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Plain Language Summary
What is this summary about?
This is a summary of an article originally published in the journal Postgraduate Medicine. Lemborexant is a type of medication called a dual orexin receptor antagonist (often abbreviated to DORA) that is approved for treating people with insomnia, a sleep disorder in which people have trouble falling asleep, staying asleep or both. Two studies, one called SUNRISE-1 (Study 304), which lasted one month, and SUNRISE-2 (Study 303), which lasted 12 months, looked at the effects of lemborexant on sleep compared to placebo in people with insomnia. People with insomnia often experience fatigue (or tiredness) during the daytime, which affects their daily lives and health, and often have other conditions which can also cause fatigue. This summary reports an analysis that looked at whether lemborexant improves fatigue during the daytime as well as nighttime symptoms of insomnia in all participants and in participants with clinically significant fatigue before treatment.
What were the results?
In both studies, participants completed a questionnaire, called the Fatigue Severity Scale, that measured how significant their fatigue was. The researchers looked at the change in fatigue over time in participants treated with lemborexant compared with those given placebo. They also looked at the change in a group of participants who reported clinically important levels of fatigue at the beginning of the study. People in these studies also completed diaries about how long it took them to fall asleep and how long they slept. The researchers compared improvements in fatigue with changes in how participants slept over time. Overall, lemborexant reduced daytime fatigue compared with placebo in all study participants. It also reduced daytime fatigue in the smaller group of participants who had clinically significant fatigue at the beginning of the study. The reductions in fatigue seen with lemborexant remained during 1 year of treatment. There was also a relationship between reduced fatigue, falling asleep faster and not waking up as much.
What do the results mean?
Researchers concluded that in addition to improving sleep in people with insomnia, lemborexant can reduce daytime fatigue.
This is an abstract of the Plain Language Summary of Publication article.
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Link to original article here
Financial & competing interests disclosure
Craig Chepke has received research support from Axsome Therapeutics and Harmony Biosciences; has served as a consultant to Corium; has served on the advisory board of Karuna; has received speakers fees from Merck and Sunovion; has received speaker fees and served on the advisory board for Intracellular, Ironshore, and Takeda; has received speaker fees, served as a consultant and served on the advisory board for AbbVie, Alkermes, Eisai Ltd, Jazz, Lundbeck, Janssen, Noven and Otsuka; has received speaker fees, served as a consultant, served on the advisory board for and has received research support from Acadia, Neurocrine and Teva Pharmaceuticals. Rakesh Jain has served as a consultant for Acadia, Alfasigma, Eisai Ltd, Evidera, Impel NeuroPharma and Osmotica Pharmaceuticals; has received speaker fees from Ironshore Pharmaceuticals and Tris Pharmaceuticals; has received speaker fees and served on the advisory board for Alkermes; has served as a consultant for, received research support and received speaker fees from Allergan; has served as a consultant and on the advisory board for Neurocrine Biosciences, Supernus and Teva Pharmaceuticals; has received speaker fees and has served as a consultant and on the advisory board for Janssen, Merck, Neos Therapeutics, Pamlab and Sunovion Pharmaceuticals; and has received research support, speaker fees and has served as a consultant and on the advisory board for Eli Lilly and Company, Lundbeck, Otsuka, Pfizer, Shire and Takeda. Russel Rosenberg has received grants from and is on the advisory board for Eisai Ltd. Margaret Moline, Dinesh Kumar and Carlos Perdomo are employees of Eisai Ltd. Jane Yardley and Kate Pinner are employees of Eisai Ltd. Gleb Filippov, Norman Atkins and Manof Malhotra were employees of Eisai Ltd during the data analysis for this manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Writing support for this summary was provided by Jenna Steere, PhD, of Envision Pharma Group and was funded by Eisai Ltd, 200 Metro Blvd, Nutley, NJ 07110 USA; telephone: +1 201 692 1100. Authors of the full article were involved in preparing this summary.
Ethical conduct of research
SUNRISE-1 and -2 were approved by independent ethics committees and conducted in accordance with relevant clinical guidelines. All patients provided written informed consent.