Zuranolone (1 brand name, 1 dosage form, 1 route)
Available dosage forms: CAPSULE.
Routes of administration: ORAL.
Brand Names
- ZURZUVAE
Boxed Warning
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)] .
Indications and Usage
ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults.
Contraindications
None.
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities [see Warnings and Precautions (5.1)] Central Nervous System Depressant Effects [see Warnings and Precautions (5.2)] Suicidal Thoughts and Behavior [see Warnings and Precautions (5.3)]
Drug Interactions
Table 4 displays clinically important drug interactions with ZURZUVAE. Table 4. Clinically Important Drug Interactions with ZURZUVAE CNS Depressant Drugs and Alcohol Clinical Impact Due to additive pharmacological effects, the concomitant use of CNS depressant drugs, including alcohol, may increase impairment of psychomotor performance or CNS depressant effects. Management If use with another CNS depressant is unavoidable, consider dosage reduction. Caution should be used when ZURZUVAE is administered in combination with other CNS drugs or alcohol [see Warnings and Precautions (5.2)]. Strong CYP3A4 Inhibitors Clinical Impact Concomitant use of ZURZUVAE with a strong CYP3A4 inhibitor increases the exposure of zuranolone [see Clinical Pharmacology (12.3)], which may increase the risk of ZURZUVAE-associated adverse reactions. Management Reduce the ZURZUVAE dosage when used with a strong CYP3A4 inhibitor [see Dosage and Administration (2.3)]. CYP3A4 Inducers Clinical Impact Concomitant use of ZURZUVAE with a CYP3A4 inducer decreases the exposure of zuranolone [see Clinical Pharmacology (12.3)], which may reduce the efficacy of ZURZUVAE. Management Avoid concomitant use of ZURZUVAE with CYP3A4 inducers [see Dosage and Administration (2.3)].
Mechanism of Action
The mechanism of action of zuranolone in the treatment of PPD is not fully understood but is thought to be related to its positive allosteric modulation of GABAA receptors.
Overdosage
There was a case of intentional overdose with ZURZUVAE reported during premarketing clinical trials. The patient took 330 mg (6.5 times the maximum recommended dose) of ZURZUVAE and was reported to be in an altered state of consciousness. The event resolved the next day, following treatment with intravenous fluids. Overdosage with ZURZUVAE may result in excessive CNS depressant effects such as somnolence and disturbance in consciousness. There is no specific antidote for ZURZUVAE overdosage. Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.