# Zurzuvae (zuranolone) Product · id `maternal:zurzuvae` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (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 A capsule taken by mouth once a day in the evening for 14 days to treat postpartum depression in adults. FDA approved it in August 2023 and described it as the first oral medicine for postpartum depression. The label has a boxed warning that it can impair the ability to drive and to do other potentially hazardous activities, and FDA says it may cause fetal harm. ## Technical summary US NDA217369, approved 2023-08-04 (FDA press announcement and openFDA drugsfda). Capsules of 20 mg, 25 mg and 30 mg (openFDA product list). The current label (effective 2026-06-15, read through openFDA) gives 50 mg by mouth once daily in the evening with fat-containing food for 14 days, with a lower dose if central nervous system depressant effects occur, alone or as an adjunct to oral antidepressant therapy. The label names SKYLARK (NCT04442503) as Study 1 of two efficacy studies. The 2023 press announcement says approval was granted to Sage Therapeutics, Inc.; openFDA now lists BIOGEN as sponsor. This page records what FDA authorised and what the trials found; it is not advice about use. The recipient is the adult postpartum woman. ## Claims, with the population each applies to ## Context: Adults with postpartum depression (labelled use of Zurzuvae, United States) Recipient: Maternal; Population: Adults with postpartum depression, as the label words the indication. FDA describes the supporting trials as enrolling women who met DSM criteria for a major depressive episode with onset of symptoms in the third trimester or within four weeks of delivery.; Care setting: Prescription medicine taken by mouth (openFDA marketing status Prescription).; Geography: United States (FDA); Life stage: Postpartum; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### FDA approved Zurzuvae (zuranolone) capsules under NDA217369 on 4 August 2023, for the treatment of postpartum depression (PPD) in adults. FDA described it as the first oral medication indicated to treat PPD in adults; before it, FDA said, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities. The current label gives a recommended dose of 50 mg by mouth once a day in the evening for 14 days and carries a boxed warning about impaired ability to drive and engage in other potentially hazardous activities. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Maternal; Population: Adults with postpartum depression, as the label words the indication. FDA describes the supporting trials as enrolling women who met DSM criteria for a major depressive episode with onset of symptoms in the third trimester or within four weeks of delivery.; Care setting: Prescription medicine taken by mouth (openFDA marketing status Prescription).; Geography: United States (FDA); Life stage: Postpartum; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Limitations: An approval is an FDA decision about a product. It is not an FDA recommendation to use the medicine for any person, and this record does not describe who should or should not take it. FDA's 2023 press announcement says approval was granted to Sage Therapeutics, Inc., and openFDA now lists the application sponsor as BIOGEN; the atlas does not trace the change. Label wording comes from today's label text in openFDA (label effective 2026-06-15), not from the 2023 label. openFDA says its data is unvalidated. - Last checked: 2026-10-14 - Sources: 1. Supports: 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.) Locator: Press announcement date line. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: Date of FDA's announcement of the approval. 2. Supports: 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.) Locator: Paragraph 1, sentence 1. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: FDA statement of the approval and indication. 3. Supports: 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.) Locator: Paragraph 1, sentence 3. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: FDA statement that treatment was only available as an IV injection until then. 4. Supports: openFDA drugsfda record for NDA217369 (Regulator, edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14.) Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:20:32Z. Source state: Current. Snapshot hash: c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a. How it applies: Application number in openFDA. 5. Supports: openFDA drugsfda record for NDA217369 (Regulator, edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14.) Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-14T18:20:32Z. Source state: Current. Snapshot hash: c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a. How it applies: Brand name in openFDA. 6. Supports: openFDA drugsfda record for NDA217369 (Regulator, edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14.) Locator: results\[0\].submissions\[1\].submission\_status\_date. Retrieved 2026-10-14T18:20:32Z. Source state: Current. Snapshot hash: c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a. How it applies: Date of the original submission action in openFDA (2023-08-04). 7. Supports: 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.) Locator: results\[0\].indications\_and\_usage\[0\]. Retrieved 2026-10-14T18:20:51Z. Source state: Current. Snapshot hash: f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869. How it applies: Indication in the current label. 8. Supports: 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.) Locator: results\[0\].dosage\_and\_administration\[0\], 2.1. Retrieved 2026-10-14T18:20:51Z. Source state: Current. Snapshot hash: f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869. How it applies: Recommended dose in the current label. 9. Supports: 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.) 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. 10. Supports: 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.) Locator: Paragraph 5, sentence 1. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: FDA press statement about the boxed warning. 11. 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.) Locator: Paragraph 8, last sentence. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: Approval holder named in 2023. 12. Background: openFDA drugsfda record for NDA217369 (Regulator, edition openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14.) Locator: results\[0\].sponsor\_name. Retrieved 2026-10-14T18:20:32Z. Source state: Current. Snapshot hash: c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a. How it applies: Sponsor listed in openFDA now. ## 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). ### FDA states that the efficacy of Zurzuvae in adults with postpartum depression was shown in two randomized, double-blind, placebo-controlled, multicenter studies. The primary endpoint was the change in HAMD-17 total score at day 15, and the Zurzuvae groups showed significantly more improvement than the placebo groups. The current label names the first of the two studies (Study 1) as NCT04442503, the SKYLARK trial, whose published abstract reports -15.6 points with zuranolone 50 mg against -11.6 with placebo (difference -4.0, 95% CI -6.3 to -1.7). The label's recommended dose is 50 mg by mouth once a day in the evening for 14 days. - 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: This claim rests on FDA's press announcement of 2023 and the current label text in openFDA, plus the SKYLARK abstract. The label's Study 2 (NCT02978326) tested another zuranolone capsule formulation, approximately equivalent to 40 mg of Zurzuvae, and is not recorded in this atlas. The label and the abstract give different participant counts for Study 1, and the atlas does not reconcile them. The press announcement gives no numbers. The population is severe postpartum depression in the SKYLARK abstract and adults with postpartum depression in the label; this is not a statement about mild illness. Efficacy in a trial is not a prediction for one person. An erratum exists for the SKYLARK paper and was not read. - Last checked: 2026-10-14 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: 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.) Locator: Paragraph 4, sentence 1. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: FDA statement of efficacy in two trials. 2. Supports: 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.) Locator: Paragraph 4, sentence 4. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: Primary endpoint of both studies. 3. Supports: 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.) Locator: Paragraph 4, sentence 5. Retrieved 2026-10-14T18:20:21Z. Source state: Current. Snapshot hash: ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad. How it applies: FDA statement of the result. 4. Supports: 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.) Locator: results\[0\].clinical\_studies\[0\], sentence 1. Retrieved 2026-10-14T18:20:51Z. Source state: Current. Snapshot hash: f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869. How it applies: The label ties Study 1 to NCT04442503. 5. Supports: 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.) Locator: results\[0\].dosage\_and\_administration\[0\], 2.1. Retrieved 2026-10-14T18:20:51Z. Source state: Current. Snapshot hash: f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869. How it applies: Recommended dose in the current label. 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.) Locator: Abstract, RESULTS, sentence 2, fragment 2 of 3. Retrieved 2026-10-14T18:18:20Z. Source state: Corrected. Snapshot hash: 12c6ed30532a24be00a480e7f5dcb6792d5416f1ad5788ee1cf27d8f2a0c0b35. How it applies: SKYLARK numbers from the abstract. 7. 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.) Locator: results\[0\].clinical\_studies\[0\], sentence 3. Retrieved 2026-10-14T18:20:51Z. Source state: Current. Snapshot hash: f3b10768b79c29b67094f1486e3cc7023e968b4ebb6dea5247b472eedc40a869. How it applies: Study 2 used a different formulation. 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.) 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. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-nda217369` - Product: Zurzuvae (zuranolone) (`maternal:zurzuvae`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2023-08-04 - Product version: ZURZUVAE (zuranolone) capsules, NDA217369 - Pathway: NDA - Submission: NDA217369 - Indication: Treatment of postpartum depression (PPD) in adults, as the current label words the indication. - Jurisdictions: United States; note: United States - Applies to: Recipient: Maternal; Population: Adults with postpartum depression, as the label words the indication. FDA describes the supporting trials as enrolling women who met DSM criteria for a major depressive episode with onset of symptoms in the third trimester or within four weeks of delivery.; Care setting: Prescription medicine taken by mouth (openFDA marketing status Prescription).; Geography: United States (FDA); Life stage: Postpartum; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-nda217369-approval` ## Connected pages - Active ingredient: Zuranolone (`maternal:zuranolone`) - FDA: efficacy shown in two placebo-controlled trials; SKYLARK numbers at day 15: Postpartum depression (mother) (`maternal:postpartum-depression`) [a claim, not a settled fact; see claim `maternal:claim-zurzuvae-ppd-efficacy` and its context] - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) - Investigated in: SKYLARK trial (zuranolone in severe postpartum depression) (`maternal:skylark-trial`) ## Provenance Content hash: 4424dd16a318edd4164d465f689ef958280d89dc642bf75279ee3a7888369ca4 Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14