Prescription medicine
Zuranolone Brand names: Zurzuvae
Zuranolone (Zurzuvae) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the zuranolone FDA label on DailyMed (effective June 15, 2026, Biogen MA Inc.); the NDA 217369 record on Drugs@FDA; every zuranolone label on DailyMed.
Highlights of the record
FDA label of June 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 ).
Used for
From the label: indications and usageZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults.
Forms and strengths
- 20 mg
- 25 mg
- 30 mg
Capsule.
On the market
- Earliest approval on file
- August 4, 2023 Zurzuvae, Biogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 23, 2037 Zurzuvae capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,579 through July 30, 2026
What is zuranolone used for?
From the label: indications and usageZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults.
Conditions named in the indications of zuranolone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator.
Source: FDA drug label (ZURZUVAE), Biogen MA Inc., effective June 15, 2026 (SPL set f18e53b0-d0bb-422d-8de7-ab64b7292b29), via openFDA; the full label on DailyMed
What does the patient leaflet for zuranolone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZURZUVAE?ZURZUVAE can cause serious side effects, including: Decreased ability to drive or do other dangerous activities. ZURZUVAE can decrease your awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities. Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose during your 14-day treatment course of ZURZUVAE. You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you. Decreased awareness and alertness [central nervous system (CNS) depressant effects]. ZURZUVAE can cause sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking. Because of these symptoms, you may be at a higher risk for falls during treatment with ZURZUVAE. Taking alcohol, other medicines that cause CNS depressant effects, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing. Tell your healthcare provider if you develop any of these symptoms, or if they get worse during treatment with ZURZUVAE. Your healthcare provider may decrease your dose or stop ZURZUVAE treatment if you develop these symptoms. See " What are the possible side effects of ZURZUVAE? " for more information about side effects.
From the patient leaflet: What should I avoid while taking ZURZUVAE?Do not drive a car, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose of ZURZUVAE because ZURZUVAE may make you feel sleepy, confused, or dizzy. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking ZURZUVAE without talking to your healthcare provider. See “ What is the most important information I should know about ZURZUVAE? ”
From the patient leaflet: How should I store ZURZUVAE?Store ZURZUVAE at room temperature between 68°F to 77°F (20°C to 25°C). Keep ZURZUVAE and all medicines out of the reach of children.
Source: FDA drug label (ZURZUVAE), Biogen MA Inc., effective June 15, 2026 (SPL set f18e53b0-d0bb-422d-8de7-ab64b7292b29), via openFDA; the full label on DailyMed
Is there a generic for zuranolone (Zurzuvae)?
No generic zuranolone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Zurzuvae capsules: the compound patent runs to August 23, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for zuranolone?
The FDA Adverse Event Reporting System holds 1,579 reports that list zuranolone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 70 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as zuranolone?
30 other medicines are given the same way (oral) and in the same FDA class as zuranolone or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
| Venlafaxine | Depression | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
| Aripiprazole | Depression | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Fluoxetine | Depression | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Duloxetine | Depression | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Doxepin | Depression | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
Every medicine labeled for the same conditions as zuranolone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to zuranolone
- 30 medicines for the same use
- Other neuroactive steroid gamma-aminobutyric acid a receptor positive modulators
- the pharmacologic class, with prices and generics
- Zuranolone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other