Zuranolone in postpartum depression: a profile of its use in the USA

Zuranolone (ZURZUVAE (R)), an orally bioavailable neuroactive steroid and a selective, positive, allosteric modulator of both synaptic and extrasynaptic gamma aminobutyric acid A (GABAA) receptors, may represent a valuable treatment option for adults with postpartum depression (PPD). Zuranolone is the first oral drug to be approved for the treatment of PPD in adults in the USA. In two randomized, double-blind, placebo-controlled, phase 3 trials, a 14-day treatment course of zuranolone 50 mg (recommended dose) or 30 mg (approximately equivalent to 40 mg of approved formulation of zuranolone) once daily in the evening with food demonstrated rapid, sustained, and clinically meaningful improvements in depressive symptoms compared with placebo in adults with PPD. Improvements in symptoms of anxiety and insomnia along with beneficial effects on patient-reported functional health and well-being were observed in patients treated with zuranolone. Zuranolone was generally well tolerated. Most treatment-emergent adverse events reported in clinical trials were mild to moderate in severity, with somnolence being the most common adverse event. Zuranolone carries a boxed warning regarding driving impairment for >= 12 h after each dose due to its CNS depressant effects. Postpartum depression (PPD), a common mood disorder experienced during pregnancy or after childbirth, can have a negative impact on the well-being of the mother, their partner, and the child. There is evidence to support the role of neuroactive steroids and gamma aminobutyric acid (GABA) in the pathophysiology of PPD. Zuranolone (ZURZUVAE (R)), a neuroactive steroid that positively modulates GABAA receptors, is the first oral medication to be approved for the treatment of PPD in adults in the USA. When administered once daily in the evening with fat-containing food for 14 days in clinical trials, zuranolone significantly improved depressive symptoms compared with placebo in adults with PPD. Symptoms of anxiety and insomnia were also improved in patients treated with zuranolone. Patients treated with zuranolone reported improvements in functional health and well-being. Zuranolone was generally well tolerated. Most treatment-emergent adverse events reported in clinical trials were mild to moderate in severity. The medication can cause drowsiness and confusion, which restricts patients from driving for >= 12 h after each dose. Zuranolone represents a valuable treatment option for adults with PPD.