Effects of suvorexant on sleep apnea in patients with heart failure: A protocol of crossover pilot trial

Abstract

Background: Suvorexant, an orexin receptor antagonist, is known as a safe and effective sleep medication. Many patients with heart failure (HF) have sleep-disordered breathing (SDB) and are short sleepers, and it is unknown whether suvorexant is effective in HF patients and can improve insomnia safely. The aim of this study is to examine the effect of suvorexant on SDB in patients with HF. Methods: The Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial) is a multicenter trial with a randomized double crossover design. We will enroll a total of 30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital. Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order. Before the study night, patients in the suvorexant first group will receive suvorexant for 4 consecutive days. There are at least 3 wash-out days between the study nights with and without suvorexant. Primary outcome measures of the noninferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB, and the results will be compared between the study nights with and without suvorexant. Conclusion:The present study can determine whether suvorexant can be used in HF patients without affecting their SDB. This is a pilot study to primarily assess whether suvorexant affects the severity of SDB in patients with HF. Therefore, further study is warranted to investigate whether suvorexant alters shortand long-term clinical outcomes by providing longer and better sleep in patients with HF.

Safety of Orexin Receptor Antagonist on Cardiac and Respiratory Function in Patients who Underwent Off-pump Coronary Artery Bypass Grafting

“…The respiratory effect of Suvorexant was reported in a few studies [6][7][8][9] . In healthy subjects with Suvorexant, the mean saturation of percutaneous oxygen (SpO 2 ) was >96% for all treatments during total sleep time and during both non-REM and REM sleep 8) .…”

“…In healthy subjects with Suvorexant, the mean saturation of percutaneous oxygen (SpO 2 ) was >96% for all treatments during total sleep time and during both non-REM and REM sleep 8) . Additionally, Shitara et al 6) presented that Suvorexant could be used in heart failure patients without affecting their sleep-disordered breathing. Sun et al 7,9) reported that no increase in mean apnea-hypopnea index was observed after a 40 mg dose of Suvorexant versus placebo and there was no treatment effect on mean SpO 2 during total sleep time in patients with obstructive sleep apnea.…”

“…Suvorexant improved sleep as assessed by the Insomnia Severity Index, and improved the impact of insomnia on daytime function/quality-of-life, too 1) . Additionally, the recent studies reported that Suvorexant had the effi cacy for the prevention of delirium during acute hospitalization [3][4][5] .There are a few reports about the respiratory effect of Suvorexant [6][7][8][9] . Though Shitara et al 6) reported that Suvorexant could be used in heart failure patients without affecting their sleep-disordered breathing, there were few studies to investigate the respiratory effect of Suvorexant after cardiac surgery.…”

“…There are a few reports about the respiratory effect of Suvorexant [6][7][8][9] . Though Shitara et al 6) reported that Suvorexant could be used in heart failure patients without affecting their sleep-disordered breathing, there were few studies to investigate the respiratory effect of Suvorexant after cardiac surgery. Additionally, there were few reports to demonstrate whether Suvorexant af-fected the cardiac functions.…”

Efficacy of dapagliflozin in the treatment of HFrEF with obstructive sleep apnea syndrome (DAHOS study): study protocol for a multicentric, prospective, randomized controlled clinical trial

“…Few studies have reported the pharmacological treatment of sleep apnea especially with heart failure [ 18 – 20 ]. We hypothesized that dapagliflozin, as a new star in the treatment of heart failure, could improve sleep apnea in heart failure patients.…”