• Home
  • Store
    • Newsletter Subscriptions
    • Multimedia
    • Books
    • eBooks
    • ABPN SA Courses
    • Social Work Courses
  • CME Center
  • Multimedia
    • Podcast
    • Webinars
    • Blog
    • Psychiatry News Videos
    • Medication Guide Videos
  • Newsletters
    • General Psychiatry
    • Child Psychiatry
    • Addiction Treatment
    • Hospital Psychiatry
    • Geriatric Psychiatry
    • Psychotherapy and Social Work
  • FAQs
  • Med Fact Book App
  • Log In
  • Register
  • Welcome
  • Sign Out
  • Subscribe
Home » Oral Zuranolone for Postpartum Depression

Oral Zuranolone for Postpartum Depression

March 4, 2022
Michael Posternak, MD.
From The Carlat Psychiatry Report
Issue Links: Learning Objectives | Editorial Information | PDF of Issue
Michael Posternak, MD. Dr. Posternak has disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.

REVIEW OF: Deligiannidis KM et al, JAMA Psychiatry 2021;78(9):951–959


STUDY TYPE: Randomized controlled trial


DSM-5 defines postpartum depression (PPD) as any major depressive episode that begins during pregnancy or within four weeks after giving birth. Traditional antidepressants have long been used during this period, but only small studies supporting their efficacy exist and none have received FDA approval for this use. Brexanolone (Zulresso) is a neuroactive steroid that was approved by the FDA for PPD in 2019. However, this steroid requires 60 hours of continuous intravenous infusion as well as around-the-clock monitoring due to concerns for potential serious adverse effects such as loss of consciousness.


Zuranolone is an investigational medicine that is structurally similar to brexanolone but can be given orally. Both drugs work on the gabaergic system in a way that is distinct from benzodiazepines, and both are structural analogs of allopregnanolone (just as levothyroxine is a synthetic analog of the naturally occurring hormone thyroxine). This was a Phase 3 study testing the safety and efficacy of zuranolone for PPD.


In this trial, 151 women who developed new-onset depression either during their third trimester of pregnancy or within four weeks after giving birth were enrolled. Patients were randomized to receive either zuranolone 30 mg or placebo over the course of two weeks. The primary outcome measure was improvement on the Hamilton Depression Rating Scale, and assessments were made on days three, six, nine, 15, and 45.


On day 15, which was the primary date of interest, depression scores were significantly lower in the zuranolone cohort compared to placebo (-17.8 points vs -13.6 points; p = 0.003; effect size 0.53). Statistically significant effects were apparent as early as day three and were maintained through day 45, which was a full four weeks after treatment had been completed. Significant improvements were also seen in anxiety and global functioning, as well as maternal functioning. Zuranolone was well tolerated with the most common side effects being somnolence (15%), headaches (9%), and dizziness (8%), although none of these rates differed much from placebo.


The major limitation of this study is that breastfeeding women were not included, so zuranolone cannot yet be recommended for these patients. Furthermore, it remains to be seen whether the benefits of zuranolone are sustained beyond four weeks post-treatment.


TCPR’S TAKE
Zuranolone appears to be a safe and effective option for PPD. Encouragingly, its benefits appear to occur rapidly, and a two-week course of treatment may be all that is needed. The manufacturer plans to file for FDA approval in 2022. If it comes to market, it will offer a much more pragmatic option than brexanolone.

General Psychiatry
KEYWORDS depression postpartum-depression randomized-controlled-trial steroids womens-issues-in-psychiatry
    Michael Posternak, MD.

    Psychological Benefits of Abstaining from Social Media

    More from this author
    www.thecarlatreport.com
    Issue Date: March 4, 2022
    SUBSCRIBE NOW
    Table Of Contents
    CME Post-Test - Living With Mental Illness, TCPR, March 2022
    Mental Illness and Flourishing
    How to Prescribe Omega-3 Fatty Acids
    A Prescription App for Insomnia
    Vitamin B6 Lowers Prolactin on Antipsychotics
    Oral Zuranolone for Postpartum Depression
    A Longer Acting Lorazepam
    DOWNLOAD NOW
    Featured Book
    • MFB7e_Print_App_Access.png

      Medication Fact Book for Psychiatric Practice, Seventh Edition (2024) - Regular Bound Book

      The updated 2024 reference guide covering the most commonly prescribed medications in psychiatry.
      READ MORE
    Featured Video
    • KarXT (Cobenfy)_ The Breakthrough Antipsychotic That Could Change Everything.jpg
      General Psychiatry

      KarXT (Cobenfy): The Breakthrough Antipsychotic That Could Change Everything

      Read More
    Featured Podcast
    • shutterstock_2622607431.jpg
      General Psychiatry

      Should You Test MTHFR?

      MTHFR is a...
      Listen now
    Recommended
    • Join Our Writing Team

      July 18, 2024
      WriteForUs.png
    • Insights About a Rare Transmissible Form of Alzheimer's Disease

      February 9, 2024
      shutterstock_2417738561_PeopleImages.com_Yuri A.png
    • How to Fulfill the DEA's One Time, 8-Hour Training Requirement for Registered Practitioners

      May 24, 2024
      DEA_Checkbox.png
    • Join Our Writing Team

      July 18, 2024
      WriteForUs.png
    • Insights About a Rare Transmissible Form of Alzheimer's Disease

      February 9, 2024
      shutterstock_2417738561_PeopleImages.com_Yuri A.png
    • How to Fulfill the DEA's One Time, 8-Hour Training Requirement for Registered Practitioners

      May 24, 2024
      DEA_Checkbox.png
    • Join Our Writing Team

      July 18, 2024
      WriteForUs.png
    • Insights About a Rare Transmissible Form of Alzheimer's Disease

      February 9, 2024
      shutterstock_2417738561_PeopleImages.com_Yuri A.png
    • How to Fulfill the DEA's One Time, 8-Hour Training Requirement for Registered Practitioners

      May 24, 2024
      DEA_Checkbox.png

    About

    • About Us
    • CME Center
    • FAQ
    • Contact Us

    Shop Online

    • Newsletters
    • Multimedia Subscriptions
    • Books
    • eBooks
    • ABPN Self-Assessment Courses

    Newsletters

    • The Carlat Psychiatry Report
    • The Carlat Child Psychiatry Report
    • The Carlat Addiction Treatment Report
    • The Carlat Hospital Psychiatry Report
    • The Carlat Geriatric Psychiatry Report
    • The Carlat Psychotherapy Report

    Contact

    carlat@thecarlatreport.com

    866-348-9279

    PO Box 626, Newburyport MA 01950

    Follow Us

    Please see our Terms and Conditions, Privacy Policy, Subscription Agreement, Use of Cookies, and Hardware/Software Requirements to view our website.

    © 2025 Carlat Publishing, LLC and Affiliates, All Rights Reserved.