Clinical trial: esomeprazole for moderate-to-severe nighttime heartburn and gastro-oesophageal reflux disease-related sleep disturbances

Aliment Pharmacol Ther. 2010 Jul;32(2):182-90. doi: 10.1111/j.1365-2036.2010.04339.x. Epub 2010 Apr 29.


Background: Nighttime heartburn, common among patients with gastro-oesophageal reflux disease (GERD), is associated with substantial clinical effects. GERD-related sleep disturbances are underappreciated and undertreated.

Aim: To evaluate the efficacy of esomeprazole on GERD-related nighttime heartburn and associated sleep disturbances.

Methods: In this multicentre, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances (endoscopies not required) received esomeprazole 20 mg or placebo each morning for 4 weeks. Heartburn symptoms and GERD-related sleep disturbances were evaluated using the validated Pittsburgh Sleep Quality Index and validated Work Productivity and Activity Impairment Questionnaire.

Results: The analysis included 262 patients (esomeprazole, n = 137; placebo, n = 125). Significantly more patients receiving esomeprazole achieved nighttime heartburn relief (primary end point) than those receiving placebo (34.3% vs. 10.4%; P < 0.0001). Secondary end points such as relief of GERD-related sleep disturbances (P = 0.006), days without GERD-related sleep disturbances (P = 0.0003) and complete resolution of sleep disturbances (P < 0.0001) favoured esomeprazole over placebo. Sleep quality, work productivity and regular daily activities also improved significantly with esomeprazole vs. placebo.

Conclusions: Esomeprazole 20 mg is effective for patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances, improving heartburn symptoms, sleep quality, work productivity and functionality.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Ulcer Agents / therapeutic use*
  • Double-Blind Method
  • Esomeprazole / therapeutic use*
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Heartburn / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Sleep Wake Disorders / drug therapy*
  • Surveys and Questionnaires
  • Treatment Outcome
  • Young Adult


  • Anti-Ulcer Agents
  • Esomeprazole