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Zulresso FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved March 19, 2019)
Brand name: Zulresso
Generic name: brexanolone
Dosage form: Injection
Company: Sage Therapeutics
Treatment for: Postpartum Depression

Zulresso (brexanolone) is a gamma-aminobutyric acid A (GABAA) receptor positive allosteric modulator indicated for the treatment of postpartum depression (PPD).

  • The prescribing information for Zulresso carries a Boxed Warning advising the risk of excessive sedation or loss of consciousness during administration. During this time, patients must be monitored for excessive sedation, must have continuous pulse oximetry monitoring, and must be accompanied during interactions with their child(ren).
  • Zulresso is available only through a restricted program called the Zulresso REMS.
  • Zulresso is administered as a continuous intravenous infusion over 60 hours (2.5 days). A healthcare provider must be available to continuously monitor the patient and intervene as necessary, for the duration of the infusion.
  • Zulresso can cause serious side effects including an increased risk of suicidal thoughts or actions.
  • Common adverse reactions include sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.

Development Timeline for Zulresso

Mar 19, 2019Approval  FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression
Nov 20, 2018Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection
Nov  2, 2018Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
May 30, 2018Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression
Apr 23, 2018Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
Nov  9, 2017Sage Therapeutics Announces Brexanolone Achieves Primary Endpoints in Both Phase 3 Clinical Trials in Postpartum Depression

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.