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Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Sponsor: University of Sao Paulo
Summary
Insomnia is a common sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite appropriate opportunities for getting sleep. Growing evidence has associated insomnia with prevalent and incidence of hypertension. However, the impact of the pharmacologic treatment of insomnia on office blood pressure (BP) and 24-h ambulatory BP monitoring (ABPM) in unclear. Therefore, the aim of this study is to evaluate the impact of eszopiclone, a non-benzodiazepine hypnotic that binds to certain subunits of the gamma-aminobutyric acid type A receptors GABA-A (such as α1, α3, and α5) promoting relaxation and sleep. Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-06-04
Completion Date
2026-12-31
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
Eszopiclone 3 mg
Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).
Placebo
Placebo pills identical to the active comparator.
Locations (1)
Academic Research Organization - Heart Institute (InCor)
São Paulo, São Paulo, Brazil