# Brexanolone Drug · id `maternal:brexanolone` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Postpartum Browse, care area: Mental health ## In plain language The active substance in Zulresso, a medicine given by drip into a vein over about 2.5 days in hospital to treat postpartum depression. It is a neuroactive steroid that acts on GABA-A receptors in the brain, as zuranolone does. ## Technical summary Brexanolone injection (formerly SAGE-547) is a positive allosteric modulator of GABA-A receptors (Lancet abstract). RxNorm concept 2121777 (ingredient). The approved product is Zulresso (NDA211371), now listed as discontinued in openFDA. Two phase 3 trials of a 60-hour infusion in moderate and severe postpartum depression are recorded on this atlas (see the claims on this page). The recipient is the adult postpartum woman. ## Claims, with the population each applies to ## 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). ### Two double-blind, placebo-controlled phase 3 trials of a single 60-hour intravenous infusion of brexanolone in postpartum depression randomized 138 women in study 1 (brexanolone 90 µg/kg per hour n=45, 60 µg/kg per hour n=47, placebo n=46) and 108 in study 2 (brexanolone 90 µg/kg per hour n=54, placebo n=54). In study 1, severe depression, the average fall in HAM-D total score at 60 hours was 19.5 points with the 60 µg/kg dose, 17.7 with the 90 µg/kg dose and 14.0 with placebo, differences from placebo of -5.5 (95% CI -8.8 to -2.2, p=0.0013) and -3.7 (95% CI -6.9 to -0.5, p=0.0252). In study 2, moderate depression, the fall was 14.6 points with the 90 µg/kg dose and 12.1 with placebo, a difference of -2.5 (95% CI -4.5 to -0.5, p=0.0160). - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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). - Limitations: Only the PubMed abstract was read. PubMed lists an erratum (PMID 30303081) that has no abstract and was not read, so these numbers are as printed in the abstract. The trials were funded by Sage Therapeutics (abstract funding line). Follow-up ended at day 30, the primary endpoint was a rating-scale change at the end of the infusion, and the trials excluded women with a history of schizophrenia, bipolar disorder or schizoaffective disorder. Study 2 tested one active dose, and study 1 also tested a lower dose. The abstract does not say which of these doses the marketed product uses; see the FDA label for dosing. - Last checked: 2026-10-14 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Trial design and setting. 2. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 2, fragment 1 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Numbers randomized, study 1. 3. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 2, fragment 2 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Numbers randomized, study 2. 4. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 3, fragment 1 of 4. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Study 1 mean reductions. 5. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 3, fragment 2 of 4. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Study 1 mean reductions, continued. 6. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 3, fragment 3 of 4. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Study 1 differences and intervals. 7. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 3, fragment 4 of 4. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Study 1 p value for the 90 µg/kg dose. 8. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 4, fragment 1 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Study 2 mean reductions. 9. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 4, fragment 2 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Study 2 difference and interval. 10. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, METHODS, sentence 6, fragment 1 of 3. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Primary endpoint at 60 hours. 11. Background: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FUNDING, sentence 1. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Funder named in the abstract. 12. Background: Department of Error (Publication, 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.) Locator: PublicationType. Retrieved 2026-10-14T18:19:05Z. Source state: Current. Snapshot hash: f9ce582c029e3bf4f17f8b46958e775934edf799758e47e97f7306dd24e0bd16. How it applies: PubMed lists a published erratum for this paper (PMID 30303081). It has no abstract and was not read. ### In study 1, adverse events occurred in 19 women given the 60 µg/kg dose, 22 given the 90 µg/kg dose and 22 given placebo; in study 2, in 25 given the 90 µg/kg dose and 24 given placebo. One woman in the 60 µg/kg group of study 1 had two serious adverse events, suicidal ideation and an intentional overdose attempt during follow-up. One woman in the 90 µg/kg group of study 2 had two serious adverse events, altered state of consciousness and syncope, which were considered treatment related. The 2019 US label for Zulresso carries a boxed warning for excessive sedation and sudden loss of consciousness. - Category: Safety - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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). - Limitations: Only the PubMed abstract was read, and an erratum exists that was not read. The abstract lists events by group counts only, and the trials were small, so rare harms cannot be excluded. The boxed warning is from the 2019 label, which FDA marks as possibly not the latest approved. - Last checked: 2026-10-14 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 5, fragment 1 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Adverse event counts, study 1. 2. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 5, fragment 2 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Adverse event counts, study 1, continued. 3. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 6. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Adverse event counts, study 2. 4. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 8. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Serious adverse events, study 1. 5. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 9, fragment 1 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Serious adverse events, study 2. 6. Supports: Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials (Publication, 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.) Locator: Abstract, FINDINGS, sentence 9, fragment 2 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 6da149ef575c6e6c0df7e98de4de6e2279a52a96331d993fb643d21420407bb5. How it applies: Serious adverse events, study 2, continued. 7. Background: ZULRESSO (brexanolone) injection prescribing information, 2019 label (Label, 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: Boxed warning. Retrieved 2026-10-14T18:26:35Z. Source state: Current. Snapshot hash: ae65819167e75f88419dc1b7d0c8c896345d165eb98eb36b377b6ce1e41031e4. How it applies: Boxed warning on the 2019 label. 8. Background: Department of Error (Publication, 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.) Locator: PublicationType. Retrieved 2026-10-14T18:19:05Z. Source state: Current. Snapshot hash: f9ce582c029e3bf4f17f8b46958e775934edf799758e47e97f7306dd24e0bd16. How it applies: PubMed lists a published erratum for this paper (PMID 30303081). It was not read. ## Connected pages - Two phase 3 trials: HAM-D change at 60 hours, brexanolone against placebo: Postpartum depression (mother) (`maternal:postpartum-depression`) [a claim, not a settled fact; see claim `maternal:claim-brexanolone-trials-hamd-60-hours` and its context] - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) - Contained in: Zulresso (brexanolone injection) (`maternal:zulresso`) - Investigated in: Brexanolone phase 3 trials (studies 202B and 202C) (`maternal:hummingbird-brexanolone-trials`) ## Provenance Content hash: a4f14509e2a299b3aa5dc15797b0422fc2c66b1762aca83503ea166da9c5e11b Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14