Effect of Zuranolone on Concurrent Anxiety and Insomnia Symptoms in Women With Postpartum Depression

Objective: Concurrent anxiety and/or insomnia symptoms in women with postpartum depression (PPD) are common and associated with more severe PPD. The effects of zuranolone on concurrent anxiety and/or insomnia symptoms and on patient-perceived functional health in women with PPD in the ROBIN study are reported. Methods: The phase 3, double-blind, randomized, placebocontrolled trial (conducted January 2017-December 2018) included women aged 18-45 years, <= 6 months postpartum, with PPD (onset of DSM-5-defined major depressive episode in the third trimester or <= 4 weeks postpartum) and baseline 17-item Hamilton Depression Rating Scale (HDRS-17) total score >= 26. Women were randomized 1:1 to once-daily oral zuranolone 30 mg (n = 77) or placebo (n = 76) for 14 days with follow-up through day 45. Concurrent remission of depressive and anxiety symptoms (Hamilton Anxiety Rating Scale total score <= 7 plus HDRS-17 total score <= 7 or Montgomery-Asberg Depression Rating Scale total score <= 10), improvement in insomnia symptoms, patient-perceived functional health, and treatment effect sizes described by number needed to treat (NNT) were assessed. Analyses were exploratory; P values are nominal. Conclusions: Zuranolone was associated with concurrent improvements in depressive and anxiety symptoms, with beneficial effects on insomnia symptoms and patient-perceived functional health in adults with PPD.