The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome

• Arousal Threshold [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ] [ Designated as safety issue: No ]
  quantified using an epiglottic pressure transducer in CmH2O
• Other measures of sleep apnea severity as determined during the polysomnogram [ Time Frame: 8 hour In-Laboratory Polysomnogram (PSG) ] [ Designated as safety issue: No ]
  e.g. nadir SaO2, total sleep time, event duration

The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).

Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. The current primary treatment e.g. Continuous positive airway pressure (CPAP) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. Secondary treatments such as oral appliances to advance the mandible or surgical procedures to enlarge the airway are commonly appealing to the patient. However, these approaches have only modest success in reducing apnea frequency to an acceptable level. Thus, finding tolerable and effective therapy for sleep apnea remains an important objective.

The causes of sleep apnea vary between patients. Targeted therapy according to the underlying causes of sleep apnea in individual patients is likely to be most effective. However, current therapeutic options for sleep apnea are quite limited. The purpose of this physiological research study is to determine if taking eszopiclone (Lunesta)changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (the arousal threshold) and if administration of the sedative medication eszopiclone (Lunesta) to certain sleep apnea patients (those with a low arousal threshold ie wake up easily) would be beneficial.

• Drug: Eszopiclone
  3mg tablet once prior to sleep
  Other Name: Lunesta
• Drug: Placebo
  1 placebo capsule prior to sleep

• Active Comparator: Eszopiclone
  Intervention: Drug: Eszopiclone
• Placebo Comparator: Sugar Pill
  Intervention: Drug: Placebo

Inclusion Criteria:

• 18-64 years old
• Untreated obstructive sleep apnea

Exclusion Criteria:

• Nadir SaO2 <70% on a baseline PSG
• Medications known to affect either sleep, breathing or muscle activity
• Major co-morbidities apart from sleep apnea
• Allergy to lidocaine, oxymetazoline HCl, or eszopiclone
• Women who are pregnant

• Sunovion
• National Institutes of Health (NIH)