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zuranolone

Adjunctive therapy

Brand: Zurzuvae

Published 2026-02-15 · Last reviewed 2026-02-22 · 4 references

Content sourced from FDA labeling (DailyMed) and peer-reviewed literature.

Print sheet Review evidence

At a glance

Class: Adjunctive therapy·Typical dose: Recommended dosage is 50 mg once daily in the evening for 14 days, taken with fat-containing food (label).·Half-life: Single-dose range 19.7–24.6 h·LAI available: No

Class: Adjunctive therapy
Typical dose: Recommended dosage is 50 mg once daily in the evening for 14 days, taken with fat-containing food (label).
Half-life: Single-dose range 19.7–24.6 h
LAI available: No

Quick answers

What is zuranolone?: Zuranolone (brand Zurzuvae) is a neuroactive steroid and GABA-A receptor positive allosteric modulator approved for postpartum depression (PPD) in adults (label).
What is Zurzuvae?: Zurzuvae is a brand name for zuranolone.
What is Zurzuvae (zuranolone) used for?: Label indications include: Postpartum depression (adults) (label).
What drug class is Zurzuvae (zuranolone)?: Neuroactive Steroid.
What is the mechanism of action of Zurzuvae (zuranolone)?: Neuroactive steroid and GABA-A receptor positive allosteric modulator. FDA-approved as a 14-day oral treatment course for postpartum depression (label).
What strengths does Zurzuvae (zuranolone) come in?: Oral capsules (label): 20 mg, 25 mg, 30 mg.

General information

Zuranolone (brand Zurzuvae) is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator approved for postpartum depression (PPD) in adults (label).

The labeled regimen is a short 14-day course taken once daily in the evening with fat-containing food. Clinical trials show symptom improvement versus placebo during the dosing window and follow-up period (label/trial).

Zuranolone has a boxed warning for driving impairment due to CNS depressant effects; safety planning includes avoiding driving and other hazardous activities until at least 12 hours after dosing (label).

It is a controlled substance (Schedule IV in the U.S.; “CIV” on label), and the label describes potential for physical dependence and withdrawal-like symptoms if used at higher dose or longer duration than recommended (label).

The compare view, zuranolone evidence feed, and zuranolone print page support counseling when rapid symptom change and functional safety are central concerns.

U.S. approvals

Postpartum depression (adults) (label)

Formulations & strengths

Oral capsules (label): 20 mg, 25 mg, 30 mg.

Generic availability

Brand-only (no generic equivalent as of initial approval).

Postpartum depression care often requires rapid symptom relief, safety planning for sedation and driving restrictions, and coordinated support (sleep, caregiving, and therapy). Access and payer authorization may be practical barriers for some patients.

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Mechanism of action

Refer to the Glossary entry on Neurotransmitters for background on receptor systems involved in serious mental illness.

Positive allosteric modulator of GABA-A receptors, shifting inhibitory neurotransmission in a way that can reduce depressive symptoms in some patients (label/mechanism).

Neurosteroid-based GABAergic modulation is a distinct mechanism from SSRIs/SNRIs and is one reason zuranolone is discussed as a rapid-onset postpartum depression option (mechanism/clinical).

GABA-A positive allosteric modulation (neuroactive steroid).

Metabolism & pharmacokinetics

Extensively metabolized; CYP3A4 is identified as a primary enzyme involved (label).
Terminal half-life is approximately 19.7 to 24.6 hours in adults (label).
After radiolabeled dosing, ~45% recovered in urine and ~41% in feces as metabolites; negligible unchanged drug recovered in urine and <2% in feces (label).

Dosing & administration

Recommended dosage is 50 mg once daily in the evening for 14 days, taken with fat-containing food (label).
If CNS depressant effects occur, labeling allows dose reduction to 40 mg once daily within the 14-day course (label).
Reduce dose to 30 mg once daily for 14 days in severe hepatic impairment, moderate/severe renal impairment, or when co-administered with strong CYP3A4 inhibitors (label).

Monitoring & labs

Counsel on driving restrictions (boxed warning) and assess next-morning sedation or confusion during the 14-day course (label).
Avoid alcohol and other CNS depressants; review other sedating medications and adjust the regimen when feasible (label/clinical).
Monitor mood and suicidality as part of standard depression care, and ensure a practical support plan for sleep and infant-care needs (label/clinical).
Re-check renal/hepatic status and CYP3A4 interactions to ensure the labeled dose is used (label).

Adverse effects

FDA boxed warnings

Impaired ability to drive or engage in other potentially hazardous activities due to CNS depressant effects; avoid driving until at least 12 hours after administration (label).

Common side effects (≥10%)

Somnolence / sedation: Can impair driving and work safety; risk increases with alcohol and other CNS depressants (label).
Dizziness / confusion: Confusion and gait disturbance can occur; dose reduction or discontinuation may be needed if severe (label).
Next-morning driving impairment: Driving simulation studies show impairment; patients may not be able to assess their own impairment (label).

Other notable effects

Suicidal thoughts and behavior are listed as a warning; monitoring for worsening depression and suicidality is part of standard care (label).
Embryo-fetal risk: animal data show developmental toxicity; label warns it may cause fetal harm when administered during pregnancy (label).
Potential for physical dependence: label describes withdrawal-like symptoms after discontinuation in healthy subjects and notes risk is not fully characterized at higher dose/longer duration (label).

Interactions

Alcohol and other CNS depressants (including benzodiazepines) can worsen psychomotor impairment and sedation (label).
Strong CYP3A4 inhibitors increase exposure and require dose reduction; strong CYP3A4 inducers reduce exposure and are avoided (label).

Other useful information

Zuranolone can be used alone or as an adjunct to oral antidepressant therapy (label).
Postpartum depression treatment planning often pairs medication with supportive interventions (sleep support, psychotherapy access, caregiver planning), given the functional demands of early postpartum periods (clinical).

References

Related hubs:SMI toolkit·Support resources