Background: Adherence to short-term continuous positive airway pressure (CPAP) may predict long-term use. Unfortunately, initial CPAP intolerance may lead to poor adherence or abandonment of therapy.
Objective: To determine whether a short course of eszopiclone at the onset of therapy improves long-term CPAP adherence more than placebo in adults with obstructive sleep apnea.
Design: Parallel randomized, placebo-controlled trial from March 2007 to December 2008. Randomization, maintained and concealed centrally by pharmacy personnel, was computer-generated using fixed blocks of 10. Referring physicians, investigators, and patients were blinded to the treatment assignment until after the final data were collected. (ClinicalTrials.gov registration number: NCT00612157)
Setting: Academic sleep disorder center.
Patients: 160 adults (mean age, 45.7 years [SD, 7.3]; mean apneaâ€“hypopnea index, 36.9 events/h [SD, 23]) with newly diagnosed obstructive sleep apnea initiating CPAP.
Intervention: Eszopiclone, 3 mg (nÂ = 76), or matching placebo (nÂ = 78) for the first 14 nights of CPAP.
Measurements: Use of CPAP was measured weekly for 24 weeks. Adherence to CPAP (primary outcome) and the rate of CPAP discontinuation and improvements in symptoms (secondary outcomes) were compared. Follow-up at 1, 3, and 6 months was completed by 150, 136, and 120 patients, respectively.
Results: Patients in the eszopiclone group used CPAP for 20.8% more nights (95% CI, 7.2% to 34.4%; PÂ = 0.003), 1.3 more hours per night for all nights (CI, 0.4 to 2.2 hours; PÂ = 0.005), and 1.1 more hours per night of CPAP use (CI, 0.2 to 2.1 hours; PÂ = 0.019). The hazard ratio for discontinuation of CPAP was 1.90 (CI, 1.1 to 3.4; PÂ = 0.033) times higher in the placebo group. Side effects were reported in 7.1% of patients and did not differ between groups.
Limitations: Patients had severe obstructive sleep apnea treated at a specialized sleep center with frequent follow-up; results may not be generalizable to different settings. Patients' tolerance to CPAP and their reasons for discontinuation were not assessed.
Conclusion: Compared with placebo, a short course of eszopiclone during the first 2 weeks of CPAP improved adherence and led to fewer patients discontinuing therapy.
Primary Funding Source: Sepracor.