Zurzuvae Side Effects: What to Expect Over the 14 Days
The most common Zurzuvae side effect is sleepiness, felt by 36% of women on 50 mg against 6% on placebo. You can't drive for 12 hours after each dose.
By withClaro Editorial · Medically reviewed by Dr. Jason Tan , Consultant Psychiatrist · 2026-11-09 · 8 min read
Key takeaways Sleepiness is by far the most common side effect, about six times as frequent as on placebo in the 50 mg trial. Dizziness, diarrhea, tiredness and urinary tract infections were also more common than on placebo. Only 2% stopped because of side effects, but about 1 in 6 had their dose lowered, mostly for sleepiness. A boxed warning rules out driving for at least 12 hours after each dose, for the 14 days of the course. Alcohol, benzodiazepines and opioids add to the drowsiness, and healthy volunteers had mild withdrawal-type symptoms after stopping. Most of what OB-GYN Dr. Hector Chapa says about the side effects holds up. His claim that the FDA advises stopping breastfeeding for 21 days does not. On this page
What are the most common side effects of Zurzuvae? How much of what Dr. Chapa says about Zurzuvae side effects holds up? Why does Zurzuvae make you so sleepy, and is it like a benzo? Why can't you drive for 12 hours after taking Zurzuvae? Can Zurzuvae cause withdrawal or dependence? Which Zurzuvae side effects are serious? Does Zurzuvae affect breastfeeding? What to track and tell your doctor during the 14 days Zurzuvae side effects center on sleepiness. In the main 2023 trial of 50 mg, 36% of women felt sleepy, against 6% on placebo. Dizziness, diarrhea, tiredness and urinary tract infections came next. Zuranolone side effects are strong enough for a boxed warning: no driving for 12 hours after each dose.
OB-GYN Dr. Hector Chapa teaches at Texas A&M College of Medicine. He walked through the new drug in an August 2023 episode of his podcast, Dr. Chapa's OBGYN Clinical Pearls. He recorded it six days after FDA approval. We checked eight of his claims about side effects against the FDA label, the main trial and a driving study.
What are the most common side effects of Zurzuvae?
Sleepiness leads by a wide margin, and everything else on the list is far less common. The FDA label lists side effects from the 2023 SKYLARK trial of 50 mg. Each one showed up in at least 2% of women, and more often than on placebo. Memory problems and stomach pain were rare, but no one on placebo had them.
Side effect Zurzuvae 50 mg Placebo Sleepiness, including sedation 36% 6% Dizziness, including vertigo 13% 9% Diarrhea 6% 2% Tiredness or weakness 5% 2% Urinary tract infection 5% 4% Memory problems 3% 0% Stomach pain 3% 0% Tremor 2% 0% Numbness or reduced feeling 2% 0% Muscle twitching 2% 0% Muscle pain 2% 0% COVID-19 2% 0% Anxiety 2% 1% Rash 2% 1%
A second trial, ROBIN, used a dose close to 40 mg. Sleepiness there was 19% against 11% on placebo, and a cold-like sore throat or stuffy nose 9% against 3%.
Few women quit over side effects, 2% on the drug and 1% on placebo, mostly because of sleepiness. Still, 16% in SKYLARK had their dose lowered for a side effect, most often sleepiness or dizziness. If you still feel groggy by mid-morning, tell your prescriber, because a dose change is an option the label allows.
How much of what Dr. Chapa says about Zurzuvae side effects holds up?
Six of his eight claims hold up, one needs a caveat and one does not hold up. His list of common side effects, the boxed warning, the 12-hour rule and the link to GABA all match the label. Calling the drug well tolerated plays down how often doses were lowered. His breastfeeding claim is not in the label.
Summing up the trial data, Dr. Chapa said:
The most common side effects greater than 5% recorded were somnolence, dizziness, diarrhea, fatigue, and urinary tract infection.
In the label's table for the 50 mg trial, sleepiness, dizziness, diarrhea, urinary tract infections and tiredness are the top five. Tiredness and urinary tract infections sit at exactly 5%, not more.
What Dr. Chapa said What the research found Does it hold up? The most common side effects, above 5%, are sleepiness, dizziness, diarrhea, tiredness and urinary tract infections The label lists the same five, at 5% or more, for the 50 mg trial. Urinary tract infections were close to placebo, at 5% against 4% Yes The drug was generally well tolerated, with the same safety profile in both trials In the 2023 trial, 2% stopped because of side effects, against 1% on placebo. Yet 16% had their dose lowered, mostly for sleepiness Partly. One in six needed a smaller dose Because it acts on GABA, it is a depressant of the central nervous system The label warns of nervous system depressant effects such as sleepiness and confusion. It says the GABA-A link is thought to explain how it works Yes, though the mechanism is not fully known Sleepiness comes from the same GABA-A action as benzodiazepines, barbiturates and alcohol Taken with alcohol or alprazolam, it impaired coordination more. Its abuse potential is comparable to alprazolam. It is a neuroactive steroid, not a benzodiazepine Yes, though it is not a benzodiazepine The FDA added a boxed warning that it can impair driving and other hazardous activities The boxed warning covers driving and other risky tasks, and adds that people may not notice their own impairment Yes No driving for 12 hours after each dose, for the 14 days, not for the full 45 days The label says at least 12 hours after each dose, for the 14-day course. A 2025 simulator study found driving still impaired 9 hours after a dose Yes There are no breastfeeding data, and the FDA advises stopping for the 14 days plus 7 more The August 2023 label already had milk data from 14 women. It asked doctors to weigh the benefits of breastfeeding, not to stop. The extra week applies to birth control Not supported. The FDA gave no advice to stop. Data on breastfed babies are indeed missing One 50 mg dose each evening for 14 days, and then treatment is over The label says 50 mg each evening for 14 days, with food that contains fat, or 40 mg if sleepiness or confusion is strong Yes
He is right about what shapes the two weeks day to day: sleepiness, the 12-hour rule and its 14-day limit. His breastfeeding claim is in neither the 2023 nor the current label. The extra week after the course there applies to birth control. If you drive or breastfeed, take the rows on driving and breastfeeding to your prescriber.
Why does Zurzuvae make you so sleepy, and is it like a benzo?
Zuranolone strengthens GABA-A receptors, the brain's main braking system, so it slows the brain down. That is why sleepiness, dizziness and confusion lead the list. It is a neuroactive steroid, not a benzodiazepine. Even so, the label rates its abuse potential as comparable to alprazolam (Xanax) and lists it as a Schedule IV controlled substance.
Dr. Chapa put zuranolone in the same family as older calming drugs:
Other medications that are in that same category but are used for different indications include things like benzodiazepines or barbiturates or ethanol. And that's why you get this sedation effect.
The label bears out the practical side of that. In testing, daily doses taken with alcohol or alprazolam worsened coordination and reaction time more. Other benzodiazepines, opioids and tricyclic antidepressants also add to the slowing. So do strong CYP3A4 inhibitors, medicines that raise zuranolone levels in the blood.
If strong sleepiness or confusion appears, your prescriber may move you to 40 mg for the rest of the course. Before day 1, show your prescriber every sleep aid, pain medicine and anxiety medicine you take.
Why can't you drive for 12 hours after taking Zurzuvae?
The boxed warning says zuranolone can impair driving even when you feel alert. For at least 12 hours after each dose, you should not drive or operate machinery. It also warns that you may not be able to judge how impaired you are. The rule covers the 14 days of the course, not the weeks after it.
A 2025 driving-simulator study of 67 healthy adults supports the warning. Lane control was worse 9 hours after a 50 mg dose, on day 2 and again on day 8. Most people still judged themselves fit to drive.
The label also warns that sleepiness and confusion can raise the risk of falls. That matters if you carry your baby at night. Before day 1, decide with your partner or family who handles morning drives and night feeds for the two weeks.
Can Zurzuvae cause withdrawal or dependence?
It can cause physical dependence. Healthy volunteers took 50 mg for only 6 to 7 days, shorter than the full course. They then had mild to moderate symptoms after stopping. These included trouble sleeping, a racing heartbeat, nightmares, nausea, sweating, less appetite and paranoia.
In SKYLARK, no withdrawal symptoms were seen in women with postpartum depression. The course stops at day 14, and the label says safety beyond 14 days in one course has not been established.
Note your sleep, heartbeat and mood for the first few days after the last capsule. Tell your prescriber about anything new, so they can tell a passing reaction from returning depression.
Which Zurzuvae side effects are serious?
Confusion is the serious side effect the label names, in 1% of women in the trials. Tell your prescriber about new confusion or a fall. The label warns about both, and your prescriber may lower the dose or stop the drug. Going by tests in rats, the label warns it may harm an unborn baby. Effective birth control is advised during the course and for 1 week after.
Call 911 or 988 now if you feel you might act on thoughts of suicide, or you have a seizure, a very high temperature with stiff muscles, or swelling of the face or throat.
Call your prescriber the same day, or get urgent care, if you notice:
new or worse thoughts of suicide or self-harm, especially early on, after a dose change, or in people under 25 Medical review Medically reviewed by Dr. Jason Tan, Consultant Psychiatrist, on 27 October 2026, this section only. Next review: 27 October 2027.
The zuranolone label carries the same warning about suicidal thoughts that antidepressants share. If you're having thoughts of harming yourself, contact emergency services or a crisis line straight away. In the US, call or text 988. In the UK, call Samaritans on 116 123. Elsewhere, find a crisis line near you .
Does Zurzuvae affect breastfeeding?
A small amount reaches breast milk, and how it affects breastfed babies has not been studied. A study gave 14 healthy breastfeeding women 30 mg, less than the usual 50 mg. A baby would get about 0.357% of the mother's dose. Milk levels were too low to measure 4 to 6 days after the last dose.
The label does not tell you to stop breastfeeding. It asks you and your doctor to weigh its benefits against your need for the drug. Any possible effect on the baby counts too.
Settle on a feeding plan with your OB and your baby's pediatrician before day 1. For more on breastfeeding during the course and who it suits, see how zuranolone works for postpartum depression .
What to track and tell your doctor during the 14 days
A short daily note gives your prescriber what the label asks them to watch for. Sleepiness, confusion and mood are the signals that decide whether the dose suits you. Writing them down also helps when broken sleep makes the days blur together. These are the points worth noting from day 1 to a few days after the last dose:
How sleepy you feel each morning, and when it wears off. Dizziness, confusion or any fall. Any alcohol, sleeping pills, opioid pain medicines or benzodiazepines. New medicines or supplements, since some raise zuranolone levels. Thoughts of harming yourself, reported the same day. Changes in sleep, heartbeat or mood after the last dose. Bring the notes to your follow-up visit. The withClaro app lets you log mood, energy and sleep daily and track side effects against your dose. You can share a report with your doctor.
Download on the App Store Sleepiness, dizziness and mood on zuranolone can change from day to day. The withClaro app lets you log mood, energy and sleep each day, track side effects against your dose and share a report with your doctor.
Frequently asked questions How long do Zurzuvae side effects last? The label gives no timeline for each side effect. Zuranolone leaves the body slowly, with a half-life of about 20 to 25 hours. Note when sleepiness eases each day and tell your prescriber if it lasts past the course.
Does Zurzuvae cause weight gain? Weight change is not among the side effects in the label. Less appetite showed up only among symptoms after stopping, in healthy volunteers. If your appetite shifts a lot, mention it at your next visit.
Does Zurzuvae make you feel high? It may, especially above the prescribed dose. In the label's abuse study, its abuse potential grew as the dose went up. Take only the prescribed dose and keep the capsules where others can't reach them.
Can you take Zurzuvae with an SSRI? Yes. The label allows zuranolone alone or added to an oral antidepressant. Some antidepressants add to sleepiness, so tell your prescriber which one you take and at what time.
Sources US Food and Drug Administration. ZURZUVAE (zuranolone) capsules, prescribing information, DailyMed, revised 2026 Dr. Hector Chapa on Dr. Chapa's OBGYN Clinical Pearls. Understanding ZURZUVAE (zuranolone): The First Oral Med for PPD, August 10, 2023 Deligiannidis KM, et al. Zuranolone for the treatment of postpartum depression. American Journal of Psychiatry, 2023 Dunbar J, et al. Effects of zuranolone on next-day simulated driving in healthy adults. Psychopharmacology, 2025 US Food and Drug Administration. ZURZUVAE (zuranolone) capsules, prescribing information, August 2023 Claro articles are for self-monitoring and educational purposes only. They are not a medical device, therapist, or diagnostic tool, and do not replace care from your prescribing clinician. If you are in crisis, contact your care team, emergency services, the Samaritans (UK: 116 123), or the Crisis Text Line (US: text HOME to 741741).
