Molecule
Zuranolone is a neuroactive steroid gamma-aminobutyric acid A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. It is available as capsules for oral use. MedsAcross supplies Zuranolone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults.
Source: US FDA prescribing information
The mechanism of action of zuranolone in the treatment of PPD is not fully understood but is thought to be related to its positive allosteric modulation of GABA A receptors.
Source: US FDA prescribing information
Administer with fat-containing food. Recommended dosage is 50 mg orally once daily in the evening for 14 days. Dosage may be reduced to 40 mg once daily if CNS depressant effects occur. ZURZUVAE can be used alone or as an adjunct to oral antidepressant therapy. Severe Hepatic Impairment: Recommended dosage is 30 mg orally once daily in the evening for 14 days. Moderate or Severe Renal Impairment: Recommended dosage is 30 mg orally once daily in the evening for 14 days.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (impaired ability to drive or engage in other potentially hazardous activities zurzuvae): causes driving impairment due to central nervous system (CNS) depressant effects. Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. CNS Depressant Effects: ZURZUVAE can cause CNS depressant effects such as somnolence and confusion. If patients develop CNS depression, consider dosage reduction or discontinuation of ZURZUVAE. Suicidal Thoughts and Behavior: Consider changing the therapeutic regimen, including discontinuing ZURZUVAE, in patients whose PPD worsens, or who experience emergent suicidal thoughts and behaviors. Embryo-fetal Toxicity: May cause fetal harm. Advise a pregnant woman of the potential risk to an infant exposed to ZURZUVAE in utero.
Source: US FDA prescribing information
The following adverse reactions are discussed in more detail in other sections of the labeling: Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities Central Nervous System Depressant Effects Suicidal Thoughts and Behavior Most common adverse reactions (incidence ≥5% and greater than placebo) were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
Source: US FDA prescribing information
Table 4 displays clinically important drug interactions with ZURZUVAE. Table 4. Clinically Important Drug Interactions with ZURZUVAE CNS Depressant Drugs and Alcohol Clinical Impact Due to additive pharmacological effects, the concomitant use of CNS depressant drugs, including alcohol, may increase impairment of psychomotor performance or CNS depressant effects. Management If use with another CNS depressant is unavoidable, consider dosage reduction. Caution should be used when ZURZUVAE is administered in combination with other CNS drugs or alcohol. Strong CYP3A4 Inhibitors Clinical Impact Concomitant use of ZURZUVAE with a strong CYP3A4 inhibitor increases the exposure of zuranolone, which may increase the risk of ZURZUVAE-associated adverse reactions. Management Reduce the ZURZUVAE dosage when used with a strong CYP3A4 inhibitor.
Source: US FDA prescribing information
Store at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Zuranolone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zurzuvae 25 mg capsuleOral | Biogen MA | US FDA | Available on request |
| Zurzuvae 20 mg capsuleOral | Biogen MA | US FDA | Available on request |
| Zurzuvae 30 mg capsuleOral | Biogen MA | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Zuranolone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Zuranolone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Zuranolone, including Zurzuvae.
Yes. The US FDA first approved Zuranolone on 4 August 2023, according to Drugs@FDA.
Yes. Zuranolone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Zuranolone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Zuranolone is classified under ATC code N06A (Antidepressant).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.