Zurzuvae (Zuranolone) for Postpartum Depression

Medically Reviewed and Fact-Checked by: Kimberly Langdon M.D., Medical Editor

Zuranolone, an innovative medication, has emerged as a potential game-changer in the treatment of postpartum depression (PPD). This guide provides an in-depth look at Zuranolone, its benefits, potential side effects, and other critical aspects for patients and their loved ones.

What Is Zurzuvae (Zuranolone)?

Zurzuvae (generic name zuranolone) is a prescription pill for postpartum depression in adults. The U.S. Food and Drug Administration (FDA) approved it on August 4, 2023, as the first oral medication specifically for postpartum depression.

It is taken once a day for just 14 days, and in clinical trials many women started to feel better within days rather than weeks. That makes it very different from standard antidepressants, which are usually taken for months and take several weeks to work.

  • Approved for: postpartum depression in adults only. The FDA did not approve zuranolone for major depression outside the postpartum period, saying the evidence was not strong enough.
  • Drug class: a neuroactive steroid that acts on GABA-A receptors in the brain, the same system targeted by the hormone allopregnanolone.
  • Controlled substance: Schedule IV, because it has some potential for misuse.
  • Boxed warning: it can impair driving. Do not drive for at least 12 hours after each dose.

How Does Zurzuvae Work?

Zuranolone boosts the activity of GABA-A receptors, which calm brain activity. After childbirth, levels of the hormone allopregnanolone, which also acts on these receptors, drop sharply, and researchers believe some women are especially sensitive to that change. The FDA label notes that exactly how zuranolone treats postpartum depression is not fully understood.

Unlike SSRIs such as Zoloft, zuranolone does not directly act on serotonin or other monoamine systems. Its half-life is about 20 to 25 hours, which supports once-daily dosing.

How Well Does Zurzuvae Work?

Two randomized, placebo-controlled trials led to approval.

SKYLARK Trial (Severe Postpartum Depression)

  • 196 women with severe postpartum depression took zuranolone 50 mg or placebo for 14 days.
  • By day 15, depression scores had dropped by an average of 15.6 points with zuranolone versus 11.6 with placebo.
  • The difference was also significant at days 3, 28 and 45, meaning improvement started early and lasted a month after treatment ended.

ROBIN Trial (Moderate to Severe Postpartum Depression)

This trial used a 30 mg formulation and reported detailed results over time:

  • Day 3: depression scores were already significantly lower than with placebo.
  • Day 15: 72% of women taking zuranolone had their symptoms cut at least in half, compared with 48% on placebo. 45% reached remission, versus 23%.
  • Day 45, a month after the last dose: 53% were in remission, compared with 30% on placebo.
  • Anxiety and day-to-day functioning as a mother also improved.

Placebo response was high in both trials, which is common in depression research, and not everyone improved. Remission rates show that zuranolone helps many women but is not a guaranteed cure.

How Long Does Zurzuvae Take to Work?

In the ROBIN trial, women taking zuranolone had significantly lower depression scores than those on placebo by day 3, and 19% were in remission by that point, compared with 5% on placebo. Many people notice changes within the first week, though the full course is 14 days and the biggest differences were measured at days 15 and 45.

For comparison, traditional antidepressants usually take 4 to 8 weeks to reach their full effect.

What Women in the Clinical Trials Experienced

Online reviews and forum posts about Zurzuvae range from “it changed everything” to “it knocked me out.” Individual stories are real, but they can’t tell you how common an experience is. The clinical trials give the most reliable picture of what to expect:

  • Most people finished the course. In SKYLARK, 86.7% of women completed the full 45-day study.
  • Sleepiness was the biggest complaint. In SKYLARK, 36% of women taking Zurzuvae reported sleepiness, compared with 6% on placebo. Dizziness and sedation were also common.
  • Side effects were often similar to placebo in the second trial. In ROBIN, 60% of women on zuranolone reported any side effect, compared with 52% on placebo. Headache was actually slightly more common with placebo.
  • Serious problems were rare. ROBIN had one serious side effect in each group: a confusional episode with zuranolone that resolved within 7 hours, and pancreatitis with placebo. SKYLARK reported no loss of consciousness and no increase in suicidal thoughts.
  • It wasn’t only mood. In ROBIN, anxiety symptoms and day-to-day functioning as a mother also improved compared with placebo.
  • Benefits outlasted the pills. Improvements were still present at day 45, a month after the last dose.
  • It didn’t work for everyone. About half of women taking zuranolone in ROBIN were not in remission at day 15.

If you’ve tried Zurzuvae and it didn’t help enough, that’s important to tell your prescriber. Other treatments, including antidepressants and therapy, remain effective options.

How to Take Zurzuvae

  • Dose: 50 mg (two 25 mg capsules) once daily in the evening for 14 days.
  • Take it with fat-containing food, such as a meal of 400 to 1,000 calories with 25% to 50% fat. Food roughly doubles how much of the drug is absorbed.
  • Missed dose: skip it and take the next dose at the usual time the following evening. Don’t double up.
  • Lower doses (40 mg or 30 mg) may be used if you have strong side effects, liver or kidney problems, or take certain other medications.
  • It can be taken alone or alongside an antidepressant you already take.
  • Use beyond 14 days has not been studied.

Zurzuvae Side Effects

The most common side effects in the SKYLARK trial were:

Side effect Zurzuvae Placebo
Sleepiness (somnolence) 36% 6%
Dizziness 13% 9%
Diarrhea 6% 2%
Fatigue 5% 2%
Memory problems 3% 0%

Across both trials, the label lists the most common side effects (5% or more, and more often than placebo) as sleepiness, dizziness, diarrhea, fatigue, cold-like symptoms and urinary tract infection.

In the SKYLARK trial, 2% of women stopped treatment because of a side effect, compared with 1% on placebo, and 16% had their dose lowered, most often for sleepiness or dizziness.
In trials, a small number of women had confusion, including one serious case that resolved within hours. There were no cases of loss of consciousness in SKYLARK, and the trial did not find an increase in suicidal thoughts.

Driving Impairment (Boxed Warning)

This is the most important safety warning:

  • A single 50 mg dose significantly impaired driving the next morning, about 9 hours later, in a driving simulator study, and impairment was still seen on day 8 of daily dosing.
  • Do not drive or do other hazardous activities for at least 12 hours after each dose.
  • You may not be able to tell that you are impaired.

Practically, that means planning your 14 days so someone else can drive, especially for early-morning school runs or appointments.

Other Warnings

  • Alcohol, benzodiazepines, opioids and other sedating drugs can make drowsiness and impaired coordination worse and increase the risk of breathing problems.
  • Falls are more likely because of drowsiness.
  • Suicidal thoughts: like all antidepressants, the label carries a warning to watch for worsening mood or suicidal thoughts. Tell your doctor right away if this happens.
  • Dependence: in a study, some people had withdrawal-like symptoms such as insomnia, palpitations, nausea and nightmares after stopping, even after about a week of dosing.
  • Misuse potential was comparable to alprazolam (Xanax) in a formal study, so extra caution is advised for anyone with a history of substance use disorder.
  • Drug interactions: strong CYP3A4 inhibitors require a lower dose, and CYP3A4 inducers should be avoided. Give your prescriber a full list of your medications.

Why Is Zurzuvae a Controlled Substance?

Zurzuvae is a Schedule IV controlled substance, the same federal category as medications like alprazolam (Xanax). Controlled substance scheduling reflects a drug’s potential for misuse and dependence. The FDA label reports:

  • Misuse potential: in a formal human abuse potential study, zuranolone had dose-dependent abuse potential comparable to alprazolam and greater than placebo.
  • Physical dependence: after 6 to 7 days of 50 mg daily doses, some people who stopped had mild to moderate withdrawal-like symptoms, including insomnia, heart palpitations, decreased appetite, nightmares, nausea, sweating and paranoia.
  • Higher risk for some people: people with a history of drug misuse or substance use disorder may be more likely to misuse it.

In the SKYLARK trial, researchers did not observe withdrawal symptoms at the end of the 14-day course, so the risk appears low when the medication is used as prescribed. Because of its Schedule IV status, Zurzuvae couldn’t be dispensed until federal scheduling took effect on October 31, 2023, about three months after FDA approval.

Does Zurzuvae Make You Feel High?

Most women in the trials didn’t report feeling high, and the most common effect was sleepiness. But in the study that deliberately tested misuse potential, done in healthy people with a history of recreational sedative use, zuranolone produced higher scores than placebo on measures including “drug liking” and “high,” and some participants reported euphoric mood and feeling drunk. Those effects were dose-dependent.

At the prescribed 50 mg evening dose, the effect most people notice is sedation, which is why the 12-hour driving rule exists.

What this means for you:

  • Take it exactly as prescribed, for the 14-day course.
  • Tell your prescriber if you have a history of substance use.
  • Store it securely and don’t share it.
  • Avoid alcohol and other sedating medications while taking it.

Can You Breastfeed While Taking Zurzuvae?

According to the FDA label and the NIH’s LactMed database:

  • Only small amounts pass into breast milk. The estimated dose a baby would receive is less than 1% of the mother’s weight-adjusted dose.
  • Levels in milk were undetectable 4 to 6 days after the last dose.
  • LactMed says zuranolone is not a reason to stop breastfeeding, but recommends watching the baby for excessive sleepiness, especially newborns and premature babies.
  • There are no data on effects in breastfed babies, and limited data on milk supply. A small drop in pumped milk volume in the study may have been due to the study’s design.

ACOG advises talking with your ob-gyn about your options and says it’s not clear how the medication affects milk production or breastfed babies. Two approaches are reasonable: you may be able to keep breastfeeding through the 14 days, or pause breastfeeding and resume a week after your last dose. Pumping and storing milk beforehand, or pumping and discarding during treatment, can make a pause easier. Talk it through with your prescriber and your baby’s pediatrician.

Zurzuvae and Pregnancy

Zurzuvae is for use after birth. Based on animal studies, it may cause fetal harm, and there are not enough human data to know the risk. In April 2026, the FDA updated the pregnancy section of the label to add results from a study in pregnant mice, which found lower fetal weight, delayed bone development and birth defects such as cleft palate at high doses, with a narrower safety margin than earlier rat studies.

Use effective birth control during treatment and for 1 week after the last dose. If you become pregnant while taking it, your provider can register you with the National Pregnancy Registry for Antidepressants at 1-844-405-6185. For medication options during pregnancy, see antidepressants during pregnancy.

How Much Does Zurzuvae Cost?

The list price at launch was about $15,900 for the 14-day course. According to the Policy Center for Maternal Mental Health, Sage Therapeutics announced that wholesale price on November 7, 2023. We could not verify a current list price, and prices change, so treat this as a starting point rather than today’s number.

Almost no one pays the list price. What you pay depends on your insurance. Insurers and pharmacy benefit managers negotiate discounts, and your share is your plan’s copay or coinsurance. Things to know:

  • Insurance: many plans cover it, but prior authorization is common for specialty drugs. Your prescriber’s office can help submit the paperwork.
  • ZURZUVAE Savings Card Program: offers financial help for eligible patients with commercial insurance. Restrictions apply.
  • ZURZUVAE For You: the manufacturer’s support program helps with insurance and treatment questions. Call 1-844-987-9882, Monday through Friday, 8 a.m. to 6 p.m. ET.

Zurzuvae was developed by Sage Therapeutics, which was later acquired by Supernus Pharmaceuticals, and is marketed with Biogen.

Will Insurance Cover It?

Most likely, but with conditions. The Policy Center for Maternal Mental Health has tracked insurer policies since the drug launched:

  • In March 2024, only 17 of more than 1,000 insurers had published coverage guidelines. Of those, five required patients to try another medication first.
  • By December 2024, nearly all insurers had published guidelines, and the Policy Center concluded that most provide reasonable access. It flagged Centene and one Kaiser plan as overly restrictive.
  • State Medicaid programs were largely covering it without undue restrictions. Four states were exceptions, and Alabama and North Carolina were the most restrictive, requiring patients to try two antidepressants first.
  • As a brand-name specialty drug, it usually sits on a higher formulary tier, which means a larger copay, and prior authorization is common.

If you’re denied or delayed: ask your prescriber’s office to file an appeal, ask the manufacturer’s support program for help, and know that the Policy Center for Maternal Mental Health has offered to support appeals for patients with moderate to severe postpartum depression who are denied coverage.

How to Get Zurzuvae Filled

Zurzuvae usually isn’t something you pick up at any neighborhood pharmacy on the same day. It’s typically dispensed through a specialty pharmacy, which is also where the manufacturer’s savings card is applied. The usual steps:

  1. Your prescriber sends the prescription, often to a specialty pharmacy that handles Zurzuvae.
  2. Your insurance reviews it. Many plans require prior authorization for specialty medications, so your prescriber’s office may need to submit paperwork first.
  3. The specialty pharmacy contacts you to confirm your cost, apply any savings card if you have commercial insurance, and arrange delivery or pickup.
  4. Plan your 14 days before you start, including evening doses with a fat-containing meal and someone else to drive for at least 12 hours after each dose.

If anything stalls, ask your prescriber’s office for an update or call ZURZUVAE For You at 1-844-987-9882.

Zurzuvae vs. SSRIs and Brexanolone

Zurzuvae SSRIs (e.g., sertraline) Brexanolone (Zulresso)
How it’s taken Pill, once daily for 14 days Pill, daily for months 60-hour IV infusion
Time to work Days in trials Usually 4 to 8 weeks Measured at end of infusion
Approved for PPD specifically Yes No (used off-label for PPD) Yes, but no longer sold in the U.S.
Main safety issue Sleepiness, no driving for 12 hours Nausea, sleep changes, sexual side effects Sudden loss of consciousness

No trial has compared zuranolone directly with SSRIs. A modeling study funded by the manufacturer estimated faster symptom improvement with zuranolone, but that is not the same as a head-to-head trial. SSRIs have far more long-term and breastfeeding safety data. Learn more about antidepressants for postpartum depression and brexanolone.

Who Can Prescribe Zurzuvae?

You don’t need a psychiatrist. Your ob-gyn, midwife or family doctor can prescribe Zurzuvae, which the Policy Center for Maternal Mental Health has called a significant change, because it means treatment doesn’t have to wait for a psychiatry referral. A psychiatrist can still be helpful, especially if you have a complex history or other medications. See how to find a perinatal psychiatrist.

The manufacturer also offers a telehealth matching service on its website that connects people with providers who can evaluate them, which may help if your own provider isn’t familiar with the medication.

Is Zurzuvae Available Outside the U.S.?

Yes, in Europe. The European Commission authorized Zurzuvae for postpartum depression in adults on September 17, 2025, following a positive opinion from the European Medicines Agency’s committee on July 24, 2025. The marketing authorization is held by Biogen Netherlands B.V., and the medicine is under additional monitoring in the EU.

Who May Not Be a Good Fit

  • People who can’t avoid driving or hazardous tasks for 12 hours after each evening dose for two weeks
  • People taking medications that strongly affect CYP3A4, or other sedating drugs
  • People with a history of substance use disorder, without close follow-up
  • People with severe kidney disease or on dialysis (not studied)
  • Anyone under 18 (not approved)
  • People who are pregnant or planning pregnancy soon

The label lists no absolute contraindications, so your prescriber will weigh these factors with you.

Getting Treatment

Zurzuvae is one option. Therapy, SSRIs and support are also effective, and many people combine approaches. If you think you have postpartum depression, take the Edinburgh Postnatal Depression Scale and talk to your ob-gyn, primary care doctor or a perinatal psychiatrist.

Find a postpartum depression specialist near you

Call or text the National Maternal Mental Health Hotline at 1-833-TLC-MAMA (1-833-852-6262), 24 hours a day. If you have thoughts of harming yourself, call or text 988.
When Zurzuvae was approved, it was the first pill licensed specifically for postpartum depression — we covered what the FDA approval actually meant at the time.

Frequently Asked Questions

What is Zurzuvae used for?

Zurzuvae is FDA-approved to treat postpartum depression in adults. It is not approved for other types of depression.

How fast does Zurzuvae work?

In clinical trials, depression scores improved significantly by day 3, with the largest measured differences at day 15 and a month after treatment ended.

What are the side effects of Zurzuvae?

The most common are sleepiness, dizziness, diarrhea, fatigue and memory problems. It has a boxed warning for driving impairment: don’t drive for at least 12 hours after a dose.

Can I breastfeed while taking Zurzuvae?

Very little passes into breast milk, and LactMed says it is not a reason to stop breastfeeding, but babies should be watched for excessive sleepiness.

How long do you take Zurzuvae?

One 50 mg dose each evening for 14 days.

Why do you only take Zurzuvae for 14 days?

That’s the course studied in the trials that led to approval, and the FDA label says safety and effectiveness beyond 14 days in a single course haven’t been established. In the trials, the benefit lasted at least a month after the last dose.

Does Zurzuvae make you feel high?

At prescribed doses, sleepiness is the usual effect. In a study designed to test misuse potential, higher doses produced euphoric mood, feeling drunk and “drug liking” scores comparable to alprazolam.

How is Zurzuvae different from antidepressants?

It works on GABA-A receptors rather than serotonin, is taken for 14 days instead of months, worked within days in trials rather than weeks, and is approved specifically for postpartum depression.

Can my OB prescribe Zurzuvae?

Yes. An ob-gyn, midwife or family doctor can prescribe it; a psychiatry referral isn’t required.

Is Zurzuvae a controlled substance?

Yes. It is Schedule IV. In a formal study its misuse potential was comparable to alprazolam, and some people had withdrawal-like symptoms after stopping.

Where do I get Zurzuvae filled?

It’s usually dispensed through a specialty pharmacy, often after your insurance approves it. Your prescriber’s office or the ZURZUVAE For You program can help.

What do people say about Zurzuvae?

Experiences vary. In clinical trials, most women completed treatment, sleepiness was the most common side effect, and many improved within days, but about half were not in remission after two weeks.

Can I take Zurzuvae with my antidepressant?

Yes. The label says it can be taken alone or added to an existing oral antidepressant.

Does insurance cover Zurzuvae?

Many plans cover it, often with prior authorization. The manufacturer offers a savings card for eligible commercially insured patients.

PostpartumDepression.org Team
Reviewed by:Kimberly Langdon M.D.

Medical Editor

  • Fact-Checked
  • Editor

Kimberly Langdon is a Doctor of Medicine and graduated from The Ohio State University in 1991. She completed her residency in Obstetrics and Gynecology at The Ohio State University Hospitals, Department of OB/GYN. Board-Certified in 1997, she is now retired from clinical practice after a long and successful career. Currently, she is the Founder and Chief Medical Officer of a Medical Device Company that is introducing patented products to treat vaginal microbial infections without the need for drugs. She is an expert in Vaginal Infections, Menstrual disorders, Menopause, and Contraception.

Written by:

Jenna Carberg was diagnosed with postpartum depression following the birth of her daughter in 2016. It was a healthy birth but in the following days, Jenna's mood changed quickly. Doctors suggested that it might be the "baby blues", but her husband Chris suggested she seek a second opinion. Jenna was diagnosed with postpartum depression and began a journey that lasted 9 long months with significant ups and downs. Jenna's mental health care and her experiences became a passion for her to share with the world. She and her husband Chris founded PostpartumDepression.org as a support website designed to help women suffering in silence and their loved ones.

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