Frieder A, Fersh M, Hainline R, et al. Pharmacotherapy of postpartum depression: current approaches and novel drug development. CNS Drugs. 2019;33(3):265–82.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Rubin R. A fast-acting pill received approval for postpartum depression—is it a game changer? JAMA. 2023. https://doi.org/10.1001/jama.2023.16499.

Article  PubMed  Google Scholar 

Gunduz-Bruce H, Takahashi K, Huang MY. Development of neuroactive steroids for the treatment of postpartum depression. J Neuroendocrinol. 2022;34(e13019):1–10.

Google Scholar 

US Food & Drug Administration. FDA approves first oral treatment for postpartum depression [media release]. 4 Aug 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression.

Sage Therapeutics. FDA approves ZURZUVAE™ (zuranolone), the first and only oral treatment approved for women with postpartum depression, and issues a complete response letter for major depressive disorder [media release]. 4 Aug 2023. https://investor.sagerx.com/news-releases/news-release-details/fda-approves-zurzuvaetm-zuranolone-first-and-only-oral-treatment.

Sage Therapeutics. ZURZUVAETM (zuranolone) US prescribing information. 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217369s000lbl.pdf. Accessed 5 Sep 2023.

Bullock A, Kaul I, Li S, et al. Zuranolone as an oral adjunct to treatment of Parkinsonian tremor: a phase 2, open-label study. J Neurol Sci. 2021;421(117277):1–5.

Google Scholar 

Paskavitz J, Bullock A, Nguyen D, et al. GABA-A receptor positive allosteric modulators: phase 2 proof of concept studies of brexanolone injection and SAGE-217 in essential tremor [abstract] Movement disorder. 2019;34:S73.

Google Scholar 

ClinicalTrials.gov. A study to evaluate SAGE-217 in subjects with bipolar I/II disorder with a current major depressive episode - part A. 2018. https://www.cochranelibrary.com/central/doi/10.1002/central/CN-01706518/full. Accessed 4 Sep 2023.

Sage Therapeutics. Sage Therapeutics announces clinical updates and progress across neuroscience pipeline during Sage FutureCast [media release]. 24 Jul 2019. http://www.sagerx.com.

Biogen, Sage T. Biogen and Sage Therapeutics announce global collaboration to develop and commercialize potential breakthrough therapies in depression and movement disorders [media release]. 27 Nov 2020. http://www.biogen.com.

Sage Therapeutics., Shionogi C. Sage Therapeutics and Shionogi Co., Ltd., enter strategic collaboration to develop and commercialize SAGE-217 for MDD and other indications in Japan, Taiwan and South Korea [media release]. 15 Jun 2018. http://www.sagerx.com.

United States securities and exchange commission. Form 10-K. Sage Therapeutics, Inc. . 2021. https://www.sec.gov/ix?doc=/Archives/edgar/data/1597553/000156459022006495/sage-10k_20211231.htm. Accessed 31 Aug 2023.

Althaus AL, Ackley MA, Belfort GM, et al. Preclinical characterization of zuranolone (SAGE-217), a selective neuroactive steroid GABAA receptor positive allosteric modulator. Neuropharmacology. 2020;181(108333):1–10.

Google Scholar 

Dunbar J, Lasser R, Rana N, et al. Abuse potential of zuranolone in nondependent, recreational users of central nervous system depressants: a randomized, double-blind, active- and placebo-controlled crossover study [abstract no. S36 plus poster]. In: The College on Problems of Drug Dependence (CPDD) annual meeting. 2022.

Srinivas N, Jung J, Dunbar J. Zuranolone, a novel GABAA positive allosteric modulator, does not prolong the QT interval [abstract no. PII-093 and poster]. Clin Pharmacol Ther. 2023;113:S72–3.

Google Scholar 

Deligiannidis KM, Meltzer-Brody S, Maximos B, et al. Zuranolone for the treatment of postpartum depression. Am J Psychiatry. 2023:1-8.

Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, et al. Effect of zuranolone vs placebo in postpartum depression: a randomized clinical trial. JAMA Psychiat. 2021;78(9):951–9.

Article  Google Scholar 

Maximos B, Deligiannidis K, Meltzer-Brody S, et al. Effect of zuranolone on insomnia symptoms in patients with postpartum depression in the SKYLARK study [abstract no. 408 plus poster]. Am J Obstet Gynecol. 2023;228(1 Suppl):S272.

Deligiannidis KM, Citrome L, Huang MY, et al. Effect of zuranolone on concurrent anxiety and insomnia symptoms in women with postpartum depression. J Clin Psychiatry. 2023;84(1).

Deligiannidis K, Huang MY, Suthoff E, et al. Evaluation of insomnia symptoms in a double-blind, randomized, placebo-controlled phase 3 trial of zuranolone in postpartum depression [abstract plus presentation]. Biol Psychiatry. 2021;89(9):S91.

Gunduz-Bruce H, Silber C, Kaul I, et al. Trial of SAGE-217 in patients with major depressive disorder. N Engl J Med. 2019;381(10):903–11.

Article  CAS  PubMed  Google Scholar 

Clayton AH, Lasser R, Parikh SV, et al. Zuranolone for the treatment of adults with major depressive disorder: a randomized, placebo-controlled phase 3 trial. Am J Psychiatry. 2023:1-9.

Clayton AH, Lasser R, Nandy I, et al. Zuranolone in major depressive disorder: results from MOUNTAIN-a phase 3, multicenter, double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2023;84(2):1–11.

Article  Google Scholar 

Parikh SV, Aaronson S, Mathew SJ, et al. Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3, randomized, double-blind, placebo-controlled CORAL study [abstract, poster plus oral presentation]. American Society of Clinical Psychopharmacology (ASCP) annual meeting. 2022;Abstract Book:40-1.

Cutler A, Aaronson S, Mattingly G, et al. Zuranolone 30 mg in major depressive disorder: results through 1-year follow-up from the phase 3, open-label, SHORELINE study [abstract no. P.0672 plus poster]. Eur Neuropsychopharmacol. 2021;53(Suppl 1):S492‐S3.

Cutler A, Aaronson S, Mattingly G, et al. Safety, tolerability, and efficacy of zuranolone repeat treatment courses in adult patients with major depressive disorder–an analysis of the open-label, phase 3 SHORELINE study [abstract plus poster]. In: Psych Congress annual meeting (Psych). 2022.

Mattingly G, Czysz A, Vera T, et al. Safety and efficacy of zuranolone repeat treatment using PHQ-9 depression severity in patients with major depressive disorder from the SHORELINE study [abstract no. W27 plus poster]. In: American Society of Clinical Psychopharmacology Annual Meeting (ASCP). 2023.

Brown R, DelBello M, Strakowski S, et al. Safety and efficacy of zuranolone in young adults with major depressive disorder: a subgroup analysis of the open-label, long-term, phase 3 SHORELINE study [abstract plus poster]. In: Psych Congress Annual Meeting (Psych) 2022.

Cutler A, Aaronson ST, Mattingly GW, et al. Zuranolone in the treatment of major depressive disorder in patients ≥ 65 years of age: outcomes from the phase 3, naturalistic SHORELINE study [abstract no. P271 plus poster T88]. Neuropsychopharmacology. 2021;46(Suppl 1):143-4.

Mattingly G, Aaronson S, Lasser R, et al. Zuranolone safety and efficacy in patients with major depressive disorder (MDD) and metabolic comorbidities: results From the Phase 3 SHORELINE Study [abstract no. W47 plus poster]. In: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, May 31-June 3, 2022 Scottsdale, AZ. 2022.

Suthoff E, Kosinski M, Arnaud A, et al. Patient-reported health-related quality of life from a randomized, placebo-controlled phase 2 trial of zuranolone in adults with major depressive disorder. J Affect Disord. 2022;308:19–26.

Article  CAS  PubMed  Google Scholar 

Czysz A, Nemeroff C, Schatzberg A, et al. Improvement in depressive symptoms with zuranolone treatment in patients with major depressive disorder with or without elevated anxiety: pooled analysis from the MDD- 201B, MOUNTAIN, and WATERFALL studies [abstract no. P242 plus poster #W77]. Neuropsychopharmacology. 2022;47:201–2.

Google Scholar 

Kato M, Nakagome K, Baba T, et al. Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: a double-blind, randomized, placebo-controlled, phase 2 clinical trial. Psychiatry Clin Neurosci. 2023;77(9):497–509.

Article  CAS  PubMed  Google Scholar 

Clayton A, Deligiannidis K, Vera T, et al. Rapid antidepressant effects of zuranolone in patients with major depressive disorder and postpartum depression: overview of the LANDSCAPE and NEST clinical development programs [abstract plus poster]. In: American Association of Psychiatric Pharmacists (AAPP) annual meeting. 2023.

Clayton A, Cutler A, Deligiannidis K, et al. Summary of early (day 2/3) and primary (day 15) clinical efficacy outcomes from the ongoing clinical development program for zuranolone in the treatment of major depressive disorder and postpartum depression [abstract plus presentation]. In: 11th International Meeting Steroids and Nervous System (S&NS) virtual meeting. 2022.

US National Institutes of Health. ClinicalTrials.gov identifer NCT05655507. 2023. http://clinicaltrials.gov/. Accessed 22 Sep 2023.