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Lemborexant Improves Sleep, Reduces Daytime Fatigue in Patients With Insomnia
A dual orexin receptor antagonist, lemborexant, improves sleep onset and sleep maintenance in patients with insomnia and reduces daytime fatigue, according to a study recently published in Postgraduate Medicine.
The study was co-authored by Psych Congress Network’s Bipolar Disorder Section Editor, Craig Chepke, MD, FAPA, Psych Congress Steering Committee Member, Rakesh Jain, MD, MPH, and colleagues.
“To our knowledge, this is the first report on the effect of orexin receptor antagonists on fatigue severity scores in adults with insomnia disorder,” researchers said in the study.
To evaluate the effectiveness of a dual orexin receptor antagonist in reducing fatigue associated with insomnia, Chepke, Jain, and co-authors analyzed 2 phase 3, global, multicenter, randomized, double-blind, parallel-group studies of subjects with insomnia disorder—study E2006-G000-303 (SUNRISE-2) and study E2006-G000-304 (SUNRISE-1).
Subjects received placebo (n = 318), lemborexant 5 mg (n = 316), or lemborexant 10 mg (n = 315) in the 12-month SUNRISE-2 study that was placebo controlled for the first 6 months.
SUNRISE-1 was a 1-month, placebo- and active-controlled study in older adults, categorized as females ≥55 years and males ≥65 years. After a placebo run-in period of approximately 2 weeks, subjects were randomized in a double-blind, double-dummy manner to placebo (n = 208), lemborexant 5 mg (n = 266), and lemborexant 10 mg (n = 266) for a 1-month treatment period.
The Fatigue Severity Scale (FSS) was used to assess the impact of fatigue on daily functioning and quality of life on study subjects. Using data from electronic sleep diaries, researchers analyzed patient-reported sleep onset and sleep maintenance endpoints.
Over a 6-month treatment period in the overall population and in subjects with “clinically meaningful fatigue” (FSS total score ≥36) at baseline, lemborexant significantly reduced subject-reported fatigue versus placebo. The FSS total score least-squares mean (LSM) treatment difference was -2.50 and -2.56 for 5 and 10 mg of lemborexant, respectively. These results were sustained over 12 months.
“The general treatment of fatigue in disorders other than insomnia is to use wake-promoting agents such as psychostimulants, or off-label bupropion, methylphenidate, modafinil, or amantadine. Such drugs may have the potential for adverse reactions or carry the risk of abuse and dependence,” researchers concluded in the study. “The use of lemborexant to treat insomnia-related fatigue may therefore offer a valuable alternative….While improvements in sleep quality are evident after 1 week of treatment, longer-term lemborexant treatment for periods of more than 1 month may be needed for improvement in insomnia-related fatigue.”
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