Abstract Details

Title Evaluation of Next-Dose Transition from Zolpidem to Lemborexant for the Treatment of Insomnia: A Multicenter Open-label Pilot Study

Topic Sleep

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

Poster/Presentation
Number 007

Background Studies that assess methods for transitioning patients between different insomnia medications are needed. E2006-A001-312 (Study 312; NCT04009577) was an open-label pilot study that examined pre-specified dosing approaches for transitioning from ZOL (immediate or extended-release) to LEM (5mg [LEM5] or 10mg [LEM10]).

Objective

Evaluate transition from zolpidem (ZOL) to lemborexant (LEM) in subjects with insomnia.

Design/Methods Adults with insomnia who were using only ZOL (self-reported intermittently [INT; 3-4 nights/week] or frequently [FREQ; ≥5 nights/week]) were enrolled. Following a 3-week Screening Period (subjects continued ZOL), eligible subjects entered the 2-week open-label Titration Period (TITR). Cohort 1 (LEM5) comprised subjects reporting INT in last 2 weeks of Screening, or INT and FREQ for 1 week each. Subjects reporting FREQ in last 2 weeks of Screening were in Cohort 2 and randomized (1:1) to LEM5 (2A) or LEM10 (2B). Following TITR, subjects electing to stay on LEM began the 12-week Extension Phase (EXT), followed by a 4-week Follow-up Period. During TITR and EXT, dose was flexible between LEM5 and LEM10. Proportion of subjects who transitioned to LEM following TITR was the primary endpoint.

Results Full Analysis Set included 53 subjects (Cohort 1, n=10; Cohort 2, n=43). Overall, 43 of 53 subjects (81.1%) transitioned to LEM. In Cohort 1, 10 subjects began TITR on LEM5; 9/10 (90.0%) transitioned, with 5 ending TITR on LEM5 and 4 on LEM10. In Cohort 2A, 21 subjects began TITR on LEM5; 17/21 (81.0%) transitioned, with 8 ending on LEM5 and 9 on LEM10. In Cohort 2B, 22 subjects began TITR on LEM10; 17/22 (77.3%) transitioned, with 3 ending on LEM5 and 14 on LEM10. Severity of all treatment-emergent adverse events was mild/moderate.

Conclusions Most subjects taking ZOL transitioned to LEM after TITR. All subjects who transitioned to LEM elected to continue LEM during EXT. LEM was well tolerated.

Authors/Disclosures
Russell Rosenberg (Neurotrials Research) PRESENTER	Mr. Rosenberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. The institution of Mr. Rosenberg has received research support from Neurotrials Research.
Dinesh Kumar	No disclosure on file
Carlos Perdomo (Eisai Inc.)	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.
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.