Abstract Details

Title Effect of Lemborexant on Fatigue Severity and Sleep Outcomes Over 12 Months in Subjects With Clinically Significant Fatigue at Baseline

Topic Sleep

Presentation(s) Sleep Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 008

Background The Fatigue Severity Scale (FSS) is a self-report questionnaire that assesses the impact of fatigue on patients’ lives (total score [TS] ≥36 indicates CSF). In Study 303 (SUNRISE-2), significant benefit on subjective fatigue was observed with LEM versus placebo (PBO) over 6mo.

Objective To assess effect of lemborexant (LEM) on fatigue severity and sleep outcomes in subjects with insomnia disorder and clinically significant fatigue (CSF) at baseline.

Design/Methods Study 303 was a 12mo, randomized, double-blind study in adults (≥18y; n=949). Subjects received PBO or LEM (5mg [LEM5]; 10mg [LEM10]) the first 6mo (Period-1). The second 6mo (Period-2), PBO subjects were rerandomized to LEM (reported separately); LEM subjects remained on assigned treatment. Changes from baseline for LEM vs PBO in FSS-TS, subjective sleep onset latency (sSOL), sleep efficiency (sSE), and wake after sleep onset (sWASO) were analyzed post hoc in subjects with CSF at baseline.

Results In the CSF subgroup, mean baseline FSS-TS was 45.7, 46.4, and 45.8 for PBO (n=170), LEM5 (n=181), and LEM10 (n=173), respectively. Mean(SD) decreases from baseline in FSS-TS were significantly greater with LEM versus PBO at 6mo (PBO, −11.0[11.7]; LEM5, −15.4[13.8]; LEM10, −15.0[14.2]; both P<0.05), and sustained at 12mo (LEM5, −20.4[12.8]; LEM10, −17.7[15.0]). Median decreases from baseline in sSOL (min) were greater with LEM versus PBO at 6mo (PBO, −14.3; LEM5, −20.7; LEM10, −25.7); reductions persisted at 12mo (LEM5, −24.3; LEM10, −27.9). Mean(SD) increases from baseline in sSE (%) were greater with LEM versus PBO at 6mo (PBO, 11.1[13.3]; LEM5, 16.1[15.6]; LEM10, 14.7[16.2]) and 12mo (LEM5, 16.2[14.3]; LEM10, 16.9[15.9]). Mean(SD) decreases from baseline in sWASO (min) were greater for LEM versus PBO at 6mo (PBO, −31.9[57.6]; LEM5, −59.2[73.2]; LEM10, −48.1[70.2]) and 12mo (LEM5, −57.5[62.9]; LEM10, −60.4[72.0]).

Conclusions

In CSF subjects, LEM benefits on both FSS-TS and sleep measures were observed at both 6mo and 12mo.

Authors/Disclosures
Craig Chepke (Excel Psychiatric Associates) PRESENTER	Craig Chepke has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Craig Chepke has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Otsuka. Craig Chepke has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Craig Chepke has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Neurocrine. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AbbVie. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Acadia. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Otsuka. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Takeda. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Janssen. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Ironshore. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Craig Chepke has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. Craig Chepke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Intracellular. Craig Chepke has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eisai. Craig Chepke has received research support from Acadia. Craig Chepke has received research support from Harmony. Craig Chepke has received research support from Neurocrine.
	No disclosure on file
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Margaret Moline	Margaret Moline has received personal compensation for serving as an employee of EISAI, INC.. Margaret Moline has received intellectual property interests from a discovery or technology relating to health care. Margaret Moline has received personal compensation in the range of $0-$499 for serving as a review, loan repayment program with NIH.
	No disclosure on file
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.