Abstract Details

Title Effect of Lemborexant on Patient-Reported Distress About Sleeping and Interference with Daily Functioning in Subjects With Insomnia

Topic Sleep

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

Poster/Presentation
Number 010

Background The ISI questionnaire consists of 7 items and assesses patient perception of insomnia severity. In Study 303 (SUNRISE-2), greater decrease from baseline (improvement) in ISI total score was observed for LEM vs PBO at 6mo.

Objective Examine the effect of lemborexant (LEM) vs placebo (PBO) on items related to worry/distress about subjects’ sleep problems and insomnia-related interference with daily functioning from the Insomnia Severity Index (ISI).

Design/Methods Study 303 was a phase 3, 12mo, randomized, double-blind, global study. For 6mo (Period-1), subjects were randomized to PBO or LEM (5mg, [LEM5]; 10mg, [LEM10]). For the second 6mo (Period-2; reported separately), PBO subjects were rerandomized to LEM; LEM subjects remained on their assigned dose. A 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), was used to rate ISI items. A mixed-effect repeated measures model was used to evaluate least squares mean treatment differences (LSM-TD) for LEM vs PBO at 6mo.

Results

Mean (SD) baseline scores for ISI item “worried/distressed with sleep” were similar for PBO (2.9 [0.7]; n=312), LEM5 (3.0 [0.7]; n=312), and LEM10 (2.9 [0.8]; n=311). At 6mo, mean (SD) scores were decreased (improved) across all groups (PBO, 1.6 [1.0]; LEM5, 1.3 [1.1]; LEM10, 1.3 [1.0]). The LSM-TD (SE) was significantly greater vs PBO for LEM5 (−0.3 [0.1], P=0.001) and LEM10 (−0.3 [0.1], P<0.01).

Mean (SD) baseline scores for ISI item “interference with daily functioning” were similar for PBO (2.6 [0.8]; n=312), LEM5 (2.7 [0.7]; n=312), and LEM10 (2.6 [0.8]; n=311). At 6mo, mean (SD) scores were decreased across all groups (PBO, 1.5 [1.0]; LEM5, 1.2 [1.0]; LEM10, 1.2 [1.0]). The LSM-TD (SE) was significantly greater vs PBO for LEM5 (−0.4 [0.1], P<0.0001) and LEM10 (−0.3 [0.1]), P=0.0001).

Conclusions

Patient-perceived worry/distress about sleep problems and insomnia-related interference with daily functioning may be reduced with LEM.

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
	No disclosure on file
	No disclosure on file
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.