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

Phase 4

Recruiting

• Conditions: Insomnia; Hypertension
• Interventions: Drug: Placebo; Drug: Eszopiclone 3 mg

• Registration Number: NCT07018557
• Lead Sponsor: University of Sao Paulo

Brief 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).

Detailed Description

We will consecutively evaluate the presence of insomnia in adult patients with hypertension under regular treatment recruited from the outpatient clinic at the Heart Institute (InCor).

The following exams will be made:

1. Definition of the presence of insomnia following the criteria from DSM V and severity by the insomnia severity index.

2. Evaluation of the Pittsburgh Sleep Quality Index.

3. Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.

4. Evaluation of anxiety disorder by the Generalized Anxiety Disorder (GAD-7)

5. Beck form for depression evaluation.

6. Detection of sleep apnea using a portable monitor (BiologixTM) Patients that fulfilled the inclusion criteria will be submitted to a 1-month run-in period before randomization with pill counting for improving medical adherence and defining baseline BP. Then patients with be randomized to sleep hygiene + eszopiclone or sleep hygiene + placebo for 3 months (double-blind study design). We will collect demographic and anthropometric data, as well as concomitant comorbidities, medications, standard BP measurements (office and ABPM) at baseline and after 3 -months.

The main hypothesis is that pharmacological treatment, as compared to placebo, will be able to improve insomnia in parallel to a significant decrease in 24-h ABPM (primary outcome). We will also evaluate absolute decrease of daytime and nighttime BP, % of 24-h, daytime, and nighttime BP control, % non-dipping BP, office BP, sleep quality and improvement in insomnia severity index scale as secondary outcomes. Exploratory analysis evaluating the effects of eszopiclone according to the type of insomnia (initial or sleep-onset insomnia, middle or maintenance insomnia and terminal or late insomnia). We also explored whether the results will be influenced by the presence of untreated sleep apnea.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-04
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + sleep hygiene	Placebo	Placebo pill (identical to the active treatment) + sleep counseling for improving insomnia
Eszopiclone + sleep hygiene	Eszopiclone 3 mg	Active treatment for insomnia + sleep counseling

Primary Outcome Measures

Name	Time	Method
Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)	3 months	To assess the impact of treatment of insomnia with eszopiclone on 24-h blood pressure by ABPM (mmHg).

Secondary Outcome Measures

Name	Time	Method
Efficacy of insomnia treatment on daytime and nighttime blood pressure (evaluated by Ambulatory blood pressure monitoring)	3 months	To assess the impact of treatment of insomnia with eszopiclone on daytime and nighttime blood pressure BP (mmHg).
Efficacy of insomnia treatment on 24-h, daytime, and nighttime BP control (evaluated by Ambulatory blood pressure monitoring)	3 months	To assess the impact of treatment of insomnia with eszopiclone on 24-h, daytime, and nighttime BP control (%).
Efficacy of insomnia treatment on non-dipping BP pattern (evaluated by Ambulatory blood pressure monitoring)	3 months	To assess the impact of treatment of insomnia with eszopiclone on non-dipping BP (%).
Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)	3 months	To assess the impact of treatment of insomnia with eszopiclone on office BP (mmHg).
Efficacy of insomnia treatment on sleep quality (evaluated by Pittsburgh Sleep Quality Index)	3 months	To assess the impact of treatment of insomnia with eszopiclone on sleep quality (absolute values).
Efficacy of insomnia treatment on insomnia severity (evaluated by insomnia severity index)	3 months	To assess the impact of treatment of insomnia with eszopiclone on insomnia severity (absolute values).

Trial Locations

Locations (1)

Academic Research Organization - Heart Institute (InCor); 🇧🇷 São Paulo, SP, Brazil