Zulresso Approval History
Reviewed by J.Stewart BPharm. Last updated on Mar 27, 2019.
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 History and FDA Approval Process for Zulresso
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