Important Safety Information
Warning: ZURZUVAE can affect the ability to perform tasks that require alertness, such as driving or using machinery, due to its sedative effects. It's advised that patients do not engage in such activities until at least 12 hours after taking the medication as they may not accurately judge their level of impairment.
How to Use
- Take ZURZUVAE with a meal that includes fat.
- The standard dosage is 50 mg once a day in the evening, continuing for 14 days.
- If side effects related to the central nervous system (CNS) occur, the dosage may be adjusted to 40 mg.
- ZURZUVAE can be taken with or without other oral antidepressant treatments.
- For patients with severe liver issues or moderate to severe kidney issues, the dosage should be reduced to 30 mg.
Forms and Strengths
ZURZUVAE is available in capsule form in 20 mg, 25 mg, and 30 mg strengths.
No Known Contraindications
There are no identified contraindications for ZURZUVAE at this time.
Warnings and Precautions
- Watch for CNS depressant effects like sleepiness and confusion. Dosage adjustments or discontinuation may be necessary if these occur.
- Monitor for worsening PPD symptoms or the emergence of suicidal thoughts and actions, and adjust treatment accordingly.
- ZURZUVAE may harm an unborn baby; it's crucial for women who are pregnant or of childbearing potential to be aware of this risk and use effective birth control during and for one week after treatment.
The most frequently reported side effects, which are more common than with a placebo, include sleepiness, dizziness, diarrhea, tiredness, the common cold, and urinary tract infections.
Reporting Side Effects
Adverse reactions can be reported to Sage Therapeutics, Inc. or the FDA.
- Taking ZURZUVAE with other CNS depressants may increase the impairment of motor performance or sedative effects.
- Strong inhibitors of the enzyme CYP3A4 can heighten the risk of adverse reactions, necessitating a dosage reduction to 30 mg.
- Medications that induce CYP3A4 might reduce ZURZUVAE's effectiveness, and their combined use should be avoided.
August 04, 2023, marked a significant milestone in the field of mental health as the U.S. Food and Drug Administration (FDA) gave the green light to Zurzuvae (zuranolone), pioneering the first oral treatment designed specifically for postpartum depression (PPD) in adults. Historically managed with IV injections in medical facilities, this breakthrough avails a more accessible treatment for those suffering from PPD, which can manifest as a major depressive episode following childbirth or even during the later stages of pregnancy.
Postpartum depression is recognized as a critical mental health issue that can lead to profound feelings of sadness, guilt, and can pose a severe threat to the well-being of new mothers and their children. Zurzuvae's effectiveness in alleviating the symptoms of PPD was backed by two robust, double-blind studies involving women who met the Diagnostic and Statistical Manual of Mental Disorders' criteria for a major depressive episode with onset at the third trimester or within four weeks post-delivery. These studies revealed that patients administered with Zurzuvae showcased a substantial improvement in depressive symptoms compared to placebo, with the benefits persisting for weeks following the completion of treatment.
Warnings and precautions
Despite its effectiveness, Zurzuvae carries a boxed warning regarding its potential to impair one's ability to undertake tasks requiring full cognitive function, such as driving. Due to possible challenges in self-evaluating these impairments, it is recommended that patients refrain from such activities for at least 12 hours post-dosage.
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The following are antidepressant subclasses and drugs
Contributors: Prab R. Tumpati, MD