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Zuranolone

Also known as: Zurzuvae

Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive ModulatorGABA A Receptor Positive Modulators

Route: Oral

4 interactions on record⛔ Black Box Warning

Zuranolone has 4 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Cyp3a Inducers, Mao Inhibitors, Alcohol. Patients taking Zuranolone should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Major: 2
Moderate: 2

Major (2)

Zuranolone + Cyp3a Inducers— Concomitant use decreases zuranolone exposure and may reduce efficacy of ZURZUVAE. Avoid concomitant use.
Zuranolone + Mao Inhibitors— Concomitant use increases zuranolone exposure and may increase risk of ZURZUVAE-associated adverse reactions. Reduce ZUR…

Moderate (2)

Zuranolone + Alcohol— Concomitant use may increase impairment of psychomotor performance or CNS depressant effects. Consider dosage reduction …
Zuranolone + Cns-Depressant Drugs— Concomitant use may increase impairment of psychomotor performance or CNS depressant effects. Consider dosage reduction …

Zuranolone + Cyp3a Inducers⚠️Major

Concomitant use decreases zuranolone exposure and may reduce efficacy of ZURZUVAE. Avoid concomitant use.

Zuranolone + Mao Inhibitors⚠️Major

Concomitant use increases zuranolone exposure and may increase risk of ZURZUVAE-associated adverse reactions. Reduce ZURZUVAE dosage to 30 mg once daily.

Zuranolone + Alcohol🟡Moderate

Concomitant use may increase impairment of psychomotor performance or CNS depressant effects. Consider dosage reduction if use is unavoidable.

Zuranolone + Cns-Depressant Drugs🟡Moderate

Concomitant use may increase impairment of psychomotor performance or CNS depressant effects. Consider dosage reduction if use is unavoidable.

⛔ FDA Black Box Warning

WARNING: 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 ) .

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including ZURZUVAE, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/ Risk Summary Based on findings from animal studies, ZURZUVAE may cause fetal harm. Advise pregnant women of the potential risk to a fetus. Available data on ZURZUVAE use in pregnant women from the clinical development program are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animals, oral administration of zuranolone to pregnant rats during organogenesis resulted in developmental toxicity, including embryofetal death and fetal malformations, with a no observed adverse effect level (NOAEL) associated with maternal plasma exposures 7 times greater than in humans at the maximum recommended human dose (MRHD) of 50 mg. Oral administration of zuranolone to pregnant mice resulted in developmental toxicity, including decreased fetal body weight, reduced skeletal ossification, and fetal malformations with a NOAEL associated with a maternal plasma exposure similar to that in humans at the MRHD. Oral administration of zuranolone to rats during pregnancy and lactation resulted in developmental toxicity in the offspring, including, perinatal mortality, at maternal exposures similar to that in humans at the MRHD. Developmental toxicity was observed at doses that were also maternally toxic. Neuronal death was observed in rats exposed to zuranolone during a period of brain development that begins during the third trimester of pregnancy in humans and continues up to a few years after birth. The estimated background risk of major birth defects and miscarriage for the indicated populat

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.