Testing Eszopiclone's Effect on Blood Pressure in People With Insomnia
Tests eszopiclone against placebo in adults with insomnia and high blood pressure.
Plain-language title generated from the registry record
Registry title: Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 75 years old?
Source: NCT07018557, who can take part
Where in Brazil
- Academic Research Organization - Heart Institute (InCor)São Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sao Paulo
- Trial code
- NCT07018557
- Record updated
- 12 June 2025
- Original description
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).Read full original descriptionShow less
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
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).
Inclusion: 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: Use of benzodiazepines or "Z" drugs; Prior stroke; History of severe chronic obstructive pulmonary disease (COPD); Generalized anxiety disorder (GAD-7 >14 points) and severe depression (Beck); Severe liver disease; Advanced chronic kidney disease 4 or 5 (glomerular filtration rate <30ml/min/1.73m2); Patient with type 1 diabetes; History of active cancer; Heart failure (ejection fraction <40% on echocardiogram); Patient with decompensated type 2 diabetes (Glycated hemoglobin >10%); Night workers; Alcohol abuse; Patient who is on loop diuretics; Urinuria Incontinence; Prostatism; Pregnancy; Complex sleep behaviors, suicidal behavior.