Zuranolone, sold under the brand nameZurzuvae, is amedication used for the treatment ofpostpartum depression.[1] It is takenby mouth.[1] Zuranolone is a neuroactive steroid which enhances the activity of the neurotransmitter gamma-aminobutyric acid (GABA) and is thought to exert antidepressant effects by enhancing GABAergic inhibition.[3][8][9]
Zuranolone was approved for medical use in the United States for the treatment of postpartum depression in August 2023.[10] It was developed by Sage Therapeutics andBiogen.[11]
The most common side effects include drowsiness, dizziness, diarrhea, fatigue, and urinary tract infection.[10]
The USprescribing information contains aboxed warning noting that zuranolone can impact a person's ability to drive and perform other potentially hazardous activities.[10] The use of zuranolone may cause suicidal thoughts and behavior.[10] Zuranolone may also cause fetal harm.[10]
Zuranolone was developed as an improvement on the intravenously administered neurosteroidbrexanolone, with high oralbioavailability and abiological half-life suitable for once-daily administration.[8][12] Its half-life is around 16 to 23hours, compared to approximately 9hours for brexanolone.[6][7]
The efficacy of zuranolone for the treatment of postpartum depression in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies.[10] The trial participants were women with postpartum depression who met theDiagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery.[10] In study 1, participants received 50 mg of zuranolone or placebo once daily in the evening for 14 days.[10] In study 2, participants received another zuranolone product that was approximately equal to 40 mg of zuranolone or placebo, also for 14 days.[10] Participants in both studies were monitored for at least four weeks after the 14-day treatment.[10] The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15.[10] Participants in the zuranolone groups showed significantly more improvement in their symptoms compared to those in the placebo groups.[10] The treatment effect was maintained at day 42—four weeks after the last dose of zuranolone.[10]
Zuranolone was approved by the USFood and Drug Administration (FDA) for the treatment of postpartum depression in August 2023.[10][13] The FDA granted the application for zuranolonepriority review andfast track designations.[10] Approval of Zurzuvae was granted to Sage Therapeutics, Inc.[10] Zuranolone has also been under development for the treatment ofmajor depressive disorder, but the application for this use was given aComplete Response Letter by the FDA due to insufficient evidence of effectiveness.[14]
In July 2025, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zurzuvae, intended for the treatment of adults with postpartum depression.[3] The applicant for this medicinal product is Biogen Netherlands B.V.[3] Zuranolone was authorized for medical use in the European Union in September 2025.[3][4]
In a randomized, placebo-controlledphase III trial to assess its efficacy and safety for the treatment ofmajor depressive disorder, subjects in the zuranolone group (50 mg oral zuranolone once daily for 14 days) experienced statistically significant and sustained improvements in depressive symptoms (as measured byHAM-D score) throughout the treatment and follow-up periods of the study.[16]
^abcde"Zurzuvae EPAR".European Medicines Agency (EMA). 25 July 2025. Retrieved27 July 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ab"Zurzuvae PI".Union Register of medicinal products. 18 September 2025. Retrieved30 September 2025.
^abBlanco MJ, La D, Coughlin Q, Newman CA, Griffin AM, Harrison BL, et al. (2018). "Breakthroughs in neuroactive steroid drug discovery".Bioorganic & Medicinal Chemistry Letters.28 (2):61–70.doi:10.1016/j.bmcl.2017.11.043.PMID29223589.
^Martinez Botella G, Salituro FG, Harrison BL, Beresis RT, Bai Z, Blanco MJ, et al. (2017). "Neuroactive Steroids. 2. 3α-Hydroxy-3β-methyl-21-(4-cyano-1H-pyrazol-1'-yl)-19-nor-5β-pregnan-20-one (SAGE-217): A Clinical Next Generation Neuroactive Steroid Positive Allosteric Modulator of the (γ-Aminobutyric Acid)A Receptor".Journal of Medicinal Chemistry.60 (18):7810–7819.doi:10.1021/acs.jmedchem.7b00846.PMID28753313.
^World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82".WHO Drug Information.33 (3).hdl:10665/330879.
^Clayton AH, Lasser R, Parikh SV, Iosifescu DV, Jung J, Kotecha M, et al. (May 2023). "Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo-Controlled Phase 3 Trial".The American Journal of Psychiatry.180 (9):676–684.doi:10.1176/appi.ajp.20220459.PMID37132201.S2CID258461851.
Clinical trial numberNCT04442503 for "A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)" atClinicalTrials.gov
Clinical trial numberNCT02978326 for "A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression" atClinicalTrials.gov
This article incorporates text from this source, which is in thepublic domain.