Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder

Summary

This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.

Timeline

Start

2014-12-13

Primary completion

2015-04-21

Completion

2015-04-21

Outcome

Missed primary endpoint

paper In contrast, decreases in average SOL with LEM5 (LSM difference vs. placebo -1.15 min; 1-sided p = 0.0262) and LEM10 (-3.48 min; p < 0.0001) did not meet the predefined threshold for a clinically meaningful effect PMID 37193566 ↗

paper CONCLUSIONS: In contrast to flurazepam, LEM5 and LEM10 did not show clinically meaningful mean increases in next-morning sleep propensity versus placebo. PMID 37193566 ↗

Publications

• Mayleben D, Rosenberg R, Pinner K, Hussein Z, Moline M. Assessment of morning sleep propensity with lemborexant in adults with insomnia disorder in a randomized, placebo-controlled crossover study. Sleep Adv. 2021 Jul 2;2(1):zpab011. doi: 10.1093/sleepadvances/zpab011. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Flurazepam	Small molecule	30 mg	Oral
Subject	Lemborexant	Small molecule	5 mg	Oral
Subject	Lemborexant	Small molecule	10 mg	Oral

Indications