Abstract Details

Title Effect of Lemborexant Treatment on Polysomnographic Sleep Measures in Older Adults with Insomnia and Objective Short Sleep Duration

Topic Sleep

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

Poster/Presentation
Number 11-003

Objective To evaluate sleep parameters with lemborexant (LEM) versus zolpidem tartrate extended-release 6.25mg (ZOL) in subjects with insomnia and objective short-sleep duration (I-SSD), defined as total sleep time (TST) <6h.

Background There is evidence that patients with I-SSD may be less responsive to behavioral therapy for insomnia compared with insomnia patients with objectively longer, more normal sleep duration (TST ≥6h).

Design/Methods In Study E2006-G000-304 (NCT02783729), subjects (females age≥55y; males age≥65y) were randomized to LEM 5mg (LEM5) or 10mg (LEM10), placebo (PBO), or ZOL. Latency to persistent sleep (LPS) and wake after sleep onset (WASO) were assessed using polysomnograms and averaged. Change from baseline (paired polysomnograms during single-blind PBO run-in) was analyzed using mixed-effect model repeated measurement analysis for pooled Nights (NT)1/2 and NT29/30.

Results The I-SSD subgroup comprised 710/1006 (70.6%) subjects. Mean(SD) baseline LPS was similar across treatments in this subgroup: LEM5=54.28(39.30), LEM10=53.31(34.45), PBO=52.80(35.73), ZOL=54.77(40.93). At NT1/2, LEM5/LEM10 led to significant (P<0.05) decreases from baseline (LEM5=−22.02[31.62], LEM10=−25.42[34.73], PBO=−9.65[36.52], ZOL=−17.78[36.34]) versus PBO and ZOL. At NT29/30, LEM5/LEM10 led to significant (P<0.0005) decreases from baseline (LEM5=−25.37[37.06], LEM10=−28.20[34.75], PBO=−11.88[35.09], ZOL=−12.57[38.50]) versus PBO and ZOL, and LPS with ZOL was not different than PBO. Mean(SD) baseline WASO was similar across treatments: LEM5=128.14(37.52), LEM10=129.07(37.98), PBO=123.79(37.21), ZOL=128.37(38.94). At NT1/2, LEM5/LEM10 led to significant (P<0.0001) decreases from baseline (least squares mean[SE]: LEM5=−60.58[2.45]; LEM10=−69.35[2.41], PBO=−23.52[2.74], ZOL=−54.74[2.47]) versus PBO, and LEM10 was significantly different versus ZOL (P<0.0001). At NT29/30, LEM5/LEM10 led to significant (P<0.0001) decreases from baseline (LEM5=−52.67[2.74], LEM10=−55.37[2.70], PBO=−29.62[3.09], ZOL=−46.86[2.80]) versus PBO, and LEM10 decreases were significantly different versus ZOL (P<0.05).

Conclusions These results support LEM as an effective therapy for older patients with I-SSD and suggest LEM may be more beneficial than ZOL in these patients. Thus, LEM may be reasonably considered for treating older patients with I-SSD where behavioral therapy may have relatively limited efficacy.

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.
Andrew Krystal	Andrew Krystal has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome Therapeutics, Abbvie, Big Health, Eisai, Evecxia, Harmony Biosciences, Idorsia, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Neurocrine Biosciences, Neumora, Neurawell, Otsuka Pharmaceuticals, Sage, Takeda. Andrew Krystal has stock in Neurawell, Big Health. The institution of Andrew Krystal has received research support from Alkermes; Janssen Pharmaceuticals, Axsome Pharmaceutics, Attune, Eisai, Harmony, Neumora; Neurocrine Biosciences, Reveal Biosensors, The Ray and Dagmar Dolby Family Fund, Weill Institute for Neurosciences, and the National Institutes of Health.
Jack Edinger (National Jewish Health)	No disclosure on file
Dinesh Kumar	Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
Elizabeth Pappadopulos, PhD, RN (Eisai Inc)	Dr. Pappadopulos has received personal compensation for serving as an employee of Eisai Inc.

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