Work

Respiratory safety of lemborexant in adult and elderly subjects with moderate‐to‐severe chronic obstructive pulmonary disease

Year: 2024

Type: article

Abstract: Summary Because some hypnotics worsen respiratory conditions, it was important to determine the respiratory safety of lemborexant, a competitive dual orexin‐receptor antagonist approved to treat adults with insomnia, in subjects with moderate‐to‐severe chronic obstructive pulmonary disease. E2006‐A001‐113 (Study 113; NCT04647383) was a multicentre, multiple‐dose, randomised, double‐blind, placebo‐controlled, two‐period crossover study in adult subjects with moderate or severe chronic obstructive pulmonary disease (per spirometry‐based Global Initiative for Chronic Obstructive Lung Disease [GOLD] criteria). Subjects (N = 30) were randomised to two treatment sequences comprising 8‐night treatment periods (washout ≥ 14 days) with lemborexant 10 mg or placebo. Peripheral oxygen saturation (SpO2; primary endpoint), apnea–hypopnea index, objective sleep parameters and sleep architecture measures were assessed after single (Day 1) and multiple (Day 8) doses. There was no significant difference in least‐squares mean SpO2 after a single dose of lemborexant (91.1%) versus placebo (91.5%). Although a statistically significant difference in SpO2 was observed after multiple doses (least‐squares mean: lemborexant, 91.3%; placebo, 90.8%) favouring lemborexant, this was not considered clinically meaningful. Apnea–hypopnea index was not significantly different between treatments after single or multiple doses. Total sleep time and total rapid eye movement sleep were significantly greater on Days 1 and 8 with lemborexant versus placebo. Treatment‐emergent adverse events were reported in five (16.7%) subjects when taking lemborexant and four (13.3%) subjects when taking placebo; treatment‐emergent adverse events were mostly mild. Lemborexant was well tolerated and did not adversely impact SpO2 or apnea–hypopnea index after single and multiple doses relative to placebo in subjects with moderate‐to‐severe chronic obstructive pulmonary disease.

Source: Journal of Sleep Research

DOI: 10.1111/jsr.14334

Authors: Jocelyn Y. Cheng, Daniel Lorch, Nancy Hall, Margaret Moline

Institution: Eisai (United States)

Language: English

Topic: Chronic Obstructive Pulmonary Disease (COPD) Research

Subfield: Pulmonary and Respiratory Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,130