Effects of a Short Course of Eszopiclone on Continuous Positive Airway Pressure Adherence

doi:10.1059/0003-4819-151-10-200911170-00006

Effects of a Short Course of Eszopiclone on Continuous Positive Airway Pressure Adherence

A Randomized Trial

Christopher J. Lettieri, MD;
Anita A. Shah, DO;
Aaron B. Holley, MD;
William F. Kelly, MD;
Audrey S. Chang, PhD;
Stuart A. Roop, MD; and
for the CPAP ASAP (CPAP Promotion and Prognosis—The Army Sleep Apnea Program) Trial

From the Walter Reed Army Medical Center, Washington, DC, and the Uniformed Services University of the Health Sciences, Bethesda, Maryland.

Abstract

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 apnea–hypopnea index, 36.9 events/h [SD, 23]) with newly diagnosed obstructive sleep apnea initiating CPAP.

Intervention: Eszopiclone, 3 mg (n = 76), or matching placebo (n = 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%; P = 0.003), 1.3 more hours per night for all nights (CI, 0.4 to 2.2 hours; P = 0.005), and 1.1 more hours per night of CPAP use (CI, 0.2 to 2.1 hours; P = 0.019). The hazard ratio for discontinuation of CPAP was 1.90 (CI, 1.1 to 3.4; P = 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.

Article and Author Information

Disclaimer: The views expressed in this article are solely the authors and do not reflect those of the government nor constitute official policy of the United States Army or Department of Defense.
Acknowledgment: The authors thank the participants for their involvement in the trial. They also thank research assistant Rachel Massey and respiratory therapist Sandra Clay for their valuable contributions to the study.
Grant Support: By Sepracor to the Henry M. Jackson Foundation for the Advancement of Military Medicine.
Potential Conflicts of Interest: None disclosed.
Reproducible Research Statement: Study protocol: Available online at ClinicalTrials.gov or from Dr. Lettieri (christopher.lettieri{at}us.army.mil). Statistical code: Available from Dr. Holley (aaron.holley{at}amedd.army.mil). Data set: Available from Dr. Lettieri.
Requests for Single Reprints: Christopher J. Lettieri, MD, Pulmonary, Critical Care and Sleep Medicine, Walter Reed Army Medical Center, 6900 Georgia Avenue, Northwest, Washington, DC 20307; e-mail, christopher.lettieri{at}us.army.mil.
Current Author Addresses: Drs. Lettieri, Shah, Holley, Chang, and Roop: Pulmonary, Critical Care and Sleep Medicine, Walter Reed Medical Center, 6900 Georgia Avenue Northwest, Washington, DC 20307.
Dr. Kelly: Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814.
Author Contributions: Conception and design: C.J. Lettieri, A.A. Shah, S.A. Roop.
Analysis and interpretation of the data: C.J. Lettieri, A.A. Shah, A.B. Holley, W.F. Kelly, A.S. Chang, S.A. Roop.
Drafting of the article: C.J. Lettieri, A.A. Shah, A.B. Holley, W.F. Kelly.
Critical revision of the article for important intellectual content: C.J. Lettieri, A.A. Shah, A.B. Holley, A.S. Chang, S.A. Roop.
Final approval of the article: C.J. Lettieri, A.A. Shah, A.B. Holley, W.F. Kelly, S.A. Roop.
Provision of study materials or patients: C.J. Lettieri, A.B. Holley, W.F. Kelly.
Statistical expertise: A.B. Holley, A.S. Chang.
Obtaining of funding: C.J. Lettieri.
Administrative, technical, or logistic support: C.J. Lettieri, W.F. Kelly.
Collection and assembly of data: C.J. Lettieri, A.A. Shah, W.F. Kelly, S.A. Roop.