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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Placebo: Placebo pills identical to the active comparator.

Study 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

Primary outcome measure(s)

• 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).

Trial sites (1)

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