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Zurzuvae
zuranolone
Black Box Warnings .
Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities
causes driving impairment due to CNS depressant effects; advise patients not to drive or engage in other potentially hazardous activities for at least 12h after each dose; inform patients they may not be able to assess driving competence or degree of impairment
Adult Dosing .
Dosage forms: CAP: 20 mg, 25 mg, 30 mg
postpartum depression
- [50 mg PO qpm x14 days]
- Info: give with fat-containing food; may decr. dose to 40 mg PO qpm if CNS depression occurs
renal dosing
- [adjust dose amount]
- eGFR 15-59: 30 mg qpm x14 days; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class C: 30 mg qpm x14 days
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: driving for at least 12h after dose
- caution: patients of childbearing potential
- caution: patients <25 yo
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: substance abuse history
- caution: eGFR <60
- caution: hepatic impairment, Child-Pugh Class C
Drug Interactions .
Overview
zuranolone
GABA modulator
- CYP3A4 substrate
- CNS depression
Avoid/Use Alternative
- 5-HTP
- aldesleukin
- alfentanil
- allopurinol
- almotriptan
- alprazolam
- amantadine
- amitriptyline
- amoxapine
- apalutamide
- apomorphine
- apraclonidine ophthalmic
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- armodafinil
- artemether/lumefantrine
- asenapine
- baclofen
- baclofen intrathecal
- belzutifan
- bexarotene
- bosentan
- brexpiprazole
- brigatinib
- brimonidine topical
- brivaracetam
- bromocriptine
- brompheniramine
- buprenorphine
- buspirone
- butalbital
- butorphanol
- cannabidiol
- cannabis
- carbamazepine
- carbinoxamine
- cariprazine
- carisoprodol
- cenobamate
- ceritinib
- cetirizine
- chamomile, German
- chlophedianol
- chlorcyclizine
- chlordiazepoxide
- chlorpheniramine
- chlorpromazine
- chlorzoxazone
- clemastine
- clobazam
- clomipramine
- clonazepam
- clonidine
- clorazepate
- clozapine
- codeine
- cyclobenzaprine
- cyproheptadine
- dabrafenib
- danshen
- dantrolene
- daridorexant
- darifenacin
- darolutamide
- desflurane
- desipramine
- deutetrabenazine
- dexamethasone
- dexbrompheniramine
- dexchlorpheniramine
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- dichlorphenamide
- dicloxacillin
- difelikefalin
- difenoxin
- dihydrocodeine
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- domperidone
- doxepin
- doxepin topical
- doxylamine
- dronabinol
- droperidol
- echinacea
- efavirenz
- elafibranor
- elagolix
- eletriptan
- elinzanetant
- enasidenib
- encorafenib
- entacapone
- entrectinib
- enzalutamide
- esketamine
- eslicarbazepine acetate
- estazolam
- eszopiclone
- ethanol (alcoholic beverage)
- ethanol (in some formulations)
- ethanol injection
- ethosuximide
- etomidate
- etravirine
- felbamate
- fenfluramine
- fentanyl
- fesoterodine
- fexinidazole
- flibanserin
- fluphenazine
- flurazepam
- fosamprenavir
- foslevodopa
- fosphenytoin
- frovatriptan
- gabapentin
- gabapentin enacarbil
- ganaxolone
- garlic
- ginkgo
- ginseng, Asian
- glofitamab
- glycerol phenylbutyrate
- glycopyrrolate
- griseofulvin
- guanfacine
- haloperidol
- hydrocodone
- hydromorphone
- hydroxyzine
- hyoscyamine
- ifosfamide
- iloperidone
- imipramine
- isocarboxazid
- isoflurane
- ivosidenib
- kava
- ketamine
- kratom
- lacosamide
- lamotrigine
- lemborexant
- levetiracetam
- levocetirizine
- levodopa
- levorphanol
- linvoseltamab
- lofexidine
- lorazepam
- lorlatinib
- loxapine
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- mavacamten
- meclizine
- melatonin
- meperidine
- meprobamate
- metaxalone
- methadone
- methocarbamol
- methohexital
- methsuximide
- methyldopa
- metoclopramide
- metyrapone
- metyrosine
- midazolam
- milnacipran
- milsaperidone
- mitapivat
- mitotane
- mobocertinib
- modafinil
- molindone
- morphine
- mosunetuzumab
- mycophenolate mofetil
- nafcillin
- nalbuphine
- naltrexone
- naratriptan
- nelarabine
- nevirapine
- nortriptyline
- odevixibat
- olanzapine
- oliceridine
- olutasidenib
- omaveloxolone
- opicapone
- opium
- orphenadrine
- oxazepam
- oxcarbazepine
- oxybate
- oxybutynin
- oxycodone
- oxymorphone
- pacritinib
- paliperidone
- passion flower
- pentazocine
- pentobarbital
- perampanel
- perphenazine
- pexidartinib
- phenelzine
- pheniramine
- phenobarbital
- phenytoin
- pimozide
- pioglitazone
- pramipexole
- prednisone
- pregabalin
- primidone
- procarbazine
- prochlorperazine
- promethazine
- propofol
- protriptyline
- pyrilamine
- quazepam
- quetiapine
- ramelteon
- rasagiline
- remifentanil
- remimazolam
- repotrectinib
- rifabutin
- rifampin
- rifapentine
- risperidone
- rizatriptan
- ropeginterferon alfa-2b
- ropinirole
- rotigotine transdermal
- rufinamide
- safinamide
- sarilumab
- scopolamine
- selegiline
- selegiline transdermal
- selinexor
- sevoflurane
- solifenacin
- sotorasib
- St. John's wort
- stiripentol
- sufentanil
- sumatriptan
- sunvozertinib
- suvorexant
- suzetrigine
- tapentadol
- tasimelteon
- tazemetostat
- tecovirimat
- telotristat ethyl
- temazepam
- tetrabenazine
- thalidomide
- thioridazine
- thiotepa
- thiothixene
- tiagabine
- tizanidine
- tocilizumab
- tolcapone
- tolterodine
- topiramate
- tovorafenib
- tradipitant
- tramadol
- tranylcypromine
- triazolam
- trifluoperazine
- trihexyphenidyl
- trimethobenzamide
- trimipramine
- triprolidine
- trospium
- valbenazine
- valerian
- valproic acid
- vamorolone
- vemurafenib
- vigabatrin
- viloxazine
- vinblastine
- vorasidenib
- zaleplon
- zanubrutinib
- ziconotide
- ziprasidone
- zolmitriptan
- zolpidem
- zonisamide
Monitor/Modify Tx
- adagrasib
- atazanavir
- chloramphenicol
- clarithromycin
- cobicistat
- idelalisib
- itraconazole
- ketoconazole
- levoketoconazole
- lonafarnib
- lopinavir/ritonavir
- mifepristone
- mirtazapine
- nefazodone
- nelfinavir
- posaconazole
- ribociclib
- ritonavir
- tipranavir
- tucatinib
- voriconazole
Caution Advised
- brimonidine ophthalmic
- citalopram
- desvenlafaxine
- duloxetine
- escitalopram
- fluoxetine
- fluvoxamine
- levomilnacipran
- meropenem
- paroxetine
- sertraline
- trazodone
- vaborbactam
- venlafaxine
- vilazodone
Adverse Reactions .
Serious Reactions
- CNS depression
- confusion, severe
- suicidality
- depression exacerbation
- abuse
- dependency
Common Reactions
- somnolence
- dizziness
- nasopharyngitis
- diarrhea
- fatigue
- UTI
- xerostomia
- impaired memory
- abdominal pain
- sinus congestion
- tremor
- hypoesthesia
- muscle twitching
- myalgia
- anxiety
- rash
Safety/Monitoring .
Monitoring Parameters
eGFR at baseline; signs/symptoms of depression, behavior changes, suicidality
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; risk of developmental toxicity, including embryo-fetal death and fetal malformations, based on animal data at >7x MRHD; possible risk of fetal neurodegeneration based on animal data at >1x MRHD
Pregnancy Registry
encourage patients to enroll in National Pregnancy Registry for Antidepressants at 1-844-405-6185 or www.womensmentalhealth.org/research/pregnancyregistry/antidepressants
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x1wk after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm, though drug excreted into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for zuranolone: liver extensively; CYP450: 3A4 substrate
Excretion: for zuranolone: urine 45%, feces 41% (<2% unchanged); Half-life: 19.7-24.6h
Subclass: Allopregnanolone Analogs
Mechanism of Action
for zuranolone: exact mechanism of action unknown; neuroactive steroid provides positive allosteric modulation of GABA-A receptors
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Sage Therapeutics and Biogen Inc.
DEA/FDA: Schedule IV
Retail Price
This information is currently not available for this drug.
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