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Abstract Details

Efficacy and Safety of Lemborexant in Elderly Subjects with Insomnia Disorder: Pooled Analyses from SUNRISE-1 and SUNRISE-2
Sleep
P2 - Poster Session 2 (8:00 AM-9:00 AM)
5-012

Examine efficacy and safety of the dual orexin receptor antagonist lemborexant (LEM) treatment in subjects aged ≥65y.

In SUNRISE-1 (NCT02783729; E2006-G000-304) and SUNRISE-2 (NCT02952820; E2006-G000-303), LEM (5mg [LEM5];10mg [LEM10]) provided significant benefit on sleep onset and maintenance versus placebo, and was well tolerated. This pooled analysis of both studies examined outcomes from the subgroup of elderly subjects (age ≥65y) over 1 month.

SUNRISE-1 was a 1-month, double-blind, placebo- and active-controlled (zolpidem extended release; not reported here) study in subjects age ≥55y with insomnia disorder. SUNRISE-2 was a 12-month, double-blind study with a 6-month placebo-controlled period, then a 6-month active-only period. Subjects were ≥18y with insomnia disorder. Of 1006 and 949 subjects in the respective SUNRISE-1 and SUNRISE-2 full analysis sets, 595 (30.4%) were ≥65y (placebo, n=182; LEM5, n=205; LEM10, n=208). Here we analyzed change from baseline (CFB) in self-reported (subjective) sleep parameters in this subgroup using a mixed-effect repeated measurement analysis, adjusted for relevant factors.

At the end of 1 month, median subjective sleep onset latency (min) was significantly reduced from baseline with LEM versus placebo (placebo, −4.6; LEM5, −18.1; LEM10, −17.1; both P<0.0001). Subjective sleep efficiency (total sleep time/time in bed) significantly increased from baseline with LEM versus placebo (least squares mean [LSM] CFB: placebo, 6.1%; LEM5, 10.9%; LEM10, 12.5%; both P<0.001). Subjective wake after sleep onset was reduced from baseline with LEM versus placebo; the decrease with LEM10 was significant (LSM CFB: PBO, −24.1; LEM5, −34.5 [P=0.07], LEM10, −40.4 [P=0.0049]). Treatment-emergent adverse events with incidence >5% in either LEM group and >PBO in the PBO, LEM5, and LEM10 groups, respectively, were somnolence (1.1%, 6.5%, 13.1%) and headache (5.5%, 7.7%, 4.9%); no deaths occurred.

The observed efficacy and safety profile of LEM in this ≥65y subgroup supports its development as a potential treatment option for insomnia in the elderly.
Authors/Disclosures
Gary Zammit
PRESENTER 		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.
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
No disclosure on file
Dinesh Kumar Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
No disclosure on file
No disclosure on file
Carlos Perdomo (Eisai Inc.) No disclosure on file
No disclosure on file
Russell Rosenberg (Neurotrials Research) 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.