Last reviewed 2026-04-20 · How we verify

Zurzuvae (ZURANOLONE)

Zurzuvae works by binding to the GABA A receptor, enhancing the inhibitory effects of GABA to calm overactive neurons.

Zurzuvae (Zuranolone) is a small molecule modality developed by SAGE THERAP and currently owned by Biogen Inc. It targets the GABA A receptor alpha-4/beta-3/delta subunit, which is involved in regulating neuronal excitability. Approved by the FDA in 2023, Zurzuvae is indicated for the treatment of postpartum depression. As a patented medication with no generic manufacturers, its commercial status is proprietary. Key safety considerations are not publicly available.

At a glance

Mechanism of action

Imagine your brain is like a busy city with lots of people talking and moving around. GABA is like a calming police officer that helps keep the peace by telling people to quiet down and slow down. Zurzuvae helps GABA do its job more effectively, which can help reduce symptoms of postpartum depression.

Approved indications

• Postpartum Depression

Boxed warnings

• WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE [see Warnings and Precautions ( 5.1 )] . WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES See full prescribing information for complete boxed warning. ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects. Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after administration. Patients may not be able to assess their own driving competence or the degree of impairment caused by ZURZUVAE ( 5.1 , 5.2 ) .

Common side effects

• Somnolence
• Dizziness
• Diarrhea
• Fatigue
• Urinary tract infection
• Memory impairment
• Abdominal pain
• Tremor
• Hypoesthesia
• Muscle twitching
• Myalgia
• COVID-19

Serious adverse events

• Confusional state

Drug interactions

• CNS Depressant Drugs and Alcohol
• Strong CYP3A4 Inhibitors
• CYP3A4 Inducers

Key clinical trials

• A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
• Allopregnanolone (Zuranolone) in Post-stroke Depression (PHASE2)
• A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy
• Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD) (PHASE1)
• A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD) (PHASE3)
• A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD) (PHASE3)
• A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder (PHASE3)
• A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression (PHASE3)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Zurzuvae CI brief — competitive landscape report
• Zurzuvae updates RSS · CI watch RSS
• Biogen portfolio CI