Perinatal EvidenceCompass
Prepopulated workbenchMED-050

Antidepressants — perinatal neuroactive steroid

Zuranolone

FDA-approved treatment of postpartum depression in adults

Brand / product examples: Zurzuvae

Not a categorical safety rating

This record organizes questions; it does not close them.

The clinical fields and position statements are prepopulated from the public-source corpus. They have not completed individual dual extraction, formal appraisal, exact-label reconciliation, or multidisciplinary sign-off. Do not use this page to justify abrupt discontinuation or reflexive switching.

Inventory identity

What this record represents

Canonical generic name
Zuranolone
Entity type
single-ingredient drug
Active component(s)
Zuranolone
Formulation / route / interval
Oral capsule; 14-day treatment course
Attachment entry
Zuranolone
Separate monograph status
Yes — current oral neuroactive-steroid product
Identity and cross-reference
Not populated in v0.95
Inventory verification confidence
Moderate — molecule-level source; exact product/jurisdiction pending

Decision taxonomy

Five positions kept separate

These are workbench statements for reviewer execution. They are not independently commissioned, patient-specific recommendations.

  1. 01

    Stable continuation

    Workbench statement

    Do not withhold or discontinue solely because of pregnancy or lactation. For this record, assess indication, prior response, relapse severity, dose/formulation, alternatives, exposure timing, and mapped evidence; individual commissioned adjudication remains pending.

  2. 02

    New initiation in pregnancy

    Workbench statement

    For a new start, prefer an effective option with the strongest diagnosis-specific efficacy and reproductive evidence when clinically suitable. This record has not received an individual, independently verified initiation ranking.

  3. 03

    Switch before conception

    Workbench statement

    Before conception, consider a switch only when expected benefit exceeds relapse, withdrawal, failed-switch, and dual-exposure risks. Build and monitor the plan before pregnancy when feasible; no universal switch direction is assigned here.

  4. 04

    Unplanned exposure

    Workbench statement

    After unplanned exposure, confirm product, route, dose, timing, indication, co-exposures, and symptoms; do not advise abrupt cessation. Use the mapped evidence and current label to decide whether any targeted fetal assessment is indicated.

  5. 05

    Delivery, postpartum & lactation

    Workbench statement

    Create separate delivery, postpartum-dose, neonatal-observation, and lactation plans. Do not infer breastfeeding suitability from pregnancy evidence or routinely taper before delivery without drug-specific support.

Linked evidence

3 mapped claim summaries

Mapping can include class-wide, framework, formulation, regulatory, or evidence-gap claims. A linked claim is not necessarily a drug-specific causal estimate.

A-024Provisional public source

A zuranolone milk study found very low transfer, but did not establish breastfed-infant safety.

Public-source certainty descriptor
moderate for milk transfer; insufficient for infant outcomes; not GRADE
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
postpartum 14-day course
Comparator
no infant comparator
Effect or numbers carried forward

n=14; mean RID 0.357%; maximum calculated RID below 1%.

Limitations

Milk was not necessarily fed to infants; no direct infant clinical or neurodevelopmental outcomes.

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
A-025Provisional public source

ACOG's 2026 Clinical Practice Update provides focused revised guidance for brexanolone and zuranolone in postpartum depression with onset in the third trimester or within four weeks postpartum; it is a focused update, not a wholesale revision of CPG No. 5.

Public-source certainty descriptor
high for scope and status
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
third trimester and postpartum
Comparator
not applicable
Effect or numbers carried forward

No reliable quantitative estimate.

Limitations

The public summary does not substitute for all product-specific counseling; brexanolone US approval is withdrawn.

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
A-067Provisional public source

FDA prescription labeling uses narrative Pregnancy and Lactation Labeling Rule sections rather than the former A/B/C/D/X letter categories.

Public-source certainty descriptor
high for US regulatory framework
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
pregnancy and lactation
Comparator
not applicable
Effect or numbers carried forward

No reliable quantitative estimate.

Limitations

Exact labeling and revision date remain product-specific; non-US systems differ.

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending