ZURZUVAE 20 mg/1
zuranolone · CAPSULE · Biogen MA Inc.
Zurzuvae (zuranolone) is an oral capsule medication used to treat postpartum depression in adults. It works by modulating gamma-aminobutyric acid receptors in the brain to help improve mood and symptoms associated with postpartum depression.
Key Facts
- Brand Name
- ZURZUVAE
- Generic Name
- zuranolone
- NDC Code (Product)
64406-029- Manufacturer
- Biogen MA Inc.
- Strength
- 20 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- NDA217369
- Drug Class
- Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- Marketing Start
- 10/31/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer with fat-containing food. ( 2.1 ) Recommended dosage is 50 mg orally once daily in the evening for 14 days. ( 2.1 ) Dosage may be reduced to 40 mg once daily if CNS depressant effects occur. ( 2.1 ) ZURZUVAE can be used alone or as an adjunct to oral antidepressant therapy. ( 2.1 ) Severe Hepatic Impairment: Recommended dosage is 30 mg orally once daily in the evening for 14 days. ( 2.3 , 8.6 ) Moderate or Severe Renal Impairment: Recommended dosage is 30 mg orally once daily in the evening for 14 days. ( 2.4 , 8.7 ) 2.1 Recommended Dosage The recommended dosage of ZURZUVAE is 50 mg taken orally once daily in the evening for 14 days. Administer ZURZUVAE with fat-containing food (e.g., 400 to 1,000 calories, 25% to 50% fat) [see Clinical Pharmacology ( 12.3 )] . If patients experience CNS depressant effects within the 14-day period, consider reducing the dosage to 40 mg once daily in the evening within the 14-day period. ZURZUVAE can be used alone or as an adjunct to oral antidepressant therapy. The safety and effectiveness of ZURZUVAE use beyond 14 days in a single treatment course have not been established. 2.2 Dosage Modifications for Concom…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 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 c…
Adverse Reactions
6 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 )] Most common adverse reactions (incidence ≥5% and greater than placebo) were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-844-987-9882 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ZURZUVAE for the treatment of postpartum depression (PPD) was evaluated in two placebo-controlled clinical studies in 347 women with PPD treated with 50 mg of ZURZUVAE (Study 1), or with another zuranolone capsule…
Frequently Asked Questions
What is ZURZUVAE used for?
Zurzuvae (zuranolone) is an oral capsule medication used to treat postpartum depression in adults. It works by modulating gamma-aminobutyric acid receptors in the brain to help improve mood and symptoms associated with postpartum depression.
Is ZURZUVAE a controlled substance?
Yes, ZURZUVAE is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for ZURZUVAE?
The generic name for ZURZUVAE is zuranolone. There are no other listed brand versions of zuranolone.
What is the NDC code for ZURZUVAE 20 mg/1?
The NDC (National Drug Code) for ZURZUVAE 20 mg/1 is 64406-029, listed by Biogen MA Inc..
Other ZURZUVAE Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)