Abstract Details

Title Patient-reported Experiences Associated with Falling Asleep/Sleep Onset in an Open-label Study of Lemborexant and Zolpidem

Topic Sleep

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-003

Objective

Explore patient-reported experiences associated with falling asleep after taking zolpidem (ZOL) or lemborexant (LEM) in subjects who were frequent (≥5 nights/week) ZOL users.

Background Patients managing their insomnia with medication may need to change medications for reasons including inadequate clinical response or side effects. This open-label study examined transitioning patients with insomnia disorder from ZOL to (LEM 5mg (LEM5) or 10mg (LEM10). Information on patient experiences associated with sleep onset was collected to explore potential differences in how subjects felt while taking each medication.

Design/Methods Adults with insomnia who used ZOL intermittently (3-4 nights/week) or frequently were enrolled. The study design included a 3-week Screening Period (subjects continued ZOL) and a 2-week Titration Period (TITR). Cohort-2 included frequent ZOL users (randomized 1:1 to LEM5 or LEM10). The Sleep Drug Experience questionnaire was completed at end of Screening for ZOL and at end of TITR for LEM.

Results From Cohort-2, 38 subjects completed the questionnaire for ZOL and 35 subjects completed the questionnaire for LEM. Experiences during initial sleep onset endorsed by ≥50% of subjects for both ZOL and LEM, respectively, included: “drowsiness, grogginess, sleepiness” (76.3% vs 82.9%); “feeling relaxed/calm” (84.2% vs 85.7%); “falling asleep so quickly that you don't remember falling asleep” (68.4% vs 74.3%); “difficulty with remembering details of the night right before falling asleep” (60.5% vs 51.4%); “feeling sedated” (63.2% vs 60.0%); “dreams” (76.3% vs 80.0%); and “feeling peaceful” (65.8% vs 85.7%). Two experiences were reported by ≥50% of subjects for LEM only. These were “lightheadedness” (44.7% vs 51.4%) and “feeling of floating” (47.4% vs 57.1%) for ZOL and LEM, respectively.

Conclusions

The most frequently endorsed subject experiences during initial sleep onset were generally similar for ZOL and LEM. These results may be helpful in discussions between clinician and patient when discussing transitioning to lemborexant for insomnia.

Authors/Disclosures
Margaret Moline PRESENTER	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.
Dinesh Kumar	Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
	No disclosure on file

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