zuranolone

Derm: rash

EENT: nasopharyngitis, sinus congestion

GI: abdominal pain, diarrhea, dry mouth

MS: muscle twitching, myalgia

Neuro: dizziness, sedation, anxiety, confusion, fatigue, gait disturbances, memory impairment, SUICIDAL THOUGHTS/BEHAVIORS, tremor

Misc: physical dependence

Interactions ⬆ ⬇

Drug-drug:

Use with benzodiazepines or other CNS depressants, including opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, muscle relaxants, and alcohol, may cause profound sedation, loss of consciousness, or respiratory depression; avoid concurrent use; if concurrent use unavoidable, ↓ zuranolone dose.
Strong CYP3A4 inhibitors, including itraconazole, may ↑ levels and risk of toxicity; ↓ zuranolone dose.
Strong CYP3A4 inducers, including rifampin, may ↓ levels and effectiveness; avoid concurrent use.

Availability ⬆ ⬇

Capsules: 20 mg; 25 mg; 30 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 50 mg once daily in the evening for 14 days. If patients experience CNS adverse effects within the 14-day period, consider ↓ dose to 40 mg once daily in the evening within the 14-day period. Concurrent use of strong CYP3A4 inhibitors: 30 mg once daily in the evening for 14 days.

Renal Impairment

PO (Adults ): eGFR <60 mL/min/1.73 m²: 30 mg once daily in the evening for 14 days.

Hepatic Impairment

PO (Adults ): Severe hepatic impairment: 30 mg once daily in the evening for 14 days.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Although not fully understood, thought to be related to positive allosteric modulation of GABA-A receptors.

Therapeutic effects:

Reduction in depressive symptoms.

Classifications ⬆ ⬇

Therapeutic Classification: antidepressants

Pharmacologic Classification: corticosteroids, gamma aminobutyric acid gaba enhancers

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following oral administration unknown. Absorption ↑ with fat-containing foods.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Extensively metabolized in the liver via the CYP3A4 isoenzyme to inactive metabolites. 45% excreted in urine; 41% excreted in feces primarily as metabolites.

Half-Life: 19.7–24.6 hr.

Contr. Subst. Schedule ⬆ ⬇

Time/Action Profile ⬆ ⬇

(↓ in depressive symptoms)

ROUTE	ONSET	PEAK	DURATION
PO	3 days	unknown	at least 45 days

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient to take as directed. If an evening dose is missed, take next dose at the regular time the following evening. Do not take extra capsules on the same day to make up for the missed dose. Continue taking once daily until remainder of 14-day treatment course is completed.
Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care provider before taking any new medications. Advise patient to avoid taking other CNS depressants, including alcohol, benzodiazepines, opioids, and tricyclic antidepressants; may cause falls, somnolence, cognitive impairment, and respiratory depression.
Inform patients that zuranolone causes driving impairment due to CNS depressant effects. Caution patient to avoid driving and other activities requiring alertness until >12 hr after zuranolone 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 zuranolone.
Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care provider immediately if thoughts about suicide or dying, attempts to commit suicide, new or worsening depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worsening irritability, aggression, acting on dangerous impulses, mania, or other changes in mood or behavior occur.
Advise patient about potential risks of misuse, abuse, and substance use disorder (addiction).
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception during treatment with zuranolone and for 1 wk after the final dose. Advise pregnant patients of the potential risk of infant exposed to zuranolone in utero. Advise women with reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to antidepressants, including zuranolone, during pregnancy. Health care providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

11014- Catalent Pharma Solutions, LLC
- 11014-0491-
  - 11014-0491-1- 1 BAG in 1 DRUM (11014-0491-1) / 99980 CAPSULE in 1 BAG

11014- Catalent Pharma Solutions, LLC
- 11014-0492-
  - 11014-0492-1- 1 BAG in 1 DRUM (11014-0492-1) / 100016 CAPSULE in 1 BAG

11014- Catalent Pharma Solutions, LLC
- 11014-0493-
  - 11014-0493-1- 1 BAG in 1 DRUM (11014-0493-1) / 100000 CAPSULE in 1 BAG

48957- PPL Pharma Solutions Riverview LLC
- 48957-0115-
  48957-0115-1- 15 kg in 1 CONTAINER (48957-0115-1)

64406- Biogen MA Inc.
- 64406-029- ZURZUVAE
  64406-029-01- 1 BOTTLE in 1 CARTON (64406-029-01) / 14 CAPSULE in 1 BOTTLE

64406- Biogen MA Inc.
- 64406-030- ZURZUVAE
  - 64406-030-01- 1 BOTTLE in 1 CARTON (64406-030-01) / 14 CAPSULE in 1 BOTTLE

64406- Biogen MA Inc.
- 64406-030- ZURZUVAE
  - 64406-030-02- 1 CARTON in 1 CARTON (64406-030-02) / 1 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK

64406- Biogen MA Inc.
- 64406-031- ZURZUVAE
  - 64406-031-01- 1 BOTTLE in 1 CARTON (64406-031-01) / 14 CAPSULE in 1 BOTTLE

69988- Catalent Micron Technologies, Inc.
- 69988-0059-
  - 69988-0059-1- 1 BAG in 1 DRUM (69988-0059-1) / 10 POWDER in 1 BAG

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇