Eszopiclone improves overnight polysomnography and continuous positive airway pressure titration: a prospective, randomized, placebo-controlled trial (original) (raw)
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Sleep Medicine, 2007
Objective: To evaluate the effects of eszopiclone on measures of respiration and sleep using polysomnography in patients with mild to moderate obstructive sleep apnea syndrome (OSAS). Methods: This double-blind, randomized crossover study included patients (35-64 years) with mild-to-moderate OSAS [apnea and hypopnea index (AHI) range P10 and 640]. Patients received either eszopiclone 3 mg or placebo for two consecutive nights, with a 5-7 day washout between treatments. Continuous positive airway pressure (CPAP) was not allowed on nights in the sleep laboratory. Results: The primary endpoint, mean total AHI, was not significantly different from placebo (16.5 with placebo and 16.7 with eszopiclone; 90% confidence interval (CI) À1.7, 1.9). No significant differences in total arousals, respiratory arousals, duration of apnea and hypopnea episodes, or oxygen saturation were noted. Significant differences in spontaneous arousals (13.6 versus 11.4 for placebo and eszopiclone, respectively; 90% CI À3.7, À0.7), sleep efficiency (85.1% and 88.4%; p = 0.0075), wake time after sleep onset (61.8 and 48.1 min; p = 0.0125), and wake time during sleep (55.9 and 43.2 min; p = 0.013) were noted after eszopiclone treatment. Eszopiclone was well tolerated. Conclusions: In this pilot study, eszopiclone did not worsen AHI, and it improved sleep maintenance and efficiency. Further study is warranted to determine whether eszopiclone could improve CPAP compliance or next-day function in patients with OSAS.
Annals of Internal Medicine, 2009
for the CPAP ASAP (CPAP Promotion and Prognosis-The Army Sleep Apnea Program) Trial 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 apneahypopnea index, 36.9 events/h [SD, 23]) with newly diagnosed obstructive sleep apnea initiating CPAP. Intervention: Eszopiclone, 3 mg (n ϭ 76), or matching placebo (n ϭ 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 ϭ 0.003), 1.3 more hours per night for all nights (CI, 0.4 to 2.2 hours; P ϭ 0.005), and 1.1 more hours per night of CPAP use (CI, 0.2 to 2.1 hours; P ϭ 0.019). The hazard ratio for discontinuation of CPAP was 1.90 (CI, 1.1 to 3.4; P ϭ 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.
Clinical Science, 2011
Recent insights into sleep apnoea pathogenesis reveal that a low respiratory arousal threshold (awaken easily) is important for many patients. As most patients experience stable breathing periods mediated by upper-airway dilator muscle activation via accumulation of respiratory stimuli, premature awakening may prevent respiratory stimuli build up as well as the resulting stabilization of sleep and breathing. The aim of the present physiological study was to determine the effects of a non-benzodiazepine sedative, eszopiclone, on the arousal threshold and the AHI (apnoea/hypopnoea index) in obstructive sleep apnoea patients. We hypothesized that eszopiclone would increase the arousal threshold and lower the AHI in patients with a low arousal threshold (0 to −15 cmH2O). Following a baseline overnight polysomnogram with an epiglottic pressure catheter to quantify the arousal threshold, 17 obstructive sleep apnoea patients, without major hypoxaemia [nadir SaO2 (arterial blood oxygen satu...
Sleep, 2006
Assess the effect of the hypnotic zolpidem on the efficacy of nasal continuous positive airway pressure for treatment of Obstructive Sleep Apnea Design: Randomized double blind placebo controlled, cross-over study Setting: Veterans Administration Medical Center Patients: 16 patients with severe obstructive sleep apnea (apnea+ hypopnea index >30/hr), on CPAP therapy for at least 6 months Intervention: Three sleep studies were performed over three consecutive weeks. On night one the pressure level required to prevent apnea, hypopnea, and snoring was determined. On the second and third study nights, either placebo (P) or 10 mg of zolpidem (Z) was given (random order) and subjects slept on the CPAP level determined on the first night. Measurements: Sleep architecture, apnea + hypopnea index, arterial oxygen saturation Results: The sleep architecture was similar on the placebo and zolpidem nights except for a decrease in the sleep latency (P: 23.5 ± 4.7 ; Z: 13.1 ± 3.3 minutes, P < 0.02) and a small decrease in the arousal index (P < 0.03) on zolpidem nights. The was no significant difference between placebo and zolpidem nights in the apnea + hypopnea index (P: 4.8 ± 1.4 versus Z : 2.7 ± 0.47 events/hour), oxygen desaturation index (1.46 ± 0.53 versus 0.81 ± 0.29 desaturations/hour), or the lowest SaO 2 (91.4 ± 0.6 versus 91.0 ± 0.7 %) Conclusions: Acute administration of zolpidem 10 mg does not impair the efficacy of an effective level of CPAP in patients with severe obstructive sleep apnea.
Sleep Medicine–Time for a Change
Journal of Clinical Sleep Medicine, 2006
Sleep Medicine-Unprecedented Growth Since the 1980s Sleep medicine has seen an unprecedented growth in the last 2 decades. It is estimated that, throughout the United States in 1292 sleep clinics, at least 1.17 million people were examined during 2001. 1 These numbers have likely doubled since then, and other countries have seen a similar growth in the field of sleep medicine. 2 This dramatic increase in sleep clinics and the number of polysomnographic recordings is undoubtedly explained by the growing awareness of obstructive sleep apnea syndrome and its profound impact on patients' quality of life and health. At least 85% of patients are referred to a sleep examination in a laboratory because of suspected sleep apnea, which affects, in at least moderate form, 1 in 10 men and 1 in 25 women. 3 For people over 60 years of age and in certain high-risk populations, such as obese people or habitual snorers, there are more people with breathing disorders during sleep than without. 4 The fact that the field of sleep medicine is overwhelmingly centered on a single disorder, sleep apnea, explains why sleep medicine has become almost a subspecialty of pulmonary medicine in the last few years and why more than 50% of diagnostic sleep laboratory directors are pulmonologists. 1 This is a complete turnabout from the 1970s and 1980s when the vast majority of sleep specialists were neurologists, psychiatrists, and psychologists. This may be changed, however, as a result of the decision of the Accreditation Council for Graduate Medical Education to approve the sleep medicine fellowship training programs that may open sleep medicine to other medical specialties. Sleep Medicine-Practiced Now as 20 Years Ago The focus of sleep medicine on a single disorder and the dominance of pulmonologists in this field have not affected the practice of sleep medicine in any major way. Examinations to diagnose breathing disorders in sleep are carried out in more or less the same way as they were done 20 or 30 years ago by sleep specialists who mostly examined patients complaining of insomnia or suspected sufferers of narcolepsy. 5 There has been, however, impressive progress in data-acquisition and data-storage technologies. Electrophysiologic recordings have moved from analog to digital, and data are no longer stored on miles and miles of recording paper but on compact, miniature, digital, storage media. Also, more detailed and focused guidelines have been developed to quantify respiratory events during sleep that were not given much clinical importance just 20 years ago. Thus, a person suspected of having sleep apnea is referred to a sleep clinic and spends the night there connected to electrophysiologic recordings that monitor electroencephalography, electrooculography, electromyography, respiratory effort, airflow, body position, and arterial oxygen saturation level, all of which provide the necessary information for a diagnosis. Presenting symptoms and medical history are also taken into consideration in the diagnostic process and treatment recommendation. To save the patients' time and the insurance companies' money, many of the diagnostic sleep recordings performed nowadays are based on only half of the night (the so-called split-night procedure). 6 If the pa
Archivos De Bronconeumologia, 2007
OBJECTIVE: The aim of this study was to analyze the frequency of initiation of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea syndrome (OSAS) in a referral hospital in Mexico City serving mainly patients without public health insurance coverage and to assess their level of adherence. PATIENTS AND METHODS: Patients with OSAS diagnosed by polysomnography or by simplified respiratory polygraphy for whom nasal CPAP was prescribed were enrolled in the study. Titration of CPAP was performed during polysomnography or with an automatic CPAP device. Compliance with treatment was assessed during a medical visit or by telephone interview.
Disturbed sleep in obstructive sleep apnea expressed in a single index of sleep disturbance (SDI)
Somnologie - Schlafforschung und Schlafmedizin, 2008
Introduction: Insufficient sleep during polysomnography can produce poor quality studies or incomplete CPAP titrations. Non-benzodiazepines improve sleep without disrupting sleep architecture or exacerbating sleep-disordered breathing and should improve polysomnographic quality. Methods: Prospective, double-blinded, placebo-controlled trial assessing quality of polysomnography with eszopiclone premedication. We compared sleep latency, efficiency, sleep time and AHI between eszopiclone 3mg or matching placebo. We compared rates of inadequate studies between groups, defined as insufficient sleep time (<120 minutes or sleep efficiencies <70%) or incomplete CPAP titrations (>5 events/hour on the highest CPAP or complete intolerance).
Sleep, 2016
Obstructive sleep apnea (OSA) results from the interaction of several physiological traits; specifically a compromised upper airway anatomy and muscle function, and two key non-anatomical deficits: elevated loop gain and a low arousal threshold. Although continuous positive airway pressure (CPAP) is an efficacious treatment, it is often poorly tolerated. An alternative approach could involve administering therapies targeting the non-anatomic causes. However, therapies (oxygen or hypnotics) targeting these traits in isolation typically improve, but rarely resolve OSA. Therefore, our aim was to determine how the combination of oxygen and eszopiclone alters the phenotypic traits and OSA severity and to assess the baseline phenotypic characteristics of responders/non-responders to combination therapy. In a single-blinded randomized crossover study, 20 OSA patients received combination therapy (3 mg eszopiclone and 40% oxygen) versus placebo/sham air, with 1 w between conditions. Under e...