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zuranolone

Last reviewed 2026-02-12

Reviewed by PsychMed Editorial Team.

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Adjunctive therapy

Brands: Zurzuvae

Sources updated 2026 • 4 references

Quick summary

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 and 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 and 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

  1. ZURZUVAE (zuranolone) capsules prescribing information — DailyMed (2026)
  2. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial — JAMA Psychiatry (2021)
  3. Zuranolone for the Treatment of Postpartum Depression — The American Journal of Psychiatry (2023)
  4. Pharmacotherapy of Postpartum Depression: Current Approaches and Novel Drug Development — CNS Drugs (2019)
zuranolone (Zurzuvae) — PsychMed