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Abstract Details

An Assessment of Wake Bouts in Adults with Insomnia Treated With Lemborexant or Zolpidem
Sleep
P4 - Poster Session 4 (8:00 AM-9:00 AM)
1-002
To evaluate the effect of lemborexant (LEM) on the frequency and duration of wake bouts (WB).

LEM is thought to promote sleep by inhibiting orexin-mediated wakefulness.

Study 304 (NCT02783729) was a 1mo, randomized, double-blind, PBO- and active-controlled (zolpidem tartrate extended-release 6.25mg [ZOL]) study of LEM 5mg (LEM5) and LEM 10mg (LEM10) in adults ≥55y with insomnia disorder (n=1006). Polysomnographic data from Night (NT)2 and NT31 of treatment were analyzed to determine the number and total duration of short (SWB; ≤2min) and long (LWB >2min) WB. P-values are based on differences among treatment groups in LSM changes from baseline in the number and total duration of WB.

LEM-treated subjects had more SWB during NT2 (LEM5[30.4]; LEM10[33.4]) versus PBO(26.9) or ZOL(26.3) and during NT31: 32.8, 34.7, 26.1, and 25.9, respectively. LEM5- and LEM10-treated subjects spent more minutes in SWB than PBO- or ZOL-treated subjects during NT2 (LEM5[22.0] [P<0.05 vs PBO and ZOL]; PBO[20.1]; and ZOL[19.5]; LEM10[24.5] [P<0.0001 vs PBO and ZOL]). Findings were similar during NT31 (LEM5[23.9]; LEM10[25.7] [both P<0.0001 vs PBO and ZOL]; PBO[19.4]; and ZOL[19.3]). ZOL was not significant versus PBO for total time spent in SWB at NT2 or NT31.

LEM-treated subjects had fewer LWB during NT2 (LEM5[4.7]; LEM10[4.4]) versus PBO(5.9) or ZOL(5.2). Numbers of LWB were similar during NT31: 5.1, 5.6, 5.5, and 5.2, respectively. LEM5- and LEM10-treated subjects spent fewer minutes in LWB than PBO- or ZOL-treated subjects during NT2 (LEM5[40.3]; LEM10[30.8] [both P<0.0001 vs PBO and ZOL]; PBO[73.0]; and ZOL[53.2]). Findings were similar during NT31: LEM5(42.5); LEM10(41.6) (both P<0.0001 vs PBO and ZOL); PBO(73.0); and ZOL(60.4). ZOL vs PBO was significant at NT2 and NT31 (both P<0.001).
Compared with PBO and ZOL, LEM treatment decreased the number and time spent in LWB, thereby decreasing wake time after sleep onset.
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.
Thomas Roth, PhD (Henry Ford Hospital) Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Roth has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Avadel. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz.
Gary Zammit Gary Zammit has received personal compensation for serving as an employee of Clinilabs, Inc.. Gary Zammit has received stock or an ownership interest from Clinilabs, Inc. Gary Zammit has received stock or an ownership interest from Sleep Disorders Institute. Gary Zammit has received stock or an ownership interest from Home Sleep and Respiratory Care.
Dinesh Kumar Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.