NCT05593653

Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this research study is to investigate if suvorexant can help treat the severity of insomnia (a chronic sleep disorder) in midlife women and to learn whether improvement in insomnia symptoms is linked with improvement in metabolic health. This is a double-blind, randomized placebo-controlled crossover trial. Study procedures are conducted over a 14-week period (2-week screening period, 4-week treatment period \[Block 1\], 4-week washout, and 4-week treatment period \[Block 2\]). During each treatment block, participants take a daily pill - during one block, they take suvorexant and during the other block, they take a placebo (randomized to the order).

Conditions

• Insomnia
• Metabolic Health
• Menopause

Interventions

Type	Name	Description
DRUG	Suvorexant	20mg taken at bedtime for 4 weeks
DRUG	Placebo	placebo taken at bedtime for 4 weeks

Timeline

• Start date: 2023-01-06
• Primary completion: 2025-10-24
• Completion: 2025-10-24
• First posted: 2022-10-25
• Last updated: 2026-04-16
• Results posted: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study