Brexanolone

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.

Drug
In this atlas

Overview

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.

About this drug

Level: Substance
Mechanism: Positive allosteric modulator of gamma-aminobutyric-acid type A (GABA-A) receptors, as described in the Lancet abstract.

Claims and evidence

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

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).

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
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

Next evidence check due
Not scheduled
Sources and citations (12)
1. 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, METHODS, sentence 1
  
  How it applies
  Trial design and setting.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
2. 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 2, fragment 1 of 2
  
  How it applies
  Numbers randomized, study 1.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
3. 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 2, fragment 2 of 2
  
  How it applies
  Numbers randomized, study 2.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
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
  Study 1 mean reductions.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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
  Study 1 mean reductions, continued.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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 3, fragment 3 of 4
  
  How it applies
  Study 1 differences and intervals.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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 3, fragment 4 of 4
  
  How it applies
  Study 1 p value for the 90 µg/kg dose.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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. 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
  Study 2 mean reductions.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
9. 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
  Study 2 difference and interval.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
10. 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, METHODS, sentence 6, fragment 1 of 3
  
  How it applies
  Primary endpoint at 60 hours.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
11. Background 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, FUNDING, sentence 1
  
  How it applies
  Funder named in the abstract.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
12. 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 this paper (PMID 30303081). It has no abstract and was not read.
  
  Retrieved
  2026-10-14T18:19:05Z
  
  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.
Safety Interventional Certainty not assessed

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.

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
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

Next evidence check due
Not scheduled
Sources and citations (8)
1. 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 5, fragment 1 of 2
  
  How it applies
  Adverse event counts, study 1.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
2. 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 5, fragment 2 of 2
  
  How it applies
  Adverse event counts, study 1, continued.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
3. 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 6
  
  How it applies
  Adverse event counts, study 2.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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.
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 8
  
  How it applies
  Serious adverse events, study 1.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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 9, fragment 1 of 2
  
  How it applies
  Serious adverse events, study 2.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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 9, fragment 2 of 2
  
  How it applies
  Serious adverse events, study 2, continued.
  
  Retrieved
  2026-10-14T18:18:20Z
  
  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. 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
  Boxed warning
  
  How it applies
  Boxed warning on the 2019 label.
  
  Retrieved
  2026-10-14T18:26:35Z
  
  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.
8. 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 this paper (PMID 30303081). It was not read.
  
  Retrieved
  2026-10-14T18:19:05Z
  
  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.

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.

Claim, not a settled fact Two phase 3 trials: HAM-D change at 60 hours, brexanolone against placebo: Postpartum depression (mother) (Claimed to treat)
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).
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).
Source problem. A cited source is corrected. Check the sources before relying on this claim.
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.

Record details

Record id: maternal:brexanolone
Content hash: a4f14509e2a299b3aa5dc15797b0422fc2c66b1762aca83503ea166da9c5e11b