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

Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (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.

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.