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NERVOUS SYSTEM › PSYCHOLEPTICS › ANXIOLYTICS › Benzodiazepine derivatives
tofisopam
N05BA23
Forms & Strengths
- Oral tablets 50 mg
- Oral tablets 100 mg
Adult Dosing
- Standard dose: 50 mg to 100 mg orally 3 times daily
- Maximum daily dose: 300 mg
- Adjust dose in elderly or renal impairment as clinically indicated
Pediatric Dosing
- Safety and efficacy in pediatric patients not established
Indications
- Anxiety disorders
- Neurovegetative symptoms associated with emotional stress
- Alcohol withdrawal syndrome (adjunctive)
Mechanism of Action
- Atypical 2,3-benzodiazepine derivative
- Binds to benzodiazepine sites on GABA-A receptors with distinct pharmacological profile
- Lacks significant sedative, hypnotic, muscle relaxant, and anticonvulsant properties
- Exerts autonomic-regulating and psychovegetative effects
Contraindications
- Hypersensitivity to tofisopam or other benzodiazepines
- Severe respiratory depression
- Coma
- Acute narrow-angle glaucoma
- Severe hepatic impairment
- Pregnancy (first trimester) and lactation
Adverse Reactions
- Fatigue
- Headache
- Nausea
- Dry mouth
- Sleep disturbances
- Skin rash
- Mild agitation or irritability
Drug Interactions
- CNS depressants (alcohol, opioids, sedatives) enhance sedative effects
- CYP3A4 inhibitors may increase plasma concentrations of tofisopam
- CYP3A4 inducers may decrease plasma concentrations of tofisopam
- May inhibit CYP3A4, potentially increasing levels of co-administered substrates
Curated Content: Needs Vetting Before Put to Clinical Use