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Drug overview for ZURZUVAE (zuranolone):
Generic name: zuranolone (zoo-RAN-oh-lone)
Drug class: Antidepressant Neuroactive Steroid GABA-A Receptor Modulator
Therapeutic class: Central Nervous System Agents
Zuranolone, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator, is an antidepressant.
No enhanced Uses information available for this drug.
Generic name: zuranolone (zoo-RAN-oh-lone)
Drug class: Antidepressant Neuroactive Steroid GABA-A Receptor Modulator
Therapeutic class: Central Nervous System Agents
Zuranolone, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator, is an antidepressant.
No enhanced Uses information available for this drug.
DRUG IMAGES
ZURZUVAE 30 MG CAPSULE
ZURZUVAE 20 MG CAPSULE
ZURZUVAE 25 MG CAPSULE
The following indications for ZURZUVAE (zuranolone) have been approved by the FDA:
Indications:
Postpartum depression
Professional Synonyms:
Postnatal depression
Puerperal depression
Indications:
Postpartum depression
Professional Synonyms:
Postnatal depression
Puerperal depression
The following dosing information is available for ZURZUVAE (zuranolone):
If patients experience CNS depressant effects within the 14-day treatment period, consider reducing the dosage of zuranolone to 40 mg orally once daily in the evening.
When used concomitantly with a strong cytochrome P-450 (CYP) 3A4 inhibitor, reduce the zuranolone dosage to 30 mg orally once daily in the evening for 14 days.
No dosage modification is recommended when zuranolone is used concomitantly with a moderate CYP3A4 inhibitor.
Avoid concomitant use of zuranolone with CYP3A4 inducers.
When used concomitantly with a strong cytochrome P-450 (CYP) 3A4 inhibitor, reduce the zuranolone dosage to 30 mg orally once daily in the evening for 14 days.
No dosage modification is recommended when zuranolone is used concomitantly with a moderate CYP3A4 inhibitor.
Avoid concomitant use of zuranolone with CYP3A4 inducers.
Zuranolone is administered orally as capsules. Zuranolone should be taken with fat-containing food (e.g., 400--1000 calories, 25% to 50% fat). Zuranolone can be used alone or as an adjust to oral antidepressant therapy.
The safety and efficacy of zuranolone use beyond 14 days in a single treatment course have not been established. If a zuranolone evening dose is missed, the patient should be advised to take the next dose at the regular time the following evening. The patient should be advised to not take extra capsules on the same day to make up for the missed dose.
The patient should then continue taking zuranolone once daily until the remainder of the 14-day treatment course is complete. Store zuranolone capsules at 20-25degreesC; excursions permitted between 15-30degreesC.
The safety and efficacy of zuranolone use beyond 14 days in a single treatment course have not been established. If a zuranolone evening dose is missed, the patient should be advised to take the next dose at the regular time the following evening. The patient should be advised to not take extra capsules on the same day to make up for the missed dose.
The patient should then continue taking zuranolone once daily until the remainder of the 14-day treatment course is complete. Store zuranolone capsules at 20-25degreesC; excursions permitted between 15-30degreesC.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZURZUVAE 20 MG CAPSULE | Maintenance | Adults take 2 capsules (40 mg) by oral route once daily for 14 days |
| ZURZUVAE 25 MG CAPSULE | Maintenance | Adults take 2 capsules (50 mg) by oral route once daily for 14 days |
| ZURZUVAE 30 MG CAPSULE | Maintenance | Adults take 1 capsule (30 mg) by oral route once daily for 14 days |
No generic dosing information available.
The following drug interaction information is available for ZURZUVAE (zuranolone):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Zuranolone/CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inducers of CYP3A4 may induce the metabolism of zuranolone.(1) CLINICAL EFFECTS: Concurrent use of a CYP3A4 inducer may result in a loss of zuranolone efficacy.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: Avoid the concurrent use of zuranolone with CYP3A4 inducers.(1) DISCUSSION: Coadministration of zuranolone with rifampin decreased the maximum concentration (Cmax) by 0.31-fold and area-under-curve (AUC) by 0.15-fold.(1) Strong CYP3A4 inducers linked to this monograph include: apalutamide, barbiturates, carbamazepine, encorafenib, enzalutamide, fosphenytoin, ivosidenib, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin, rifapentine, and St. John's wort. Moderate CYP3A4 inducers linked to this monograph include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, repotrectinib, rifabutin, sotorasib, telotristat ethyl, thioridazine, and tovorafenib. Weak CYP3A4 inducers linked to this monograph include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, eslicarbazepine, flucloxacillin, garlic, genistein, ginseng, glycyrrhizin, methylprednisolone, mobocertinib, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, quercetin, relugolix, rufinamide, sarilumab, sulfinpyrazone, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(2,3) |
ACTOPLUS MET, ACTOS, ALOGLIPTIN-PIOGLITAZONE, ALUNBRIG, APTIOM, ARMODAFINIL, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, AUGTYRO, BANZEL, BEXAROTENE, BOSENTAN, BRAFTOVI, BRIVIACT, BRUKINSA, BUPIVACAINE-DEXAMETH-EPINEPHRN, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL, BUTALBITAL-ACETAMINOPHEN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, CAMZYOS, CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, CLOBAZAM, DEPO-MEDROL, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DICLOXACILLIN SODIUM, DILANTIN, DILANTIN-125, DMT SUIK, DONNATAL, DOUBLEDEX, DUETACT, DUZALLO, EFAVIRENZ, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EPITOL, EPRONTIA, EQUETRO, ERLEADA, ETRAVIRINE, FIORICET, FIORICET WITH CODEINE, FOSPHENYTOIN SODIUM, HEMADY, INTELENCE, KEVZARA, KIMYRSA, LIDOCIDEX-I, LORBRENA, LUMAKRAS, LYSODREN, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MITOTANE, MODAFINIL, MYFEMBREE, MYSOLINE, NAFCILLIN, NAFCILLIN SODIUM, NEVIRAPINE, NEVIRAPINE ER, NUBEQA, NUVIGIL, OJEMDA, ONFI, ORBACTIV, ORGOVYX, ORIAHNN, ORILISSA, ORKAMBI, OSENI, OXCARBAZEPINE, OXCARBAZEPINE ER, OXTELLAR XR, PENTOBARBITAL SODIUM, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PIOGLITAZONE HCL, PIOGLITAZONE-GLIMEPIRIDE, PIOGLITAZONE-METFORMIN, PRIFTIN, PRIMIDONE, PROVIGIL, PYRUKYND, QSYMIA, QUDEXY XR, RIFABUTIN, RIFADIN, RIFAMPIN, RUFINAMIDE, SEZABY, SKYCLARYS, SOLU-MEDROL, SYMFI, SYMFI LO, SYMPAZAN, TAFINLAR, TALICIA, TAPERDEX, TARGRETIN, TAZVERIK, TEGRETOL, TEGRETOL XR, TENCON, TERBINAFINE HCL, THIORIDAZINE HCL, THIORIDAZINE HYDROCHLORIDE, TIBSOVO, TOPAMAX, TOPIRAMATE, TOPIRAMATE ER, TPOXX (NATIONAL STOCKPILE), TRACLEER, TRILEPTAL, TROKENDI XR, TURALIO, VINBLASTINE SULFATE, VONJO, WAKIX, WELIREG, XCOPRI, XERMELO, XTANDI, ZCORT, ZELBORAF |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Zuranolone/Strong CYP3A4 Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Strong inhibitors of CYP3A4 may inhibit the metabolism of zuranolone.(1) CLINICAL EFFECTS: Concurrent use of strong CYP3A4 inhibitors may increase the levels and effects of zuranolone, including somnolence and CNS depression.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US prescribing information recommends dose adjustment if zuranolone is to be given with a strong CYP3A4 inhibitor. Reduce the zuranolone dose to 30 mg orally once daily in the evening for 14 days when used concurrently with strong CYP3A4 inhibitors.(1) DISCUSSION: Coadministration of zuranolone with itraconazole (a strong CYP3A4 inhibitor) increased the maximum concentration (Cmax) by 25% and area-under-curve (AUC) by 62%.(1) Strong inhibitors of CYP3A4 include: adagrasib, boceprevir, ceritinib, clarithromycin, cobicistat, idelalisib, indinavir, itraconazole, josamycin, ketoconazole, levoketoconazole, lonafarnib, lopinavir, mibefradil, mifepristone, nefazodone, nelfinavir, nirmatrelvir, paritaprevir, posaconazole, ribociclib, saquinavir, telaprevir, telithromycin, tipranavir, troleandomycin, tucatinib, and voriconazole.(2,3) |
APTIVUS, CLARITHROMYCIN, CLARITHROMYCIN ER, EVOTAZ, GENVOYA, ITRACONAZOLE, ITRACONAZOLE MICRONIZED, KALETRA, KETOCONAZOLE, KISQALI, KORLYM, KRAZATI, LANSOPRAZOL-AMOXICIL-CLARITHRO, LOPINAVIR-RITONAVIR, MIFEPREX, MIFEPRISTONE, NEFAZODONE HCL, NOXAFIL, OMECLAMOX-PAK, PAXLOVID, POSACONAZOLE, PREZCOBIX, RECORLEV, SPORANOX, STRIBILD, SYMTUZA, TOLSURA, TUKYSA, TYBOST, VFEND, VFEND IV, VIRACEPT, VOQUEZNA TRIPLE PAK, VORICONAZOLE, ZOKINVY, ZYDELIG, ZYKADIA |
The following contraindication information is available for ZURZUVAE (zuranolone):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Child-pugh class C hepatic impairment |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Disease of liver |
| Suicidal ideation |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for ZURZUVAE (zuranolone):
Adverse reaction overview.
The most common adverse effects of zuranolone (>=5% of patients) reported in clinical studies include somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
The most common adverse effects of zuranolone (>=5% of patients) reported in clinical studies include somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Suicidal ideation |
| Rare/Very Rare |
|---|
| None. |
There are 18 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Dizziness Drowsy Fatigue Nasal passage irritation Urinary tract infection |
Accidental fall Acute abdominal pain Hypoesthesia Memory impairment Muscle fasciculation Myalgia Sinusitis Skin rash Symptoms of anxiety Toothache Tremor Xerostomia |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ZURZUVAE (zuranolone):
Safety and effectiveness of zuranolone in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There is insufficient evidence with zuranolone in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Based on findings from animal studies, zuranolone may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
In animals, oral administration of zuranolone to pregnant rats during organogenesis resulted in developmental toxicity, including embryofetal death and fetal malformations, with a no 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 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. Development 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. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including zuranolone, 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/.
In animals, oral administration of zuranolone to pregnant rats during organogenesis resulted in developmental toxicity, including embryofetal death and fetal malformations, with a no 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 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. Development 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. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including zuranolone, 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/.
Available data from a clinical lactation study in 14 lactating women indicate that zuranolone is present in low levels in human milk. There are no data on the effects of zuranolone on the breast-fed infant and limited data on the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zuranolone and any potential adverse effects on the breast-fed child from zuranolone or from the underlying maternal condition.
A steady-state milk study was conducted in 14 healthy lactating women treated with daily oral administration of 30 mg of zuranolone for 5 days. At steady state (Day 5), the calculated maximum relative infant dose for zuranolone was <1%. The daily infant dose was low (approximately 0.0013 mg/kg per day), reflecting a mean relative infant dose of 0.357%
compared to the maternal dose. Concentrations of zuranolone in breast milk were below the level of quantification limit by 4--6 days after the last dose.
A steady-state milk study was conducted in 14 healthy lactating women treated with daily oral administration of 30 mg of zuranolone for 5 days. At steady state (Day 5), the calculated maximum relative infant dose for zuranolone was <1%. The daily infant dose was low (approximately 0.0013 mg/kg per day), reflecting a mean relative infant dose of 0.357%
compared to the maternal dose. Concentrations of zuranolone in breast milk were below the level of quantification limit by 4--6 days after the last dose.
There is no experience with zuranolone in geriatric patients with postpartum depression.
The following prioritized warning is available for ZURZUVAE (zuranolone):
WARNING: This drug may make you dizzy, drowsy, or slow down thinking. This may cause you to be at a higher risk for falls while taking this medication. You may not be able to tell on your own how much zuranolone is affecting you or if you can drive or do other activities safely.
Do not drive, use machinery, or do anything that needs alertness for at least 12 hours after taking this medication. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
WARNING: This drug may make you dizzy, drowsy, or slow down thinking. This may cause you to be at a higher risk for falls while taking this medication. You may not be able to tell on your own how much zuranolone is affecting you or if you can drive or do other activities safely.
Do not drive, use machinery, or do anything that needs alertness for at least 12 hours after taking this medication. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
The following icd codes are available for ZURZUVAE (zuranolone)'s list of indications:
| Postpartum depression | |
| F53.0 | Postpartum depression |
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