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A phase 1 double‐blind, placebo‐controlled study of zuranolone (SAGE‐217) in a phase advance model of insomnia in healthy adults
Author(s) -
Bullock Amy,
GunduzBruce Handan,
Zammit Gary K.,
Qin Min,
Li Haihong,
Sankoh Abdul J.,
Silber Christopher,
Kanes Stephen J.,
Jonas Jeffrey,
Doherty James
Publication year - 2022
Publication title -
human psychopharmacology: clinical and experimental
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.461
H-Index - 78
eISSN - 1099-1077
pISSN - 0885-6222
DOI - 10.1002/hup.2806
Subject(s) - placebo , tolerability , insomnia , polysomnography , sleep onset , medicine , somnolence , anesthesia , crossover study , adverse effect , pharmacology , alternative medicine , apnea , pathology
Abstract Objective To evaluate single zuranolone (SAGE‐217) 30 or 45 mg doses in a 5‐h phase advance insomnia model. Methods In this double‐blind, three‐way crossover study, healthy adults received placebo ( n = 41), zuranolone 30 mg ( n = 44), and zuranolone 45 mg ( n = 42) across three treatment periods. Sleep was assessed by polysomnography and a postsleep questionnaire. Next‐day residual effects and safety/tolerability were evaluated. Results Compared with placebo, zuranolone resulted in significant improvements in median sleep efficiency (30 mg, 84.6%; 45 mg, 87.6%; placebo, 72.9%; p < 0.001 for both doses), wake after sleep onset (WASO; 30 mg, 55.0 min; 45 mg, 42.5 min; placebo, 113.0 min; p < 0.001 for both doses), duration of awakenings (30 mg, 4.2 min, p < 0.001; 45 mg, 3.7 min, p = 0.001; placebo, 7.4 min), and total sleep time (TST; 30 mg, 406.3 min; 45 mg, 420.3 min; placebo, 350.0 min; p < 0.001 for both doses). Subjective endpoints (WASO, TST, sleep latency, sleep quality) also improved relative to placebo. Zuranolone was generally well tolerated, and the most common adverse events (≥2 participants, any period) were headache and fatigue. Conclusion Zuranolone improved sleep measures versus placebo in a phase advance model of insomnia in healthy adults, supporting future studies in patients with insomnia disorder.