Maternal & Newborn Atlas
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Zulresso (brexanolone injection)

A medicine given as a continuous drip into a vein over 60 hours, with a health care provider on site, to treat postpartum depression. FDA approved it in 2019 for adults, and a 2022 label update extended the labelled use to patients 15 years and older. The 2019 label has a boxed warning for excessive sedation and sudden loss of consciousness. openFDA now lists it as discontinued.

  • Product
  • In this atlas

Overview

Technical summary

US NDA211371. The approval letter was signed on 2019-03-19 and defines the date of approval as the date of the DEA scheduling notice, which openFDA gives as 2019-06-17; the atlas records the decision on 2019-06-17 and keeps both dates. Brexanolone injection 100 mg per 20 mL (5 mg/mL) solution for intravenous use (openFDA drugsfda). The 2019 label, which FDA marks as possibly not the latest approved, describes a 60-hour infusion with titration to a target of 90 µg/kg per hour and names Studies 1 and 2 as NCT02942004 and NCT02942017. openFDA lists the marketing status as Discontinued and gives no date or reason. The recipient is the postpartum woman: adults in the 2019 label and patients 15 years and older in the 2022 label.

Product details

Type
Medicine
Model or formulation
Brexanolone injection, 100 mg per 20 mL (5 mg/mL) solution, for continuous intravenous infusion (openFDA drugsfda product list for NDA211371)
Version
As approved under NDA211371 (approval date 2019-06-17 under the approval letter's rule; letter signed 2019-03-19). Label text is the 2019 label. openFDA lists the product as Discontinued.

Intended-use sources

  1. Background ZULRESSO (brexanolone) injection prescribing information, 2019 label

    Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
    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 PDF bytes are not committed. Short quotations with attribution.

  2. Background ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7)

    Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The label PDF of efficacy supplement 7 (openFDA status date 2022-06-16), revised 6/2022, linked from the openFDA drugsfda record. Read for the indication only. Later supplements (REMS and others in openFDA) were not read.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    e189b37ee1442ff370eae7861ed844559478f620aa54d0c360ca78f8611071ed
    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 PDF bytes are not committed. Short quotations with attribution.

  3. Background NDA 211371 approval letter for Zulresso (brexanolone) injection

    Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7
    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 PDF bytes are not committed. Short quotations with attribution.

Claims and evidence

Context Adults with postpartum depression (2019 labelled use of Zulresso, United States)

Recipient
Maternal
Population
Adults with postpartum depression, as the 2019 label words the indication. The label describes a 60-hour continuous intravenous infusion given with a healthcare provider on site.
Care setting
Healthcare setting with continuous monitoring (2019 label, dosage and administration).
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 Zulresso (brexanolone) injection under NDA211371. The 2019 label words the indication as the treatment of postpartum depression in adults. A 2022 efficacy supplement (supplement 7, status date 2022-06-16 in openFDA) changed the labelled use to patients 15 years and older. The approval letter was signed on 19 March 2019; it says that because scheduling under the Controlled Substances Act was not yet complete, the date of approval is the date the DEA publishes its scheduling notice, and openFDA gives that date as 17 June 2019. The label describes a continuous intravenous infusion over a total of 60 hours. openFDA lists the product as discontinued.

    Applies to Maternal
    • Adults with postpartum depression, as the 2019 label words the indication. The label describes a 60-hour continuous intravenous infusion given with a healthcare provider on site.
    • Healthcare setting with continuous monitoring (2019 label, dosage and administration).
    • 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, not a recommendation to use it for any person. The atlas treats 17 June 2019 as the decision date because the letter defines the date of approval that way; openFDA also lists an original-submission action date of 19 March 2019 (the letter's signature date). openFDA gives no date or reason for the discontinuation, so none is stated here. The label read is the 2019 label, which FDA marks as possibly not the latest approved; later supplements exist in openFDA and were not read. openFDA says its data is unvalidated.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (15)

    1. Supports openFDA drugsfda record for NDA211371

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application_number found the record. The product is listed with marketing status Discontinued. · NDA: NDA211371

      Locator
      results[0].submissions[3].submission_public_notes
      How it applies
      Date of approval in openFDA (Federal Register scheduling notice).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52
      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-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.

    2. Supports NDA 211371 approval letter for Zulresso (brexanolone) injection

      Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.

      Locator
      Controlled substance scheduling, paragraph 1
      How it applies
      The letter defines the approval date by the DEA notice.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7
      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 PDF bytes are not committed. Short quotations with attribution.

    3. Supports NDA 211371 approval letter for Zulresso (brexanolone) injection

      Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.

      Locator
      Paragraph 3
      How it applies
      What the application provides for.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7
      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 PDF bytes are not committed. Short quotations with attribution.

    4. Supports NDA 211371 approval letter for Zulresso (brexanolone) injection

      Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition The approval letter PDF linked from the openFDA drugsfda record, signed electronically on 03/19/2019.

      Locator
      Signature page
      How it applies
      Signature date of the approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      8e094bbd1b952ab29b175d8adad75b109f8eed667d9575bb6b3124c9a9f1a9b7
      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 PDF bytes are not committed. Short quotations with attribution.

    5. Supports openFDA drugsfda record for NDA211371

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application_number found the record. The product is listed with marketing status Discontinued. · NDA: NDA211371

      Locator
      results[0].submissions[3].submission_status_date
      How it applies
      Original submission action date in openFDA.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52
      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-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.

    6. Supports openFDA drugsfda record for NDA211371

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application_number found the record. The product is listed with marketing status Discontinued. · NDA: NDA211371

      Locator
      results[0].application_number
      How it applies
      Application number in openFDA.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52
      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-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.

    7. Supports openFDA drugsfda record for NDA211371

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application_number found the record. The product is listed with marketing status Discontinued. · NDA: NDA211371

      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
      a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52
      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-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.

    8. Supports openFDA drugsfda record for NDA211371

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application_number found the record. The product is listed with marketing status Discontinued. · NDA: NDA211371

      Locator
      results[0].products[0].active_ingredients[0].name
      How it applies
      Active ingredient in openFDA.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52
      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-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.

    9. Supports openFDA drugsfda record for NDA211371

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application_number found the record. The product is listed with marketing status Discontinued. · NDA: NDA211371

      Locator
      results[0].products[0].marketing_status
      How it applies
      Marketing status in openFDA.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52
      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-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.

    10. Supports ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Section 1, Indications and usage
      How it applies
      Indication in the 2019 label.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    11. Supports ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Section 2.2, Recommended dosage
      How it applies
      Infusion described in the 2019 label.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    12. Background ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Page footer
      How it applies
      FDA note on the label page.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    13. Supports ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7)

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The label PDF of efficacy supplement 7 (openFDA status date 2022-06-16), revised 6/2022, linked from the openFDA drugsfda record. Read for the indication only. Later supplements (REMS and others in openFDA) were not read.

      Locator
      Section 1, Indications and usage
      How it applies
      The 2022 label wording of the indication.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e189b37ee1442ff370eae7861ed844559478f620aa54d0c360ca78f8611071ed
      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 PDF bytes are not committed. Short quotations with attribution.

    14. Supports openFDA drugsfda record for NDA211371

      Regulator · U.S. Food and Drug Administration (openFDA drugsfda endpoint) · Edition openFDA drugsfda endpoint record for NDA211371 (brand ZULRESSO), dataset last updated 2026-10-13, fetched on 2026-10-14. A first search by openfda.application_number returned HTTP 404 with no match (fetch-log label mj-openfda-drugsfda-NDA211371.json) because the discontinued product has no openfda block; the search by application_number found the record. The product is listed with marketing status Discontinued. · NDA: NDA211371

      Locator
      results[0].submissions[8].submission_status_date
      How it applies
      Status date of supplement 7 in openFDA.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      a1cbd0d0ab5fbcfd954a567730342ff3d726c615c82e5eaf7f7e6e687341be52
      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-NDA211371-b.json. openFDA says its data is unvalidated and not for medical decisions.

    15. Background ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7)

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The label PDF of efficacy supplement 7 (openFDA status date 2022-06-16), revised 6/2022, linked from the openFDA drugsfda record. Read for the indication only. Later supplements (REMS and others in openFDA) were not read.

      Locator
      Highlights, last line
      How it applies
      Revision date of the 2022 label.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e189b37ee1442ff370eae7861ed844559478f620aa54d0c360ca78f8611071ed
      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 PDF bytes are not committed. Short quotations with attribution.

Context Women aged 18 to 45 years, up to 6 months post partum, with moderate to severe postpartum depression, 60-hour infusion (2018 trials)

Recipient
Maternal
Population
Women with postpartum depression and a qualifying 17-item Hamilton Rating Scale for Depression (HAM-D) score: 26 or more in study 1 (severe) and 20 to 25 in study 2 (moderate). They received a single 60-hour intravenous infusion of brexanolone or matching placebo.
Care setting
30 clinical research centres and specialised psychiatric units (abstract).
Geography
United States
Life stage
Up to 6 months post partum at screening, aged 18 to 45 years.
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Followed until day 30; primary endpoint at 60 hours (abstract).
Eligibility: 3 inclusion criteria; 4 exclusion criteria
Included
  • Aged 18 to 45 years
  • 6 months post partum or less at screening
  • Postpartum depression with a qualifying HAM-D score (26 or more for study 1; 20 to 25 for study 2)
Excluded
  • Renal failure requiring dialysis
  • Anaemia
  • Known allergy to allopregnanolone or to progesterone
  • Medical history of schizophrenia, bipolar disorder or schizoaffective disorder

  • Effect Interventional Certainty not assessed

    FDA's 2019 label for Zulresso, which words the indication as adults, says its efficacy in postpartum depression was shown in two multicenter, randomized, double-blind, placebo-controlled studies in women aged 18 to 45, where a 60-hour continuous intravenous infusion or placebo was followed by 4 weeks of follow-up. Study 1 (NCT02942004) included severe postpartum depression and Study 2 (NCT02942017) moderate postpartum depression. In both, the label says titration to a target dose of 90 µg/kg per hour was superior to placebo in improvement of depressive symptoms. The published abstract of these two trials reports average HAM-D falls at 60 hours of 17.7 and 14.6 points with the 90 µg/kg dose against 14.0 and 12.1 with placebo.

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

    Applies to Maternal
    • Women with postpartum depression and a qualifying 17-item Hamilton Rating Scale for Depression (HAM-D) score: 26 or more in study 1 (severe) and 20 to 25 in study 2 (moderate). They received a single 60-hour intravenous infusion of brexanolone or matching placebo.
    • 30 clinical research centres and specialised psychiatric units (abstract).
    • United States
    • Up to 6 months post partum at screening, aged 18 to 45 years.
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Followed until day 30; primary endpoint at 60 hours (abstract).
    Certainty method
    Not assessed
    Limitations
    This claim rests on the 2019 label, which FDA marks as possibly not the latest approved, and on the abstract of the Lancet paper, which has an erratum that was not read. The label states p values but this record uses only the label's qualitative statement. openFDA lists Zulresso as discontinued; this claim describes trial efficacy, not current availability. Efficacy in a trial is not a prediction for one person.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (11)

    1. Supports ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Section 1, Indications and usage
      How it applies
      Labelled indication.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    2. Supports ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Section 14, Clinical studies, paragraph 1
      How it applies
      The label ties Study 1 to NCT02942004.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    3. Supports ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Section 14, Clinical studies, paragraph 3
      How it applies
      The label statement of efficacy.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    4. Supports Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials

      Publication · Lancet (London, England) · 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 30303081). 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 2018-09-22 · DOI: 10.1016/S0140-6736(18)31551-4 · PMID: 30177236

      Locator
      Abstract, FINDINGS, sentence 3, fragment 1 of 4
      How it applies
      Published numbers, study 1.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5
      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.

    5. Supports Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials

      Publication · Lancet (London, England) · 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 30303081). 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 2018-09-22 · DOI: 10.1016/S0140-6736(18)31551-4 · PMID: 30177236

      Locator
      Abstract, FINDINGS, sentence 3, fragment 2 of 4
      How it applies
      Published numbers, study 1, continued.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5
      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.

    6. Supports Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials

      Publication · Lancet (London, England) · 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 30303081). 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 2018-09-22 · DOI: 10.1016/S0140-6736(18)31551-4 · PMID: 30177236

      Locator
      Abstract, FINDINGS, sentence 4, fragment 1 of 2
      How it applies
      Published numbers, study 2.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5
      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. Supports Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials

      Publication · Lancet (London, England) · 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 30303081). 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 2018-09-22 · DOI: 10.1016/S0140-6736(18)31551-4 · PMID: 30177236

      Locator
      Abstract, FINDINGS, sentence 4, fragment 2 of 2
      How it applies
      Published numbers, study 2, continued.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5
      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.

    8. Background ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7)

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The label PDF of efficacy supplement 7 (openFDA status date 2022-06-16), revised 6/2022, linked from the openFDA drugsfda record. Read for the indication only. Later supplements (REMS and others in openFDA) were not read.

      Locator
      Section 1, Indications and usage
      How it applies
      The 2022 label widens the labelled use to patients 15 years and older.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e189b37ee1442ff370eae7861ed844559478f620aa54d0c360ca78f8611071ed
      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 PDF bytes are not committed. Short quotations with attribution.

    9. Background ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Section 2.2, Recommended dosage
      How it applies
      Dosing described in the label.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    10. Background ZULRESSO (brexanolone) injection prescribing information, 2019 label

      Label · U.S. Food and Drug Administration (Drugs@FDA) · Edition The 2019 label PDF linked from the openFDA drugsfda record (reference ID 4405779). Each page carries the note that this label may not be the latest approved by FDA. The label was read for its indication, dosing and clinical studies sections only.

      Locator
      Page footer
      How it applies
      FDA note on the label page.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4
      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 PDF bytes are not committed. Short quotations with attribution.

    11. Background Department of Error

      Publication · Lancet (London, England) · 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 2018-09-29 · DOI: 10.1016/S0140-6736(18)32288-8 · PMID: 30303081

      Locator
      PublicationType
      How it applies
      PubMed lists a published erratum for the Lancet paper (PMID 30303081). It was not read.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      f9ce582c029e3bf4f17f8b46958e775934edf799758e47e97f7306dd24e0bd16
      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: Zulresso (brexanolone injection)

Applies to Maternal
  • Adults with postpartum depression, as the 2019 label words the indication. The label describes a 60-hour continuous intravenous infusion given with a healthcare provider on site.
  • Healthcare setting with continuous monitoring (2019 label, dosage and administration).
  • 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
NDA211371
Jurisdictions
United States; note: United States. The approval letter was signed on 2019-03-19; it sets the date of approval as the date of the DEA scheduling notice, which openFDA gives as June 17, 2019.
Product version
ZULRESSO (brexanolone) injection 5 mg/mL, NDA211371
Indication
Treatment of postpartum depression (PPD) in adults, as the 2019 label words the indication.
Basis
FDA approved Zulresso (brexanolone) injection under NDA211371. The 2019 label words the indication as the treatment of postpartum depression in adults. A 2022 efficacy supplement (supplement 7, status date 2022-06-16 in openFDA) changed the labelled use to patients 15 years and older. The approval letter was signed on 19 March 2019; it says that because scheduling under the Controlled Substances Act was not yet complete, the date of approval is the date the DEA publishes its scheduling notice, and openFDA gives that date as 17 June 2019. The label describes a continuous intravenous infusion over a total of 60 hours. openFDA lists the product as discontinued.

Limitations. An approval is an FDA decision about a product, not a recommendation to use it for any person. The atlas treats 17 June 2019 as the decision date because the letter defines the date of approval that way; openFDA also lists an original-submission action date of 19 March 2019 (the letter's signature date). openFDA gives no date or reason for the discontinuation, so none is stated here. The label read is the 2019 label, which FDA marks as possibly not the latest approved; later supplements exist in openFDA and were not read. 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:zulresso
Content hash
3d8e0753cf62aedde9c8480324af6e20c7e7f040ee5d7de929d9e54273770fc8