Zuranolone

ZURZUVAE

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Pronunciation: zoo-RAN-oe-loen (zer-ZOO-vay)

Zuranolone ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Zuranolone ballicule

Zuranolone ZURZUVAE mascot mnemonic cartoon — Visual mnemonic: Zuranolone mascot
**“Zu Zu Zu ran alone”**

What it isOral neurosteroid GABA-A positive allosteric modulator; postpartum depression.

Why this oneA 14-day oral course with response in days, where brexanolone needs a 60-hour infusion.

What limits itDriving is prohibited for 12 hours after each dose. Sedation; Schedule IV, and effect beyond 45 days is unstudied.

Pearls

Take in the evening with fat-containing food.
Strong CYP3A4 inhibitors: reduce to 30 mg; avoid inducers.

Zuranolone molecular structure (skeletal formula) — Molecular structure: Zuranolone

Zuranolone prescription history

Animated chart of estimated U.S. prescriptions per year, Antidepressants (1957–2026). Zuranolone enters in 2023 (estimated).

FDA-approved for

postpartum depression (2023)

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability1 / 4

Sedation liability3 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityBoxed warning: impaired driving. No driving or hazardous activity for at least 12 hours after each dose. Somnolence, additive CNS and respiratory depression with other depressants; abuse and dependence potential (Schedule IV).

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Causes driving impairment from CNS depression; do not drive or engage in hazardous activities for at least 12 h after each dose during the 14-day course.

FDA dosing	Population	Start	Target	Max
Postpartum depression	Adults	50 mg QHS ×14 days	50 mg QHS	50 mg QHS

Renal Moderate-severe (eGFR <60): 30 mg QHS ×14 days; mild: no change

Hepatic Severe (Child-Pugh C): 30 mg QHS ×14 days; mild-moderate: no change

14-day treatment course; safety/effectiveness beyond 14 days not established

Instructions

Take in the evening with fat-containing food (400-1000 cal, 25-50% fat)
Reduce to 40 mg QHS if CNS depressant effects occur
With a strong CYP3A4 inhibitor: reduce to 30 mg; avoid CYP3A4 inducers
Missed dose: take the next dose the following evening; do not double up
Use effective contraception during treatment and for 1 week after the final dose

Available strengths

cap 20, 25, 30 mg

Cautions

CNS depressant effects (somnolence, confusion) and driving impairment; additive with other CNS depressants; fall risk
Suicidal thoughts and behavior (worsening depression)
Embryo-fetal toxicity

Adverse reactions

Somnolence
Dizziness
Diarrhea
Fatigue
Nasopharyngitis
Urinary tract infection

Pregnancy May cause fetal harm based on animal studies (malformations, embryofetal/offspring mortality, neuronal death); human data insufficient.

Lactation Present in human milk at low levels (relative infant dose <1%).

Cost

Zuranolone (ZURZUVAE)

Strength		#/mo	CostPlus
20 mg	cap	30 qd	not offered
25 mg	cap	30 qd	not offered
30 mg	cap	30 qd	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Zuranolone is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2037 est.

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Memory aids: interaction avatars

CYP3A4 substrate

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Self-check

How long is the oral zuranolone course?
14 days.
How long after each dose is driving prohibited?
12 hours.