# Zuranolone

Drug · id `maternal:zuranolone` · 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 Zurzuvae, a capsule for postpartum depression. It is a neuroactive steroid that acts on GABA-A receptors in the brain, as brexanolone does.

## Technical summary

A positive allosteric modulator of synaptic and extrasynaptic GABA-A receptors and a neuroactive steroid (SKYLARK abstract). NIMH says it acts on similar brain receptors to brexanolone. RxNorm concept 2669905 (ingredient); FDA UNII 7ZW49N180B (openFDA drugsfda record). The approved product is Zurzuvae. The SKYLARK trial tested 50 mg a day for 14 days in severe postpartum depression (see the claims on this page). The recipient is the adult postpartum woman. Fetal harm is a labelled concern (FDA press announcement of 2023); no fetal or newborn outcome claim is recorded here.

## Claims, with the population each applies to

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

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

### In SKYLARK, a double-blind phase 3 trial, 196 women with severe postpartum depression were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days (98 in each group), and 170 (86.7%) completed the 45-day study. At day 15, the primary endpoint, the average change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) total score was -15.6 with zuranolone and -11.6 with placebo, a least-squares mean difference of -4.0 (95% CI -6.3 to -1.7). The authors report significant improvement at days 3, 28 and 45 too.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Maternal; Population: Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.; Care setting: Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.; Geography: United States, Spain and United Kingdom (registry locations); Life stage: Postpartum. The abstract and the registry fields read give no postnatal age limits.; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: 45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).
- Limitations: Only the PubMed abstract was read, not the full paper. PubMed lists an erratum for the paper (PMID 39659161) that has no abstract and was not read, so these numbers are as printed in the abstract and may have been corrected. The registry names an industry lead sponsor (Biogen). The trial enrolled women with severe postpartum depression, so the result does not apply to milder illness. A rating-scale change at day 15 is not remission or relapse, and follow-up ended at day 45. The registry records 200 enrolled while the abstract prints 196 randomized; both counts are kept on the study page.
- Last checked: 2026-10-14
- Source problem: a cited source is corrected. Check the sources before relying on this claim.
- Sources:
  1. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, METHODS, sentence 1, fragment 1 of 2. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Design, randomization and dose.
  2. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, RESULTS, sentence 1. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Numbers randomized and completing the study.
  3. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, METHODS, sentence 2, fragment 1 of 3. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Primary endpoint and its timing.
  4. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, RESULTS, sentence 2, fragment 1 of 3. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Statistically significant improvement at day 15.
  5. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, RESULTS, sentence 2, fragment 2 of 3. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Mean changes and the difference with its interval.
  6. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, RESULTS, sentence 2, fragment 3 of 3. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Improvement also reported at days 3, 28 and 45.
  7. Background: A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD) (Registry, edition ClinicalTrials.gov API v2 record, last update posted 2023-11-30. The record holds a results section; the atlas does not copy registry result tables.) <https://clinicaltrials.gov/study/NCT04442503>
     Locator: protocolSection.sponsorCollaboratorsModule.leadSponsor.name. Retrieved 2026-10-14T18:18:23Z. Source state: Current. Snapshot hash: fdd893c7dccd1ed53eea5282f35f5e206c6ec2da60ddc2338db12152aff132dd.
     How it applies: Registry lead sponsor.
  8. Background: Correction to Deligiannidis et al (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.) <https://doi.org/10.1176/appi.ajp.20220785correction>
     Locator: PublicationType. Retrieved 2026-10-14T18:19:05Z. Source state: Current. Snapshot hash: 7f4a25189d34399d741dc149248c7d6967002b6a87356a099568b41ae8b38ad0.
     How it applies: PubMed lists a published erratum for this paper (PMID 39659161). It has no abstract and was not read.

### In SKYLARK the most common adverse events (10% or more) with zuranolone were somnolence, dizziness and sedation. The abstract reports no loss of consciousness, no withdrawal symptoms and no increased suicidal ideation or behavior in the trial. The US label for Zurzuvae carries a boxed warning that it causes driving impairment, and FDA says it may cause fetal harm.

- Category: Safety
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Maternal; Population: Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.; Care setting: Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.; Geography: United States, Spain and United Kingdom (registry locations); Life stage: Postpartum. The abstract and the registry fields read give no postnatal age limits.; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: 45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).
- Limitations: The abstract gives no adverse event counts, and the trial was small (196 randomized) and short (45 days), so rare harms cannot be excluded. The label statements come from today's label text in openFDA, not from the trial. Only the abstract was read, and an erratum exists that was not read.
- Last checked: 2026-10-14
- Source problem: a cited source is corrected. Check the sources before relying on this claim.
- Sources:
  1. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, RESULTS, sentence 4. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Most common adverse events in the trial.
  2. Supports: Zuranolone for the Treatment of Postpartum Depression (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 39659161). PubMed holds no abstract for the erratum, and its text was not read, so any figure taken from this abstract is stated as printed in the abstract and may have been corrected.) <https://doi.org/10.1176/appi.ajp.20220785>
     Locator: Abstract, RESULTS, sentence 5. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35.
     How it applies: Events the abstract reports as not observed.
  3. Background: ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29) (Label, edition openFDA drug label record, label effective 20260615, dataset last updated 2026-10-13.) <https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f18e53b0-d0bb-422d-8de7-ab64b7292b29>
     Locator: results\[0\].boxed\_warning\[0\]. Retrieved 2026-10-14T18:20:51Z. Source state: Current. Snapshot hash: f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869.
     How it applies: Boxed warning in the current label.
  4. Background: FDA approves first oral treatment for postpartum depression (FDA press announcement) (Regulator, edition Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023.) <https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression>
     Locator: Paragraph 6, sentence 3. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad.
     How it applies: FDA press statement at approval.
  5. Background: Correction to Deligiannidis et al (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.) <https://doi.org/10.1176/appi.ajp.20220785correction>
     Locator: PublicationType. Retrieved 2026-10-14T18:19:05Z. Source state: Current. Snapshot hash: 7f4a25189d34399d741dc149248c7d6967002b6a87356a099568b41ae8b38ad0.
     How it applies: PubMed lists a published erratum for the SKYLARK paper (PMID 39659161). It was not read.

## Connected pages

- SKYLARK: HAM-D change at day 15, zuranolone 50 mg against placebo, severe postpartum depression: Postpartum depression (mother) (`maternal:postpartum-depression`) [a claim, not a settled fact; see claim `maternal:claim-zuranolone-skylark-hamd-day-15` and its context]
- Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`)
- Contained in: Zurzuvae (zuranolone) (`maternal:zurzuvae`)
- Investigated in: SKYLARK trial (zuranolone in severe postpartum depression) (`maternal:skylark-trial`)

## Provenance

Content hash: 208e7c08f7c15177e410e3c32e55ab198d52dd7c7c17cb7a9c065c6a0211d382
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14