Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.

To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.

This is a prospective, randomized, double-blind parallel group study comparing the effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.

• Gastroesophageal Reflux Disease
• Chronic Insomnia

• Drug: Rozerem (ramelteon)
  dosage= take 1 tablet(8 MG) 20 min. before bedtime
  Other Names:

  • Rozerem
  • ramelteon
• Drug: placebo
  Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
  Other Names:

  • placebo
  • sugar pill

• Active Comparator: Rozerem
  Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
  Intervention: Drug: Rozerem (ramelteon)
• Placebo Comparator: placebo
  Comparing the effect of Rozerem vs. placebo on GERD symptomatology
  Intervention: Drug: placebo

Inclusion Criteria:

• Stop H2 blockers 72 hrs prior to starting study
• Stop PPI - 3 weeks prior to staring study
• Heartburn 3+ times a week
• Insomnia 3+ times a week for 3 months
• Erosive esophagitis or Abnormal pH test

Exclusion Criteria:

• On PPI or H2 blocker & not willing to get off
• Normal EGD (upper endoscopy) w/ normal pH test
• Upper Endoscopy(EGD)with erosive esophagitis(EE)- (LA C&D) LA=Los Angeles criteria. Grades include A-D
• Previous gastrointestinal Surgery
• HX of Diabetes/neuropathy
• HX of seizures
• Known psychological abnormalities(depression,anxiety...)
• Clinically Significant Underlying co morbidity
• Narcotic medications(pain meds)
• Regularly taking sleeping medications (2 week wash-out allowed)
• Taking medications that alter sleep-Psychotropic's, antihistamines, Narcotics and Benzodiazepines Sleep Apnea or other sleep disorders-PLM, RLS etc.