Maternal & Newborn Atlas
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Zurzuvae (zuranolone)

A capsule taken by mouth once a day in the evening for 14 days to treat postpartum depression in adults. FDA approved it in August 2023 and described it as the first oral medicine for postpartum depression. The label has a boxed warning that it can impair the ability to drive and to do other potentially hazardous activities, and FDA says it may cause fetal harm.

  • Product
  • In this atlas

Overview

Technical summary

US NDA217369, approved 2023-08-04 (FDA press announcement and openFDA drugsfda). Capsules of 20 mg, 25 mg and 30 mg (openFDA product list). The current label (effective 2026-06-15, read through openFDA) gives 50 mg by mouth once daily in the evening with fat-containing food for 14 days, with a lower dose if central nervous system depressant effects occur, alone or as an adjunct to oral antidepressant therapy. The label names SKYLARK (NCT04442503) as Study 1 of two efficacy studies. The 2023 press announcement says approval was granted to Sage Therapeutics, Inc.; openFDA now lists BIOGEN as sponsor. This page records what FDA authorised and what the trials found; it is not advice about use. The recipient is the adult postpartum woman.

Product details

Type
Medicine
Model or formulation
Zuranolone oral capsules, 20 mg, 25 mg and 30 mg (openFDA drugsfda product list for NDA217369)
Version
As approved under NDA217369 on 2023-08-04. Label text is the current label effective 2026-06-15 as served by openFDA.

Intended-use sources

  1. Background ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

    Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13. · SPL set id: f18e53b0-d0bb-422d-8de7-ab64b7292b29

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-06-15
    Source state
    Current
    Snapshot hash
    f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869
    Reuse basis
    openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.

  2. Background FDA approves first oral treatment for postpartum depression (FDA press announcement)

    Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2023-08-22
    Source state
    Current
    Snapshot hash
    ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
    Reuse basis
    FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

Claims and evidence

Context Adults with postpartum depression (labelled use of Zurzuvae, United States)

Recipient
Maternal
Population
Adults with postpartum depression, as the label words the indication. FDA describes the supporting trials as enrolling women who met DSM criteria for a major depressive episode with onset of symptoms in the third trimester or within four weeks of delivery.
Care setting
Prescription medicine taken by mouth (openFDA marketing status Prescription).
Geography
United States (FDA)
Life stage
Postpartum
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory context)
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Adults with postpartum depression
Excluded
  • Not stated in the parts of the label read for this record; see the label for contraindications and warnings

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA approved Zurzuvae (zuranolone) capsules under NDA217369 on 4 August 2023, for the treatment of postpartum depression (PPD) in adults. FDA described it as the first oral medication indicated to treat PPD in adults; before it, FDA said, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities. The current label gives a recommended dose of 50 mg by mouth once a day in the evening for 14 days and carries a boxed warning about impaired ability to drive and engage in other potentially hazardous activities.

    Applies to Maternal
    • Adults with postpartum depression, as the label words the indication. FDA describes the supporting trials as enrolling women who met DSM criteria for a major depressive episode with onset of symptoms in the third trimester or within four weeks of delivery.
    • Prescription medicine taken by mouth (openFDA marketing status Prescription).
    • United States (FDA)
    • Postpartum
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory context)
    Certainty method
    Not assessed
    Limitations
    An approval is an FDA decision about a product. It is not an FDA recommendation to use the medicine for any person, and this record does not describe who should or should not take it. FDA's 2023 press announcement says approval was granted to Sage Therapeutics, Inc., and openFDA now lists the application sponsor as BIOGEN; the atlas does not trace the change. Label wording comes from today's label text in openFDA (label effective 2026-06-15), not from the 2023 label. openFDA says its data is unvalidated.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (12)

    1. Supports FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Press announcement date line
      How it applies
      Date of FDA's announcement of the approval.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    2. Supports FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Paragraph 1, sentence 1
      How it applies
      FDA statement of the approval and indication.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    3. Supports FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Paragraph 1, sentence 3
      How it applies
      FDA statement that treatment was only available as an IV injection until then.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    4. Supports openFDA drugsfda record for NDA217369

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14. · NDA: NDA217369

      Locator
      results[0].application_number
      How it applies
      Application number in openFDA.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a
      Reuse basis
      openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA217369.json. openFDA says its data is unvalidated and not for medical decisions.

    5. Supports openFDA drugsfda record for NDA217369

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14. · NDA: NDA217369

      Locator
      results[0].products[0].brand_name
      How it applies
      Brand name in openFDA.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a
      Reuse basis
      openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA217369.json. openFDA says its data is unvalidated and not for medical decisions.

    6. Supports openFDA drugsfda record for NDA217369

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14. · NDA: NDA217369

      Locator
      results[0].submissions[1].submission_status_date
      How it applies
      Date of the original submission action in openFDA (2023-08-04).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a
      Reuse basis
      openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA217369.json. openFDA says its data is unvalidated and not for medical decisions.

    7. Supports ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13. · SPL set id: f18e53b0-d0bb-422d-8de7-ab64b7292b29

      Locator
      results[0].indications_and_usage[0]
      How it applies
      Indication in the current label.
      Retrieved
      Source effective date
      2026-06-15
      Source state
      Current
      Snapshot hash
      f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.

    8. Supports ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13. · SPL set id: f18e53b0-d0bb-422d-8de7-ab64b7292b29

      Locator
      results[0].dosage_and_administration[0], 2.1
      How it applies
      Recommended dose in the current label.
      Retrieved
      Source effective date
      2026-06-15
      Source state
      Current
      Snapshot hash
      f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.

    9. Supports ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13. · SPL set id: f18e53b0-d0bb-422d-8de7-ab64b7292b29

      Locator
      results[0].boxed_warning[0]
      How it applies
      Boxed warning in the current label.
      Retrieved
      Source effective date
      2026-06-15
      Source state
      Current
      Snapshot hash
      f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.

    10. Supports FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Paragraph 5, sentence 1
      How it applies
      FDA press statement about the boxed warning.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    11. Background FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Paragraph 8, last sentence
      How it applies
      Approval holder named in 2023.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    12. Background openFDA drugsfda record for NDA217369

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14. · NDA: NDA217369

      Locator
      results[0].sponsor_name
      How it applies
      Sponsor listed in openFDA now.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a
      Reuse basis
      openFDA license page (fetched as mj-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The raw record is committed at research/snapshots/mj-openfda-drugsfda-NDA217369.json. openFDA says its data is unvalidated and not for medical decisions.

Context Women aged 18 to 45 years with severe postpartum depression, 14-day oral course (SKYLARK, 2023)

Recipient
Maternal
Population
Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.
Care setting
Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.
Geography
United States, Spain and United Kingdom (registry locations)
Life stage
Postpartum. The abstract and the registry fields read give no postnatal age limits.
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).
Eligibility: 2 inclusion criteria; 1 exclusion criterion
Included
  • Women aged 18 to 45 years (registry)
  • Severe postpartum depression (abstract)
Excluded
  • Not stated in the parts of the abstract and registry fields that were read

  • Effect Interventional Certainty not assessed

    FDA states that the efficacy of Zurzuvae in adults with postpartum depression was shown in two randomized, double-blind, placebo-controlled, multicenter studies. The primary endpoint was the change in HAMD-17 total score at day 15, and the Zurzuvae groups showed significantly more improvement than the placebo groups. The current label names the first of the two studies (Study 1) as NCT04442503, the SKYLARK trial, whose published abstract reports -15.6 points with zuranolone 50 mg against -11.6 with placebo (difference -4.0, 95% CI -6.3 to -1.7). The label's recommended dose is 50 mg by mouth once a day in the evening for 14 days.

    Source problem. A cited source is corrected. Check the sources before relying on this claim.

    Applies to Maternal
    • Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.
    • Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.
    • United States, Spain and United Kingdom (registry locations)
    • Postpartum. The abstract and the registry fields read give no postnatal age limits.
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up 45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).
    Certainty method
    Not assessed
    Limitations
    This claim rests on FDA's press announcement of 2023 and the current label text in openFDA, plus the SKYLARK abstract. The label's Study 2 (NCT02978326) tested another zuranolone capsule formulation, approximately equivalent to 40 mg of Zurzuvae, and is not recorded in this atlas. The label and the abstract give different participant counts for Study 1, and the atlas does not reconcile them. The press announcement gives no numbers. The population is severe postpartum depression in the SKYLARK abstract and adults with postpartum depression in the label; this is not a statement about mild illness. Efficacy in a trial is not a prediction for one person. An erratum exists for the SKYLARK paper and was not read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (8)

    1. Supports FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Paragraph 4, sentence 1
      How it applies
      FDA statement of efficacy in two trials.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    2. Supports FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Paragraph 4, sentence 4
      How it applies
      Primary endpoint of both studies.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    3. Supports FDA approves first oral treatment for postpartum depression (FDA press announcement)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-04

      Locator
      Paragraph 4, sentence 5
      How it applies
      FDA statement of the result.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad
      Reuse basis
      FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The page bytes are not committed. Short quotations with attribution.

    4. Supports ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13. · SPL set id: f18e53b0-d0bb-422d-8de7-ab64b7292b29

      Locator
      results[0].clinical_studies[0], sentence 1
      How it applies
      The label ties Study 1 to NCT04442503.
      Retrieved
      Source effective date
      2026-06-15
      Source state
      Current
      Snapshot hash
      f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.

    5. Supports ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13. · SPL set id: f18e53b0-d0bb-422d-8de7-ab64b7292b29

      Locator
      results[0].dosage_and_administration[0], 2.1
      How it applies
      Recommended dose in the current label.
      Retrieved
      Source effective date
      2026-06-15
      Source state
      Current
      Snapshot hash
      f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.

    6. Supports Zuranolone for the Treatment of Postpartum Depression

      Publication · The American journal of psychiatry · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists a published erratum for this paper (PMID 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected. · Published 2023-09-01 · DOI: 10.1176/appi.ajp.20220785 · PMID: 37491938

      Locator
      Abstract, RESULTS, sentence 2, fragment 2 of 3
      How it applies
      SKYLARK numbers from the abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    7. Background ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

      Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13. · SPL set id: f18e53b0-d0bb-422d-8de7-ab64b7292b29

      Locator
      results[0].clinical_studies[0], sentence 3
      How it applies
      Study 2 used a different formulation.
      Retrieved
      Source effective date
      2026-06-15
      Source state
      Current
      Snapshot hash
      f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mj-openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29.json.

    8. Background Correction to Deligiannidis et al

      Publication · The American journal of psychiatry · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. This is a published erratum (a correction notice). PubMed holds no abstract for it; only its bibliographic record was read. · Published 2025-03-01 · DOI: 10.1176/appi.ajp.20220785correction · PMID: 39659161

      Locator
      PublicationType
      How it applies
      PubMed lists a published erratum for the SKYLARK paper (PMID 39659161). It was not read.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      7f4a25189d34399d741dc149248c7d6967002b6a87356a099568b41ae8b38ad0
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Authorization

Regulatory decision: Zurzuvae (zuranolone)

Applies to Maternal
  • Adults with postpartum depression, as the label words the indication. FDA describes the supporting trials as enrolling women who met DSM criteria for a major depressive episode with onset of symptoms in the third trimester or within four weeks of delivery.
  • Prescription medicine taken by mouth (openFDA marketing status Prescription).
  • United States (FDA)
  • Postpartum
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory context)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
NDA
Submission
NDA217369
Jurisdictions
United States; note: United States
Product version
ZURZUVAE (zuranolone) capsules, NDA217369
Indication
Treatment of postpartum depression (PPD) in adults, as the current label words the indication.
Basis
FDA approved Zurzuvae (zuranolone) capsules under NDA217369 on 4 August 2023, for the treatment of postpartum depression (PPD) in adults. FDA described it as the first oral medication indicated to treat PPD in adults; before it, FDA said, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities. The current label gives a recommended dose of 50 mg by mouth once a day in the evening for 14 days and carries a boxed warning about impaired ability to drive and engage in other potentially hazardous activities.

Limitations. An approval is an FDA decision about a product. It is not an FDA recommendation to use the medicine for any person, and this record does not describe who should or should not take it. FDA's 2023 press announcement says approval was granted to Sage Therapeutics, Inc., and openFDA now lists the application sponsor as BIOGEN; the atlas does not trace the change. Label wording comes from today's label text in openFDA (label effective 2026-06-15), not from the 2023 label. openFDA says its data is unvalidated.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Record details

Record id
maternal:zurzuvae
Content hash
4424dd16a318edd4164d465f689ef958280d89dc642bf75279ee3a7888369ca4