Novel Insomnia Indication Shows Long-Term Efficacy and Safety on Sleep Onset, Maintenance

In data to be presented at this year's SLEEP 2020 virtual conference, Eisai Inc's lemborexant [DAYVIGO] showed statistically significant long-term efficacy and safety compared with placebo on sleep maintenance, onset of patients with insomnia disorder, said Margaret Moline, PhD, executive director and international project team lead for Eisai Inc.

Transcript

AJMC®: Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences’ Medical World News, The American Journal of Managed Care® is pleased to welcome Dr Margaret Moline, executive director and international project team lead for Eisai Inc. Can you just introduce yourself and tell us a little bit about your work?

Moline: I’m Margaret Moline as introduced, and as the international project team lead for lemborexant [DAYVIGO], I'm responsible for the global clinical development program, both for the insomnia indication that we'll be talking about today and for future work with lemborexant.

AJMC®: At this year’s SLEEP 2020 virtual conference, phase 3 data from the SUNRISE 2 trial on Dayvigo [lemborexant] will be presented. Can you discuss how the trial was conducted and what primary and secondary measures were analyzed?

Moline: Sure. So, the study that we're talking about is called SUNRISE 2, or Study 303. It was a 1-year study of adult patients with insomnia, who had difficulty falling asleep or staying asleep or both. So, assuming that they met provisional criteria, they were randomized to treatment with lemborexant, 1 of 2 different doses of lemborexant, or placebo. It was a 12-month study.

The first 6 months we had the placebo group to compare the effect of lemborexant to placebo. Then in the second half of this study, all those subjects were on active treatment. So, the study provided 2 types of data. One, the longer term data, because we were able to show lemborexant worked for across the 6 months of placebo control treatment, and then we also were studying people who started and stayed on lemborexant for a whole year. So, this provided us with long-term safety data, as well as showing persistence of effect in the second 6 months.

AJMC®: Based on SUNRISE 2 findings, can you discuss how Dayvigo fared on long-term efficacy and safety for adults 65 and older with insomnia disorder?

Moline: Sure. So, what we showed in the total patient population was that there was benefit on sleep onset and sleep maintenance compared with placebo. So, this meant that the subjects fell asleep faster so the change in their baseline was bigger and statistically significant compared to placebo, and this is also what we saw in the older patient population. As far as the side effects that we're seeing, they were very similar to the ones that we saw in the overall adult patient population. With lemborexant, the most common adverse reaction is somnolence–sleepiness. That was reported whether it was the adult patient population or the older patient population.

AJMC®: There are a total of 9 presentations at this year’s SLEEP 2020 virtual conference on Dayvigo. Can you speak on what these other presentations will discuss and any significant findings?

Moline: Two posters that are looking at transitioning a patient from their current zolpidem treatment to lemborexant. So, we wanted to understand who might be interested, what characteristics of the patients would be, who wanted to switch their zolpidem treatment to lemborexant. So, that's 1 poster, and the other poster related to that was understanding whether people could successfully transition from zolpidem to lemborexant, and we found that they could.

So, we hope that those are helpful to prescribing clinicians who may have patients that are looking to switch for a variety of different reasons and to provide some preliminary guidance in case that's a good therapeutic option for his or her patient.

Another poster that I think is important is 1 where we analyze data from the patient global impression of insomnia. So, this is asking a patient to rate how well the treatment worked from their perspective. On the questions like, did it help you fall asleep? Did you get more sleep? The patient answers that they had a positive effect or a neutral effect or a negative effect.

Then we can look at how much change in their sleep onset time or their total sleep time corresponds to a rating of positive or neutral or negative. This allows us to share the patient's view on what treatment means to them. I think this is an important set of data that can help a clinician understand the size of change that matters to a patient. So, when determining whether a therapy works for the patient or not, they have kind of a benchmark. So, that's another 1 of the posters that we're very happy to be presenting.