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Zuranolone, sold under the brand name Zurzuvae, is a medication used for the treatment of postpartum depression. It is taken by mouth. Zuranolone is a neuroactive steroid which enhances the activity of the neurotransmitter gamma-aminobutyric acid (GABA) and is thought to exert antidepressant effects by enhancing GABAergic inhibition.
The most common include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
Zuranolone was approved for medical use in the United States for the treatment of postpartum depression in August 2023. It was developed by Sage Therapeutics and Biogen.
The US prescribing information contains a boxed warning noting that zuranolone can impact a person's ability to drive and perform other potentially hazardous activities. The use of zuranolone may cause suicidal thoughts and behavior. Zuranolone may also cause fetal harm.
The efficacy of zuranolone for the treatment of postpartum depression in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. The trial participants were women with postpartum depression who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery. In study 1, participants received 50 mg of zuranolone or placebo once daily in the evening for 14 days. In study 2, participants received another zuranolone product that was approximately equal to 40 mg of zuranolone or placebo, also for 14 days. Participants in both studies were monitored for at least four weeks after the 14-day treatment. The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15. Participants in the zuranolone groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at day 42—four weeks after the last dose of zuranolone.
In the United States, zuranolone is a Schedule IV controlled substance.
In July 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zurzuvae, intended for the treatment of adults with postpartum depression. The applicant for this medicinal product is Biogen Netherlands B.V. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Zuranolone was authorized for medical use in the European Union in September 2025.
Zuranolone is sold under the brand name Zuranolone.
Other investigational applications include insomnia, bipolar depression, essential tremor, and Parkinson's disease.
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