Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
The clinical population targeted will be newly diagnosed patients with polysomnographically
 diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia.
 Outpatients who are also judged to be capable to follow the study procedures (consent,
 timelines, visits, questionnaires) and who do not have any concurrent disease that in the
 view of the investigator will interfere with participation in the trial to completion will be
 included. Approximately 160 subjects were recruited (80 per treatment arm) in the recent
 trial of eszopiclone. This size is expected to be able to discern an important difference of
 80 minutes per night. In the current clinical population newly prescribed CPAP at Mount Sinai
 Hospital, the average compliance after 4 weeks of initiation of nCPAP was 4:01 (SD 2:59)
 hours per night. To be able to discern a difference of at least 1 hour (60 minutes) in usage
 per night, including entirely non-adherent patients who do not use treatment at all as 'zero
 hour' users, would require randomization of 264 patients (132 per group).

 Our hypothesis for this study is that initial titration of CPAP treatment of OSA may be
 improved by initial prescription of a common hypnotic, zopiclone. To answer this question we
 intend to recruit 264 consecutive consenting subjects with OSA confirmed by a physician (ABSM
 or by a respirologist with extensive sleep medicine experience) with supportive
 polysomnography results who are willing to initiate long-term CPAP treatment.
Background: Obstructive sleep apnea (OSA) is a common sleep breathing disorder that is
 associated with serious complications. Continuous positive airway pressure (CPAP) is the
 treatment of choice for most patients but its use in the real world is limited by low patient
 adherence which may result in sub-optimal outcomes for some patients. A single hypnotic with
 low risk of adverse effects is a cost-effective intervention to augment the currently low
 adherence to CPAP, especially if only prescribed for a limited time. The hypnotic is generic
 zopiclone 3.75-7.5 mg at bedtime for up to 14 doses.

 The clinical population targeted will be newly expert physician-diagnosed patients
 polysomnographically supported OSA who are not currently taking hypnotics for concomitantly
 diagnosed insomnia. Outpatients who are also judged to be capable to follow the study
 procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent
 disease that in the view of the investigator will interfere with participation in the trial
 to completion will be included.
Inclusion Criteria:

 -  MD diagnosis of obstructive sleep apnea

 -  No previous use of CPAP

 -  No concurrent use of hypnotic medication

 Exclusion Criteria:

 -  Fatal comorbidities (i.e., life expectancy less than 6 months)

 -  Contraindications for CPAP use

 -  Pregnancy

 -  Liver Failure