Phase 3 Results for Investigational Insomnia Agent Suggest Efficacy
Abstract
People with insomnia who take the investigational agent lemborexant may find themselves falling asleep faster and sleeping more soundly, according to data presented in February by Eisai Co. Ltd. and Purdue Pharma L.P.
As part of the phase 3 trial, 949 adults with insomnia disorder were randomized to lemborexant (5 mg or 10 mg) or placebo for six months. Participants were asked to keep electronic sleep diaries throughout the trial.
At the end of six months, patients who took lemborexant 5 mg reported falling asleep roughly 22 minutes faster on average than before, and those who took lemborexant 10 mg reported falling asleep roughly 28 minutes faster on average than before. Those who took placebo reported falling asleep roughly 12 minutes faster on average. Patients assigned to lemborexant also reported that they had slept better and had longer periods of sleep compared with those in the placebo group.
Lemborexant is thought to work by blunting wakefulness without impeding the ability to awaken in response to external stimuli. ■