Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
University of Sao Paulo
150 participants
Jun 4, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- Adults (30 to 75 years-old)
- BMI \<40Kg/m2;
- Availability to participate
- History of HBP under regular treatment (systolic pressure between 130-160 and diastolic pressure between 80-100 mmHg).
Exclusion Criteria17
- Use of benzodiazepines or "Z" drugs;
- Night workers;
- History of severe chronic obstructive pulmonary disease (COPD);
- Heart failure (ejection fraction \<40% on echocardiogram);
- Prior stroke;
- Generalized anxiety disorder (GAD-7 \>14 points) and severe depression (Beck);
- Severe liver disease;
- Alcohol abuse;
- Advanced chronic kidney disease 4 or 5 (glomerular filtration rate \<30ml/min/1.73m2);
- Patient who is on loop diuretics;
- Patient with type 1 diabetes;
- Patient with decompensated type 2 diabetes (Glycated hemoglobin \>10%);
- Urinuria Incontinence;
- Prostatism;
- History of active cancer;
- Pregnancy;
- Complex sleep behaviors, suicidal behavior.
Interventions
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 pills identical to the active comparator.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07018557