Lemborexant Improves Fatigue, Sleep Parameters Among Older Adults

Adults aged 65 years or older who had clinically significant fatigue at baseline had greater improvements in the Fatigue Severity Scale (FSS) total score and all sleep parameters 6 months later, compared with placebo, a post hoc analysis of a phase 3 trial showed.

The findings were presented in a poster at the virtual 2021 annual meeting of the American Association for Geriatric Psychiatry.

The analysis looked at a subgroup of 134 people aged 65 years or older from the 949 adult participants in a 12-month, randomized, double-blind study. Participants received either 10 mg of lemborexant, 5 mg of lemborexant, or placebo. Lemborexant is a dual orexin receptor antagonist approved for the treatment of adults with insomnia.

Mean reductions from baseline in FSS total score were significantly greater in the lemborexant groups, compared with the placebo group, at the end of Month 6. The 5 mg group had a slightly higher score than the 10 mg group.

At the end of Month 6, 68.3% of participants taking lemborexant 10 mg and 58.5% of those taking lemborexant 5 mg had an FSS total score of less than 36, the threshold for clinically significant fatigue, compared with 34.1% of the participants receiving placebo.

The reductions in fatigue generally paralleled the time course of improvements in sleep parameters such as subject-estimated time to fall asleep, sleep efficiency, and the subject-estimated amount of wakefulness time after initial sleep onset.

The study was funded by Eisai Inc., the maker of lemborexant (Dayvigo).

—Terri Airov

Reference
Jain R, Chepke C, Pinner K, et al. Impact of lemborexant on fatigue severity and sleep outcomes in older adults with clinically significant fatigue at baseline. Posted presented at the American Association for Geriatric Psychiatry 2021 Annual Meeting; March 15-19, 2021; Virtual.