From the FDA Drug Label
ZURZUVAE contains zuranolone, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator. The chemical name is 1-[(3α, 5β)-3-hydroxy-3-methyl-20- oxo-19-norpregnan-21-yl]-1H-pyrazole-4-carbonitrile and it has the following chemical structure: The molecular formula of zuranolone is C25H35N3O2 and the relative molecular mass is 409. 57. Zuranolone is a white to off-white, non-hygroscopic, crystalline solid.
Zuranolone is a neuroactive steroid that acts as a GABA A receptor positive modulator.
- The chemical formula of zuranolone is C25H35N3O2.
- The molecular mass of zuranolone is 409.57.
- Zuranolone is available in 20 mg, 25 mg, and 30 mg capsules for oral administration 1 1.
From the Research
Zuranolone is a recommended treatment option for postpartum depression and major depressive disorder, given its rapid efficacy and relatively favorable safety profile, as demonstrated in recent studies 2, 3, 4.
Key Points
- Zuranolone is a neuroactive steroid that acts as a positive allosteric modulator of GABA-A receptors, enhancing the inhibitory effects of GABA in the brain to reduce depressive symptoms.
- The medication is taken as a 50mg pill once daily for 14 days, providing sustained benefits for many patients without the need for continuous daily use.
- Common side effects include drowsiness, dizziness, and sedation, which can be mitigated by taking the medication at bedtime and avoiding alcohol and other CNS depressants.
- Patients should be cautious when operating machinery or driving until they understand how the medication affects them.
- While effective, zuranolone is expensive, with a cost of approximately $15,000 per treatment course, which may limit accessibility for some patients due to potential insurance coverage issues.
Efficacy and Safety
- Studies have shown that zuranolone significantly decreases Hamilton Rating Scale for Depression (HAM-D) scores in patients with postpartum depression and major depressive disorder, with rapid improvement observed within days 2, 3.
- The medication has also been associated with a higher response rate and remission rate compared to placebo, although the long-term effects of zuranolone require further evaluation 2, 3.
- Adverse events such as somnolence, dizziness, and sedation are common, but the medication is generally well-tolerated, with no significant increase in serious adverse events or discontinuation due to adverse events 2, 3, 4.
Clinical Considerations
- Zuranolone may be a useful treatment option for patients with postpartum depression or major depressive disorder who require rapid relief from symptoms or have not responded to traditional antidepressants.
- Healthcare providers should carefully evaluate the potential benefits and risks of zuranolone for each patient, considering factors such as medical history, concomitant medications, and insurance coverage.
- Further research is needed to fully understand the long-term efficacy and safety of zuranolone, as well as its potential uses in other psychiatric conditions.