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

Conditions studied

Insomnia, Hypertension

About this study

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).

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.

Primary outcomes

• Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring) (3 months)

Eligibility information

Study locations

• Academic Research Organization - Heart Institute (InCor), São Paulo, São Paulo 05403900 Brazil