Efficacy of Lemborexant in Adults ≥ 65 Years of Age with Insomnia Disorder

• DOI: 10.1007/s40120-024-00622-9
• Publication Date: 2024-05-15T13:02:07Z
• Authors: Valerie Arnold; Sonia Ancoli-Israel; Thien Thanh Dang-Vu; Kazuo Mishima; Kate Pinner; Manoj Malhotra; Margaret Moline
• Keywords: Alertness; Sleep onset latency; Primary Insomnia; Epworth Sleepiness Scale

Pharmacologic treatments are available to treat insomnia, a common and burdensome sleep disorder, but may be contraindicated in older adults who prone side effects from sleep-promoting drugs. These analyses of diary data Study E2006-G000-303 (Study 303) investigated the benefits lemborexant 5 mg (LEM5) 10 (LEM10) subgroup age ≥ 65 years with insomnia. 303, 12-month, double-blind study LEM5 LEM10 (age 18 years) insomnia disorder (sleep onset and/or maintenance difficulties) assessed subject-reported (subjective) sleep-onset latency (sSOL), efficiency (sSE), wake after (sWASO), total time (sTST). Morning sleepiness/alertness, severity (Insomnia Severity Index [ISI]), fatigue (Fatigue Scale [FSS]), perceptions sleep-related medication (Patient Global Impression–Insomnia [PGI-I] questionnaire), safety were also evaluated. In this (≥ years; n = 262), there significantly larger changes baseline for sSOL, sSE, sTST, sWASO versus placebo through month 6 (except 1), indicating improvement; these improvements sustained 12. Subject-reported increases morning alertness greater one or both LEM doses There ISI daytime functioning score decreases (improvement) at months 1, 3, (total score: doses; functioning: 1 3 6) FSS (both doses), Compared placebo, more subjects reported that doses) positively impacted ability sleep, fall asleep, TST 6, 12, no rebound drug withdrawal. was well tolerated 12; mild somnolence most treatment-emergent adverse event. Improvements efficacy LEM-treated observed as early first week treatment end tolerated. ClinicalTrials.gov identifier NCT02952820: E2006-G000-303; 303; SUNRISE-2 (First posted: October 2016); EudraCT 2015-001463-39 November 2016). Insomnia is associated significant difficulties, particularly adults. Although many available, some important risk not adequately (ability stay asleep), which frequent complaint people. Lemborexant has been approved multiple countries based on studies show improved adults' asleep To examine long-term benefit lemborexant, we participated 1-year study. The results showed within few days taking lasting 12 treatment, nightly nighttime (that is, it reduced took awake during night, increased time) than placebo. compared addition, those their symptoms less severe they had suggest good option disorder.