Lemborexant Continues to Show Efficacious Profile in Obstructive Sleep Apnea Without Insomnia

Gary K. Zammit, PhD

In an analysis of 2, double-blind, placebo-controlled crossover studies, Lemborexant (Dayvigo; Eisai), an FDA-approved medication for insomnia, was effective in the treatment of patients with obstructive sleep apnea (OSA) without insomnia. Presented at the 2023 SLEEP Annual Meeting, held June 3-7, in Indianapolis, Indiana, Lemborexant continued to increase total sleep, non-REM sleep, and REM sleep in comparison with placebo.

Led by Gary K. Zammit, PhD, president and chief executive officer, Clinilabs Drug Development, the analysis featured 39 individuals with mild OSA and 33 with moderate to severe OSA. Patients randomly were assigned to Lemborexant 10 mg or placebo for 2, 8-night treatment periods, separated by at least 14 days. Investigators compared least-square means (LSM) for each sleep stage (minutes) across conditions on Days 1 (D1) and 8 (D8) of treatment.

At the conclusion of the analysis, findings showed that lemborexant-treated individuals with mild OSA had significantly higher total sleep time on both D1 (434.08 vs 385.46; P <.0001) and D8 (415.90 vs 386.85; P = .003). Investigators continued to see statistically significant differences in the moderate to severe groups as well (D1: 423.10 vs 385.48; P <.0001; D8: 416.96 vs 385.57; P = .001). Above all, lemborexant continued to be well-tolerated, with treatment-emergent adverse events that were mild in nature.

Compared with placebo, results showed that total non-REM sleep significantly increased only in D1 in individuals with mild OSA (D1: lemboraxant: 330.57; placebo: 308.55; P = .001; D8: lemborexant: 323.77; placebo: 308.97; P = .060) but on both days in participants with moderate to severe OSA (D1: lemborexant: 343.23; placebo: 327.45; P = .0006; D8: lemborexant: 341.83; placebo: 322.48; P = .018). Total REM sleep significantly increased in subjects with mild (D1: lemborexant: 103.59; placebo: 76.91; P < 0.0001; D8: lemborexant: 92.13; placebo: 77.93; P=0.004) and moderate/severe (D1: lemborexant: 79.87; placebo: 58.03; P < 0.0001; D8: lemborexant: 75.13; placebo: 62.69; P = 0.006) OSA.

Patients on the study drug also saw benefits in REM latency, as investigators observed significant decreases in both the mild OSA (D1: lemborexant: 51.96; placebo: 83.36; P <.0001; D8: lemborexant: 67.52; placebo: 102.34; P = .0005) and moderate to severe OSA (D1: lemborexant: 72.13; placebo: 98.90; P = 0.029; D8: lemborexant: 90.42; placebo: 106.63; P = .242).

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Lemborexant, a dual-orexin-receptor antagonist approved to treat insomnia, has demonstrated efficacy and safety in this patient population several times since its initial approval. At the 2021 SLEEP Annual Meeting, 12-month data from Study 303 (NCT02952820) continued to show positive medication effect in patients with insomnia. The study featured 949 individuals randomly assigned to either 5-mg Lemborexant (n = 316), 10-mg Lemborexant (n = 315), or placebo (n = 318).

At month 9, more than 70% of those in both treatment arms (5 mg: 73.4% [177 of 241]; 10 mg: 76.3% [161 of 211]) reported that the therapy helped them sleep, with similar results at month 12 (5 mg: 74.6% [153 of 205]; 10 mg: 77.6% [149 of 192]). Additionally, the majority of patients reported that lemborexant increased total sleep time at both month 9 (5 mg: 62.2% [150 of 241]; 10 mg: 73.0% [154 of 211]) and month 12 (5 mg: 62.4% [128 of 205]; 10 mg: 65.1% [125 of 192]).

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REFERENCES
1. Zammit G, Cheng J, Hall N, Shah D, Moline M. Effect of Lemborexant on sleep architecture in adult and elderly subjects with mild to severe obstructive sleep apnea. Presented at: 2023 SLEEP Annual Meeting; June 3-7; Indianapolis, Indiana. Abstract 0353
2. Drake C, Yardley J, Pinner K, Perdomo C, Moline M. Long-term Perception of Medication Effectiveness in Subjects Receiving Lemborexant for Up to 12 Months. Presented at: SLEEP 2021; Virtual; June 10-13, 2021. Poster 339.