Short answer: Zuranolone (Zurzuvae) is the first pill approved specifically for postpartum depression, taken once a day for 14 days. It is a Schedule IV controlled substance. It carries a boxed warning: people must not drive or do other dangerous activities for at least 12 hours after each dose.
Key takeaways
- What it is: Zuranolone is a neuroactive steroid (gaba-a receptor modulator) and a Schedule IV controlled substance in the US.
- Main uses: Postpartum depression.
- Timing: effects start in improvement often within days and last 14-day course.
- Most dangerous mix: Alcohol, opioids, benzodiazepines, sleep medicines, which can cause profound sedation, loss of consciousness.
- Naloxone: it does not reverse this drug, but give it whenever opioids could be involved.
- Dependence risk: Low to moderate.
- Legal route: only with a prescription from a DEA-registered clinician, filled by a licensed pharmacy.
What is zuranolone?
Zuranolone treats postpartum depression, which affects about 1 in 7 people after giving birth. In trials, symptoms improved within 3 to 15 days, faster than typical antidepressants.
It is related to brexanolone (Zulresso), an earlier postpartum depression treatment given as a 60-hour intravenous infusion.
Quick facts
| Fact | Zuranolone |
|---|---|
| Generic name | Zuranolone |
| Brand names | Zurzuvae |
| Drug class | Neuroactive steroid; positive allosteric modulator of GABA-A receptors |
| US legal status | Schedule IV, prescription only (since 2023) |
| Approved uses | Postpartum depression in adults |
| Forms | Capsules (20, 25, 30 mg) |
| Course | Once daily in the evening for 14 days |
| Half-life | About 20 to 25 hours |
How long does zuranolone last?
- Starts working: Improvement often within days
- Effects last: 14-day course
- Half-life: About 20 to 25 hours
Timing varies with the dose, the form, how it is taken, liver and kidney function, age, and other drugs taken at the same time.
What are the biggest risks of zuranolone?
The FDA requires boxed warnings, its strongest, on zuranolone products, including:
- Impaired ability to drive or do other dangerous activities: zuranolone causes drowsiness and slowed thinking. Do not drive or operate machinery for at least 12 hours after each dose. People may not be able to judge their own impairment.
- Suicidal thoughts and behaviors: as with other antidepressants, there is a risk in children and young adults.
Common side effects include sleepiness, dizziness, diarrhea, tiredness, and urinary tract infection.
CNS depression: with alcohol, opioids, or other sedatives it can cause deep sedation, confusion, and loss of consciousness.
Pregnancy: it may harm a fetus; effective contraception is advised during treatment and for 1 week after.
What should you never mix with zuranolone?
| Combined with | What happens | Label guidance |
|---|---|---|
| Alcohol, opioids, benzodiazepines, sleep medicines | Profound sedation, loss of consciousness | Avoid or use caution |
| Strong CYP3A4 inhibitors (ketoconazole, clarithromycin) | Higher levels | Reduce dose to 30 mg |
| CYP3A4 inducers (rifampin, carbamazepine) | Lower levels and effect | Avoid |
Check any combination with the DoseUses combination checker or ask a pharmacist.
What are the signs of a zuranolone overdose, and what should you do?
Overdose is expected to cause excessive sleepiness, confusion, and loss of consciousness, especially with other depressants.
If someone may have overdosed
- Call 911 if the person is unresponsive, hard to wake, or breathing slowly.
- For advice when the person is awake and stable, call Poison Help at 1-800-222-1222 (US, free, 24 hours).
- If opioids could be involved, including pills not from a pharmacy, give naloxone if you have it. Naloxone does not reverse zuranolone, but it will not harm the person.
- Stay with the person and place them on their side if they are drowsy or vomiting.
Does zuranolone cause withdrawal?
Zuranolone is taken for only 14 days. Trials did not identify a withdrawal syndrome, but it is Schedule IV because high doses can cause sedation and euphoria similar to other sedatives.
- After the 14 daysCourse endsNo taper is needed.
- WeeksFollow-upMood should be monitored; depression can return.
- OngoingSupportTherapy, support, and other treatment may be needed.
See the withdrawal timelines and the full zuranolone withdrawal guide.
Is zuranolone legal?
In the United States, zuranolone is a Schedule IV controlled substance. The only legal way to get it is with a prescription from a clinician registered with the Drug Enforcement Administration (DEA), filled by a licensed pharmacy. Depending on state law, that can be a physician, nurse practitioner, or physician assistant.
- Refills: a Schedule IV prescription can be refilled up to five times within six months of the date it was written. After that, a new prescription is needed.
- Telehealth: federal flexibilities let DEA-registered clinicians prescribe Schedule II to V medicines after a telemedicine visit, without a prior in-person exam, through December 31, 2026. A permanent DEA rule was under final review in late 2026. State rules can be stricter.
- Monitoring: prescribers and pharmacists in most states check a prescription drug monitoring program, a database of controlled-substance prescriptions, before prescribing or dispensing.
Outside the United States
| Country | Status |
|---|---|
| International | Not under UN control |
Frequently asked questions about zuranolone
How fast does Zurzuvae work?
In trials, some people improved within 3 days, with clear benefit by day 15.
Why can't you drive on zuranolone?
It causes drowsiness and slowed thinking that can last into the next day, so driving is not allowed for at least 12 hours after each dose.
Can you breastfeed while taking zuranolone?
Small amounts pass into breast milk; discuss risks and benefits with the prescriber.
Is Zurzuvae an antidepressant?
Yes, but it works differently from SSRIs, by enhancing GABA-A receptors.
Is zuranolone a controlled substance?
Yes, Schedule IV.
Sources
- Zurzuvae (zuranolone) prescription information, DailyMed, US National Library of Medicine.
- Controlled Substance Schedules, DEA Diversion Control Division.
- 21 CFR 1306.22, Refilling of prescriptions (Schedules III and IV), Electronic Code of Federal Regulations.
- Prescribing controlled substances via telehealth, US Department of Health and Human Services.
- BeSafeRx: Your Source for Online Pharmacy Information, US Food and Drug Administration.
- Safe Pharmacy, National Association of Boards of Pharmacy.
- One Pill Can Kill, US Drug Enforcement Administration.
- International drug control conventions, United Nations Office on Drugs and Crime.
This guide summarizes the sourced DoseUses Zuranolone profile, written from FDA labels, DEA rules, and federal health agencies. It is educational and is not medical advice. Last updated October 5, 2026.
