AAN 2025 | The impact of lemborexant on daytime functioning in adults with insomnia

So because when considering a hypnotic for a patient to treat insomnia, it’s important to balance again efficacy and safety. So we looked and especially asked how the person’s life is being impacted. So it’s one thing to be able to say you’ve got 20 more minutes as measured on an objective sleep study, a polysomnogram, but the patient needs to be able to tell that his or her sleep has improved. So we had a variety of different methods that we used in the Lemborexant Clinical Development Program to take a look at daytime function. So the paper that we’re talking about contains analyses from another one of our pivotal studies. This is a long-term efficacy and safety study. The long-term efficacy component was six months of double-blind placebo controlled treatment. Lemborexant in five milligrams, 10 milligrams, and placebo in adults 18 and up with insomnia disorder. And the second half of the study looked at the continuation of treatment for another six months, but we’re talking about the first six months here. So we used the insomnia severity index, the ISI, which is a widely used research instrument that looks at, by its name, you can tell insomnia severity. And it also has some components, not just the symptoms of falling asleep and staying asleep, but also daytime function. So you can split the scale into two component parts and look at change from baseline in both of those components. We also included the fatigue severity scale. And even though the subjects were not required to have significant fatigue at baseline, we still wanted to see whether fatigue would improve because fatigue is a very common symptom of patients with insomnia. So mostly we were looking for concordance between what we knew about changes in the sleep parameters from the patient perspective, and that’s ascertained using sleep diaries. But we also wanted to see what happened on those scales. So what we were able to show was that there was a change from baseline in the insomnia severity over time and also in the symptoms from the questions from the ISI that are for daytime functioning and with the fatigue severity scale. What was really interesting was that the insomnia scale showed changes from baseline that were larger and statistically significantly different from placebo as assessed at the first month, but not fatigue in our one-month study. It took longer for the fatigue symptoms to show a significant difference from placebo. So it might be that patients need many more weeks of good sleep to be able to see a change in that important parameter. So those are basically the take-homes from that paper, too. It just emphasizes the importance of having a varied approach to the assessment of the impact of insomnia on the person. That it’s not just how fast they fell asleep or how much more sleep they had, but how it translates into their daytime functioning. After all, one of the criteria for insomnia disorders is that the symptoms have an impact on the person’s life.

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