotizole (local code))
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 (APA 2023, NICE CG113) do not include the drug.
Not recommended
International GAD guidelines (APA 2023, NICE CG113, WFSBP 2023) list SSRIs (escitalopram, sertraline, paroxetine) and SNRIs (venlafaxine, duloxetine) as first-line therapy. Fabomotizole is not mentioned. The drug is not registered outside Russia.
Not recommended
Afobazole has no evidence base for sleep disorders. International insomnia guidelines (AASM 2021, NICE CG193) recommend cognitive behavioural therapy (CBT-I) as first-line and, if needed, melatonin agonists or orexin antagonists. Fabomotizole is not mentioned in these documents.
Not recommended
For PMS, ACOG 2023 and RCOG international guidelines recommend CBT, selective serotonin reuptake inhibitors (sertraline, fluoxetine, citalopram) for marked symptoms, and combined oral contraceptives. Afobazole is not included.
Not recommended
'Stress', 'adjustment disorder', and 'nervous tension' are loose marketing categories. For subclinical anxiety, international guidelines recommend psychotherapy (CBT), stress-management techniques, and physical activity rather than prescription or over-the-counter 'calming' drugs.
Contraindicated in pregnancy.
Contraindicated during breastfeeding.
Fabomotizole is evaluated for the following indications with varying evidence strength: Stress and adjustment (marketed indication) (evidence tier F), Insomnia (evidence tier F), Premenstrual syndrome (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Fabomotizole (≥ 1 in 100): Per manufacturer label: allergic reactions, rarely headache. See the Safety section for uncommon and serious reactions.
Contraindicated in pregnancy.
Contraindicated during breastfeeding.
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.
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.