Sleep medicine · 2025
Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Khullar Atul, Boulos Mark I, Mak Michael S B, Moline Margaret, Cheng Jocelyn Y, Hall Nancy
Аннотация
OBJECTIVE: To evaluate sleep parameters and architecture in a post hoc analysis of participants with untreated obstructive sleep apnea (OSA) who received lemborexant (LEM) 10 mg (LEM10), a competitive dual orexin-receptor antagonist approved for the treatment of adults with insomnia.
METHODS: Study E2006-A001-102 (Study 102; NCT03471871) and Study E2006-A001-113 (Study 113; NCT04647383) were multicenter, randomized, double-blind, placebo (PBO)-controlled, 2-period cross-over studies in participants with mild OSA (apnea-hypopnea index [AHI] ≥5 to <15 events/hour) and moderate (AHI ≥15 to <30 events/hour) or severe OSA (AHI ≥30 events/hour), respectively. Participants were randomized to 1 of 2 treatment sequences (Sequence A: PBO/LEM10; Sequence B: LEM10/PBO) consisting of 8 nights of treatment (LEM10 or PBO), with each treatment period separated by a ≥14-day washout period. Sleep onset, maintenance, and architecture data were assessed on Day 1 and Day 8 with polysomnography. Safety data were collected.
RESULTS: In total, 39 patients with mild OSA and 33 patients with moderate or severe OSA were included. Total sleep time and sleep efficiency were significantly higher (improved) following single and multiple doses of LEM10 regardless of OSA severity. Following single and multiple doses of LEM10, wake after sleep onset was significantly lower (improved) and total non-rapid eye movement (REM) sleep and REM sleep duration were longer versus PBO. LEM10 was generally well tolerated.
CONCLUSIONS: These results, in combination with previously reported respiratory safety data, suggest that LEM may be an insomnia treatment option for patients with untreated OSA.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03471871); ClinicalTrials.gov (identifier: NCT04647383).
METHODS: Study E2006-A001-102 (Study 102; NCT03471871) and Study E2006-A001-113 (Study 113; NCT04647383) were multicenter, randomized, double-blind, placebo (PBO)-controlled, 2-period cross-over studies in participants with mild OSA (apnea-hypopnea index [AHI] ≥5 to <15 events/hour) and moderate (AHI ≥15 to <30 events/hour) or severe OSA (AHI ≥30 events/hour), respectively. Participants were randomized to 1 of 2 treatment sequences (Sequence A: PBO/LEM10; Sequence B: LEM10/PBO) consisting of 8 nights of treatment (LEM10 or PBO), with each treatment period separated by a ≥14-day washout period. Sleep onset, maintenance, and architecture data were assessed on Day 1 and Day 8 with polysomnography. Safety data were collected.
RESULTS: In total, 39 patients with mild OSA and 33 patients with moderate or severe OSA were included. Total sleep time and sleep efficiency were significantly higher (improved) following single and multiple doses of LEM10 regardless of OSA severity. Following single and multiple doses of LEM10, wake after sleep onset was significantly lower (improved) and total non-rapid eye movement (REM) sleep and REM sleep duration were longer versus PBO. LEM10 was generally well tolerated.
CONCLUSIONS: These results, in combination with previously reported respiratory safety data, suggest that LEM may be an insomnia treatment option for patients with untreated OSA.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03471871); ClinicalTrials.gov (identifier: NCT04647383).