PURPOSE:Continuous positive airway pressure (CPAP) is very effective in eliminating the obstructive breathing events in patients with obstructive sleep apnea syndrome, but CPAP compliance only ranges between 29 –89%. Heated humidity, intensive education, and close follow-up have shown limited success in improving compliance. Improved sleep efficiency during the initial CPAP titration is reported to correlate with improved compliance. We hypothesized that CPAP compliance would improve by administering zaleplon, a short-acting hypnotic, to improve sleep efficiency during CPAP titration.
METHODS:This was an IRB approved, randomized, double-blinded, controlled study. After obtaining consent, subjects were randomized to zaleplon 10 mg or placebo at the time of CPAP titration. Compliance, the primary endpoint, was determined by device download at 46 ± 4.8 days follow-up. Secondary enpoints included sleep efficiency and the change in the functional outcomes of sleep questionnaire (FOSQ) scores before and after treatment. Correlations between compliance, FOSQ, and CPAP-titration sleep efficiency were also calculated.
RESULTS:176 eligible subjects were enrolled. Ultimately, 61 subjects were randomized to placebo and 73 subjects to zaleplon. The two groups were similar with respect to demographics, Epworth Sleepiness Scores, initial FOSQ scores, and diagnostic polysomnographic results. Compared with placebo, sleep efficiency, initial sleep latency, and percent slow wave sleep were all increased in the zaleplon group (p < 0.04), while REM was decreased (p = 0.001). While there was an absolute 25 minutes improved daily compliance in the zaleplon group, this did not reach statistical significance (p = 0.16). Also, there was no difference in follow-up FOSQ scores. There was no significant correlation between sleep efficiency during CPAP titration and compliance in the group as a whole (p=0.21), or in either group alone (p > 0.3).
CONCLUSION:Zaleplon acutely improved sleep efficiency during CPAP titration, but improvement in CPAP compliance was not statistically significant.
CLINICAL IMPLICATIONS:A single dose of zaleplon during CPAP titration enhances sleep efficiency and may allow a more thorough titration, but may not by itself improve long-term compliance.
DISCLOSURE:John Park, No Financial Disclosure Information; No Product/Research Disclosure Information