drugset / Trial / NCT05593653

Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia

NCT05593653 ↗

Phase 4 Completed 31 enrolled Brigham and Women's Hospital
RandomizedCrossoverQuadruple-blindTreatment

Summary

The aim of this study is to determine if suvorexant can help treat the severity of insomnia and improve metabolic health in midlife women who had both insomnia and indicators of metabolic syndrome.

Timeline

Start
2023-01-06
Primary completion
2025-10-24
Completion
2025-10-24

Outcome

Met primary endpoint

registry MEAN Suvorexant: Change from Baseline at 4 weeks: -5.8 (Standard Deviation 4.9) units on a scale NCT05593653 ↗

registry analysis (superiority test); Suvorexant vs Placebo; p = 0.04; Mixed Models Analysis NCT05593653 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Suvorexant Small molecule 20 mg Oral