Elinzanetant for menopause-associated sleep disturbance: pooled analysis of two phase III studies

Objective This study aimed to evaluate the effects of elinzanetant on sleep in postmenopausal women with vasomotor symptoms (VMS), including by symptom burden.Method Pooled phase III OASIS-1 and OASIS-2 data included postmenopausal women aged 40–65 years experiencing ≥50 moderate-to-severe VMS/week, randomized to elinzanetant 120 mg (n = 399) or placebo (n = 397). Sleep disturbance was assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) 8b and the Insomnia Severity Index (ISI). Changes from baseline to week 12 were analyzed using mixed models for repeated measures.Results At week 12, elinzanetant showed greater reductions from baseline versus placebo in PROMIS SD SF 8b T-score (least squares [LS] mean difference: −4.9; 95% confidence interval [CI] − 6.0, −3.9; nominal p < 0.0001) and ISI (LS mean difference: −3.0; 95% CI −3.7, −2.2, nominal p < 0.0001). Larger reductions occurred in women with higher baseline insomnia and VMS frequency. Improvements were evident by week 1 (PROMIS SD SF 8b LS mean difference versus placebo: −4.7; 95% CI −5.7, −3.8; nominal p < 0.0001). By week 12, 67% of women on elinzanetant versus 47% on placebo were within the normal PROMIS range.Conclusion Elinzanetant produced rapid-onset improvements in sleep disturbance that were sustained at week 12, supporting its potential to treat menopause-associated sleep disturbance in women with VMS.