On March 14, 2025, the United States Food and Drug Administration (FDA) announced that the manufacturer of brexanolone (Zulresso®), Sage Therapeutics, had notified the FDA that it was no longer marketing brexanolone (Zulresso®). Accordingly, the FDA withdrew approval of brexanolone (Zulresso®), effective April 14, 2025. The manufacturer stated elsewhere that the withdrawal of brexanolone (Zulresso®) was for commercial reasons.
Brexanolone (U.S. brand name Zulresso®) is a neuroactive steroid and a gamma-aminobutyric acid (GABA) A receptor positive modulator that was available as an injection for intravenous use. It has to be given as a continuous intravenous infusion over 60 hours, that is, 2.5 days. It was approved by the FDA in March 2019.
On this page, we present basic information about this medication. Other articles on this website with more advanced information and tips related to this medication are linked under Related Pages below.
FDA-approved indications
Treatment of postpartum depression in adults.
Note that brexanolone is the first medication that has been approved by the FDA specifically for the treatment of postpartum depression.
How well does it work?
What is so special about brexanolone? Not that it is more effective than other antidepressants, but that it works very quickly–in just a couple of days–so that, if it works, the mother could potentially be back quickly to be with her baby with less or no depression. For our review of the efficacy of brexanolone, please see the following article on this website (for subscribers only):
How well does brexanolone (brand name Zulresso) work?
REMS program
Brexanolone carries a Boxed Warning and has to be prescribed through a special Risk Evaluation and Mitigation Strategy (REMS) program. What this means is that it is only available at healthcare facilities that have been specifically certified through the brexanolone REMS program, and the patient’s information has to be registered with the REMS program before the treatment is given.
Why? Why is a special REMS program needed? Because there is a concern that excessive sedation or sudden loss of consciousness can occur while the intravenous injection of brexanolone is being given. Because of this risk, patients have to be carefully monitored during the infusion, and continuous pulse oximetry monitoring has to be done (which is easy to do, of course). Also, while the infusion is being given, the mother has to be supervised while interacting with her children.
Potential side effects
Other than possible sedation and loss of consciousness, other side effects reported with brexanolone were dry mouth and flushing.
Dosage
Brexanolone is administered as a continuous intravenous infusion over 60 hours (about 2.5 days) as follows (source: Prescribing Information):
- 0 to 4 hours: Initiate with a dosage of 30 mcg/kg/hour
- 4 to 24 hours: Increase dosage to 60 mcg/kg/hour
- 24 to 52 hours: Increase dosage to 90 mcg/kg/hour (alternatively, consider a dosage of 60 mcg/kg/hour for those who do not tolerate 90 mcg/kg/hour)
- 52 to 56 hours: Decrease dosage to 60 mcg/kg/hour
- 56 to 60 hours: Decrease dosage to 30 mcg/kg/hour
Administration instructions
The medication needs to be diluted in preparation for the infusion.
Several precautions need to be taken to make sure the correct dose is given and the patient is appropriately monitored:
1. A programmable peristaltic infusion pump should be used because it ensures more accurate delivery of the correct dose of the medication being infused.
2. No other medications should be mixed into the infusion bag being used for brexanolone or given through the same intravenous line.
3. The patient must be carefully monitored throughout the infusion by a member of the medical team because of the risk of sedation.
4. Continuous pulse oximetry monitoring has to be done throughout the infusion.
5. While the infusion is being given, the mother has to be supervised while interacting with her children.
Dosage forms and strengths
Injection: 100 mg/20 mL (5 mg/mL) single-dose vial.
Important! Please refer to the full Prescribing Information (see link below) before prescribing this medication.
Related Pages
Zuranolone (Zurzuvae™): Key facts
References
Prescribing information for brexanolone (Zulresso®)
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