{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:zurzuvae", "owner": "maternal", "kind": "product", "slug": "zurzuvae", "name": "Zurzuvae (zuranolone)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "spl-set-id", "value": "f18e53b0-d0bb-422d-8de7-ab64b7292b29", "normalized_value": "f18e53b0-d0bb-422d-8de7-ab64b7292b29", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "postpartum" ], "care-area": [ "maternal-mental-health" ] } }, "payload": { "subtype": "medicine", "model_or_formulation": "Zuranolone oral capsules, 20 mg, 25 mg and 30 mg (openFDA drugsfda product list for NDA217369)", "version": "As approved under NDA217369 on 2023-08-04. Label text is the current label effective 2026-06-15 as served by openFDA.", "intended_use_snapshots": [ "maternal:openfda-label-f18e53b0-d0bb-422d-8de7-ab64b7292b29-2026-10-14", "maternal:fda-zurzuvae-approval-press-2026-10-14" ] }, "content_digest": "4424dd16a318edd4164d465f689ef958280d89dc642bf75279ee3a7888369ca4", "review": { "content_digest": "4424dd16a318edd4164d465f689ef958280d89dc642bf75279ee3a7888369ca4", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-nda217369-approval", "owner": "maternal", "subject_entity_id": "maternal:zurzuvae", "category": "regulatory", "statement": "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.", "context": { "id": "maternal:ctx-fda-nda217369-adults-with-postpartum-depression", "label": "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_note": "Postpartum", "life_stage_terms": { "maternal": [ "postpartum" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory context)", "eligibility": { "inclusion": [ "Adults with postpartum depression" ], "exclusion": [ "Not stated in the parts of the label read for this record; see the label for contraindications and warnings" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Press announcement date line", "applicability_note": "Date of FDA's announcement of the approval.", "snapshot": { "id": "maternal:fda-zurzuvae-approval-press-2026-10-14", "retrieved_at": "2026-10-14T18:20:21Z", "content_hash": "ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad", "source_effective_date": "2023-08-22", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zurzuvae-approval-press", "source_type": "regulator", "title": "FDA approves first oral treatment for postpartum depression (FDA press announcement)", "canonical_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression", "identifiers": [], "publication_date": "2023-08-04", "publisher": "U.S. Food and Drug Administration", "edition": "Press announcement dated August 04, 2023. 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Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Paragraph 1, sentence 1", "applicability_note": "FDA statement of the approval and indication.", "snapshot": { "id": "maternal:fda-zurzuvae-approval-press-2026-10-14", "retrieved_at": "2026-10-14T18:20:21Z", "content_hash": "ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad", "source_effective_date": "2023-08-22", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zurzuvae-approval-press", "source_type": "regulator", "title": "FDA approves first oral treatment for postpartum depression (FDA press announcement)", "canonical_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression", "identifiers": [], "publication_date": "2023-08-04", "publisher": "U.S. Food and Drug Administration", "edition": "Press announcement dated August 04, 2023. The page says its content was current as of 08/22/2023.", "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 page bytes are not committed. Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Paragraph 1, sentence 3", "applicability_note": "FDA statement that treatment was only available as an IV injection until then.", "snapshot": { "id": "maternal:fda-zurzuvae-approval-press-2026-10-14", "retrieved_at": "2026-10-14T18:20:21Z", "content_hash": "ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad", "source_effective_date": "2023-08-22", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zurzuvae-approval-press", "source_type": "regulator", "title": "FDA approves first oral treatment for postpartum depression (FDA press announcement)", "canonical_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression", "identifiers": [], "publication_date": "2023-08-04", "publisher": "U.S. Food and Drug Administration", "edition": "Press announcement dated August 04, 2023. 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Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].application_number", "applicability_note": "Application number in openFDA.", "snapshot": { "id": "maternal:openfda-drugsfda-nda217369-2026-10-14", "retrieved_at": "2026-10-14T18:20:32Z", "content_hash": "c915373d8342a068cc25da4a906db94bdaa6f153396bff22c7344e98aa6b207a", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-drugsfda-nda217369", "source_type": "regulator", "title": "openFDA drugsfda record for NDA217369", "canonical_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA217369%22", "identifiers": [ { "scheme": "fda-nda", "value": "NDA217369", "normalized_value": "NDA217369", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA drugsfda endpoint)", "edition": "openFDA drugsfda endpoint record for NDA217369 (brand ZURZUVAE), dataset last updated 2026-10-13, fetched on 2026-10-14.", "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. 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Short quotations with attribution.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Paragraph 8, last sentence", "applicability_note": "Approval holder named in 2023.", "snapshot": { "id": "maternal:fda-zurzuvae-approval-press-2026-10-14", "retrieved_at": "2026-10-14T18:20:21Z", "content_hash": "ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad", "source_effective_date": "2023-08-22", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zurzuvae-approval-press", "source_type": "regulator", "title": "FDA approves first oral treatment for postpartum depression (FDA press announcement)", "canonical_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression", "identifiers": [], "publication_date": "2023-08-04", "publisher": "U.S. Food and Drug Administration", "edition": "Press announcement dated August 04, 2023. 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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.", "context": { "id": "maternal:ctx-skylark-severe-ppd-women-18-45", "label": "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_note": "Postpartum. The abstract and the registry fields read give no postnatal age limits.", "life_stage_terms": { "maternal": [ "postpartum" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).", "eligibility": { "inclusion": [ "Women aged 18 to 45 years (registry)", "Severe postpartum depression (abstract)" ], "exclusion": [ "Not stated in the parts of the abstract and registry fields that were read" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Paragraph 4, sentence 1", "applicability_note": "FDA statement of efficacy in two trials.", "snapshot": { "id": "maternal:fda-zurzuvae-approval-press-2026-10-14", "retrieved_at": "2026-10-14T18:20:21Z", "content_hash": "ed96e61675291b5318abb26ded7e0d06866745024b486e763b58e9b91ef997ad", "source_effective_date": "2023-08-22", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-zurzuvae-approval-press", "source_type": "regulator", "title": "FDA approves first oral treatment for postpartum depression (FDA press announcement)", "canonical_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression", "identifiers": [], "publication_date": "2023-08-04", "publisher": "U.S. Food and Drug Administration", "edition": "Press announcement dated August 04, 2023. 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