John G Park1, Eric J Olson, Timothy I Morgenthaler. 1. Center for Sleep Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN 55905, USA. park.john@mayo.edu
Abstract
STUDY OBJECTIVE: To determine whether pretreatment with zaleplon immediately before CPAP titration improves 1-month CPAP adherence in subjects newly diagnosed with OSA. METHODS: Prospective, randomized, double-blinded, placebo-controlled trial of a single dose of zaleplon 10 mg or matching placebo at the start of CPAP titration during laboratory-based, split-night polysomnography (PSG). Baseline sleep symptoms were assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS). CPAP usage and change in symptom questionnaire responses were assessed at 1-month follow-up. RESULTS:One hundred thirty-fournewly diagnosed OSA patients undergoing their initial split-night PSG (49.8 ± 11.3 years old with an apnea-hypopnea index of 16.5 (7, 32) [median (interquartile range)] were randomized to zaleplon (n = 73) or placebo (n = 63). Complete follow-up data were available in 83 subjects (44 zaleplon group; 39 placebo group). CPAP was used for 6.5 (5, 7) h/day with zaleplon versus 6.5 (5, 8) h/ day with placebo (p = 0.64). Improvements in FOSQ and ESS scores did not differ between the two groups. CONCLUSION: A single dose of zaleplon at the start of a split-night CPAP titration does not result in superior CPAP adherence or improvement in symptoms at 1-month compared to placebo. Our data show that zaleplon is safe and is associated with shorter sleep latency during CPAP titration, but it does not translate into improved short-term CPAP adherence.
RCT Entities:
STUDY OBJECTIVE: To determine whether pretreatment with zaleplon immediately before CPAP titration improves 1-month CPAP adherence in subjects newly diagnosed with OSA. METHODS: Prospective, randomized, double-blinded, placebo-controlled trial of a single dose of zaleplon 10 mg or matching placebo at the start of CPAP titration during laboratory-based, split-night polysomnography (PSG). Baseline sleep symptoms were assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS). CPAP usage and change in symptom questionnaire responses were assessed at 1-month follow-up. RESULTS: One hundred thirty-four newly diagnosed OSA patients undergoing their initial split-night PSG (49.8 ± 11.3 years old with an apnea-hypopnea index of 16.5 (7, 32) [median (interquartile range)] were randomized to zaleplon (n = 73) or placebo (n = 63). Complete follow-up data were available in 83 subjects (44 zaleplon group; 39 placebo group). CPAP was used for 6.5 (5, 7) h/day with zaleplon versus 6.5 (5, 8) h/ day with placebo (p = 0.64). Improvements in FOSQ and ESS scores did not differ between the two groups. CONCLUSION: A single dose of zaleplon at the start of a split-night CPAP titration does not result in superior CPAP adherence or improvement in symptoms at 1-month compared to placebo. Our data show that zaleplon is safe and is associated with shorter sleep latency during CPAP titration, but it does not translate into improved short-term CPAP adherence.
Authors: T Hori; Y Sugita; E Koga; S Shirakawa; K Inoue; S Uchida; H Kuwahara; M Kousaka; T Kobayashi; Y Tsuji; M Terashima; K Fukuda; N Fukuda Journal: Psychiatry Clin Neurosci Date: 2001-06 Impact factor: 5.188
Authors: T E Weaver; A M Laizner; L K Evans; G Maislin; D K Chugh; K Lyon; P L Smith; A R Schwartz; S Redline; A I Pack; D F Dinges Journal: Sleep Date: 1997-10 Impact factor: 5.849
Authors: N B Kribbs; A I Pack; L R Kline; P L Smith; A R Schwartz; N M Schubert; S Redline; J N Henry; J E Getsy; D F Dinges Journal: Am Rev Respir Dis Date: 1993-04
Authors: Christopher L Drake; Ryan Day; David Hudgel; Yevgeniy Stefadu; Mary Parks; Mary Lou Syron; Thomas Roth Journal: Sleep Date: 2003-05-01 Impact factor: 5.849