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RECRUITING
NCT07018557
PHASE4

Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)

Sponsor: University of Sao Paulo

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

Placebo

Placebo pills identical to the active comparator.

Locations (1)

Academic Research Organization - Heart Institute (InCor)

São Paulo, São Paulo, Brazil