Eszopiclone for lowering blood pressure in adults with insomnia and high blood pressure

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

This study tests whether eszopiclone can improve sleep and lower 24-hour ambulatory blood pressure in adults aged 30–75 who have insomnia and treated hypertension.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 30 Years to 75 Years
• Sex: All
• Sponsor: University of Sao Paulo (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07018557 on ClinicalTrials.gov

What this trial studies

Adults with treated hypertension will be screened for insomnia and undergo baseline questionnaires and portable sleep apnea monitoring. After a one‑month run‑in period to confirm adherence and baseline blood pressure, eligible participants will be randomized in a double‑blind fashion to sleep hygiene plus eszopiclone 3 mg or sleep hygiene plus placebo for three months. The primary outcome is change in 24‑hour ambulatory blood pressure, with secondary outcomes including daytime/nighttime BP changes, non‑dipping status, office BP, and multiple validated sleep and mood scales. Demographic, anthropometric, comorbidity, and medication data will also be collected at baseline and after three months.

Who should consider this trial

Good fit: Adults 30–75 years old with treated high blood pressure (systolic 130–160 mmHg, diastolic 80–100 mmHg), BMI <40 kg/m2, and insomnia who can attend clinic visits and are not using benzodiazepines or 'Z' drugs are ideal candidates.

Not a fit: Patients with severe COPD, heart failure with reduced ejection fraction, prior stroke, severe psychiatric disorders, advanced kidney disease, decompensated diabetes, active cancer, pregnancy, current benzodiazepine/'Z' drug use, or shift work are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer a way to improve sleep and modestly reduce 24‑hour blood pressure in patients with insomnia and hypertension.

How similar studies have performed: Observational studies link insomnia to higher blood pressure, but randomized double‑blind trials testing hypnotic medications like eszopiclone on 24‑hour ambulatory blood pressure are limited, so this approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

São Paulo, São Paulo

• Academic Research Organization - Heart Institute (InCor) — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: LUCIANO F DRAGER, MD, PhD

Conditions Insomnia; Hypertension; Blood Pressure; Treatment