Respiratory Safety of Lemborexant in Healthy Subjects: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Crossover Study.

Insomnia is a sleep disorder in which people have trouble falling asleep or staying asleep, or both. People can take prescription medicines to help improve sleep, but these drugs can have side effects including making breathing more difficult during sleep. We looked at a new medicine for insomnia, lemborexant, and with the aim of finding out how it affects breathing during sleep and if there were any side effects. A group of 17 healthy adult and elderly people took a normal or high dose of lemborexant or a placebo that did not contain active medicine. Researchers measured people's breathing while they slept. We found that lemborexant did not change the amount of oxygen in people's blood during sleep, and that lemborexant did not cause people to have shallow breathing or to have brief pauses in their breathing. People who took lemborexant reported few side effects and these were all mild. In this study, lemborexant was well tolerated in healthy adults and elderly people and did not make breathing more difficult during sleep.