Once-daily treatment with lemborexant at 5 mg and 10 mg per dose is associated with a noticeable reduction in subject-reported fatigue over a 6 month period in patients with insomnia disorder. This according to study results presented at World Sleep 2019, held September 20 to 25, in Vancouver, Canada.
In the phase 3 trial, patients with insomnia disorder (median age, 55 years [range, 18-88 years]) were randomly assigned to received either placebo (n=318), lemborexant 5 mg (LEM5; n=316) or lemborexant 10 mg (LEM10; n=315) for 6 months. Researchers assessed changes in the Fatigue Severity Score from baseline to follow-up. Data were analyzed at 1, 3 and 6 month intervals.
At baseline, the mean Fatigue Severity Score total scores were 35.2 for patients who received placebo, 37.4 for those who received LEM5, and 36 for those who received LEM10. A greater mean change in the mean Fatigue Severity Score total scores were observed for LEM5 and LEM10 vs placebo (-7.7 and -7.9 vs -4.3, respectively).
Compared with placebo, the reduction in mean Fatigue Severity Score total scores were larger for LEM5 (least squares mean treatment difference, -2.18; P =.0206) and LEM10 (least squares mean treatment difference, -3.04; P =.0014). At 6-month follow-up, reductions in the mean Fatigue Severity Score total scores were consistently greater for LEM5 (least squares mean treatment difference, -2.50; P =.0134) and LEM10 (least squares mean treatment difference, -2.56; P =.0128) vs placebo.
In a subset of patients with a modest degree of fatigue (eg, Fatigue Severity Score total scores of ≥18), a ≥30% reduction in total scores by month 6 was observed in 33.9% of patients who received placebo, 45.0% of those who received LEM5, and 51.7% of patients who received LEM10. The majority of adverse events associated with lemborexant in this study were considered mild to moderate in severity.
“These results demonstrate that treatment with [lemborexant] was associated with a clinically significant reduction in fatigue in subjects with insomnia disorder,” concluded the researchers.
Disclosure: This study was funded and sponsored by Eisai Inc and Purdue.
Yardley J, Moline M, Pinner K, et al. Long-term effect of lemborexant on fatigue in subjects with insomnia disorder: patient-reported outcome from the 6-month placebo-controlled treatment period of the phase 3 study sunrise-2. Poster presented at: World Sleep 2019; September 20-25, 2019; Vancouver, Canada.