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.

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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.

Reference

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.