AAN 2025 | A sub-analysis of the SUNRISE 1 trial of lemborexant in insomnia with mild obstructive sleep apnea

The data that we’re presenting at the AAN meeting is a sub-analysis from one of our pivotal studies, our study 304. That was a study of older individuals with insomnia, women 55 and up and men 65 and up, who met criteria for insomnia disorder. This was a one-month placebo-controlled randomized global study where we were primarily looking at the change in sleep parameters, like the time it takes to fall asleep, how long a person was awake during the night, and so on. The standard polysomnography endpoints, objective endpoints, used for registration and to understand how the drug works on insomnia. Because these were older subjects, we assessed their respiratory function to look for moderate to severe obstructive sleep apnea. Because we were studying people with insomnia disorder, we needed to rule out people who had moderate to severe OSA because they might need treatment for that disorder, and it would make it more complicated to understand the effects of lemborexant on the insomnia symptoms. However, that meant that there were a number of people who were eligible for the study who had mild obstructive sleep apnea. And those are the subjects that we looked at with respect to sleep parameters and the sleepiness and alertness during the day. So in addition to understanding what lemborexant, a dual orexin receptor antagonist, does for people with insomnia, we wanted to see whether there are any changes in the patient-reported outcome of sleepiness and alertness. When you are developing a drug for the treatment of patients with insomnia, it’s really important to have a balance of efficacy and safety. So from the efficacy perspective, of course you want to show that the drug helps people fall asleep faster, stay asleep for longer. But on the safety side, we have to make sure that the dose of drug is not so high that it would be causing morning residual effects, morning sleepiness. Because of course, that can impair the activities of daily living, especially getting to work and so on that that would be cause impairment. So one of the ways that we evaluated the propensity for impacting morning alertness, sleepiness alertness was by the use of a scale. So we asked patients every single morning to rate how they how they slept. So how long it took them to fall asleep, how much wakefulness they thought they had, and also how sleepy or alert they felt in the morning. This was using a nine-point scale from very, very sleepy to very, very alert. And so we could look at the change over time, comparing their baseline before treatment and after treatment with lemborexant. So what we were able to show, especially in the group with that reported mild to moderate sleepiness before the treatment started, was that the subjects tended to shift from less alertness to more alertness. So lemborexant has replicate evidence for improving sleep onset. So helping people fall asleep faster and staying asleep longer. So in addition to that, now we can say that it helped people with alertness, especially in helping them move from previous less, well, they were on the sleepy side of the scale, so under five, to more than five, which would be on the alert side of the scale. So that’s basically what we’re reporting in the patients who had sleep apnea, the mild sleep apnea. So not only was this true in the total population, but also in the subset of people that we’re reporting on this in this abstract who had both the mild obstructive sleep apnea and insomnia disorder. Some sleep-promoting drugs can impact respiratory function, and we know with lemborexant that that was not the case from other studies. But they can also cause morning sleepiness. So in people with mild obstructive sleep apnea, there can be already morning sleepiness. They can be sleepy during the day. So it was especially important for us to know whether the treatment was going to add to it. And as I mentioned, we helped people shift more toward the alert side. So that’s basically the story of the abstract.

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