Mechanism #
Positive allosteric modulation of GABA-A receptors.
Clinical distinction #
Selected US label treats adult postpartum depression with a time-limited oral course.
Monitoring and warnings #
Driving impairment, CNS depression and embryo-fetal toxicity; renal/hepatic restrictions and CYP3A4 interactions require review.
Formulation scope #
Oral capsule; distinct from intravenous brexanolone.
Dose reference #
| Indication | Population | Formulation / route | Jurisdiction | Reference |
|---|---|---|---|---|
| Postpartum depression | Adults; general label population only. See separate impairment/age restrictions. | oral capsule · oral | United States | Adult selected-label course: 50 mg each evening for fourteen days with fat-containing food. CNS effects, renal/hepatic impairment and interactions have separate reduced-dose references. |
Special populations & counseling #
Age, renal and hepatic function, pregnancy, breastfeeding, co-medication and the treatment indication require medicine-specific review. A general class statement cannot establish suitability for an individual.
Discuss the intended benefit, expected review plan, relevant adverse effects, driving or falls considerations, and how to obtain help. Stopping, switching or restarting requires the exact product’s instructions and clinical assessment.
Brands & products #
Supplied catalogue observations; price dates may be unknown. Presence does not establish current stock or Indian approval.
Reference coverage #
Ingredient profiles and product records are separate. Details not supplied in this reference must be checked in the exact product information; missing information is not evidence of absence or safety.
References · 3
- DailyMed structured product information · Retrieved 2026-10-07
- MHRA product information · Retrieved 2026-10-07
- CDSCO approved new drugs · Retrieved 2026-10-07