Table 4.

Analysis of LEM change from baseline in average SOL by M-MSLT (full analysis set)

	Placebo (n = 68)	LEM5 (n = 69)	LEM10 (n = 68)
Treatment difference in change from baseline in average SOL, min
LSM change from baseline (SE)	–3.44 (0.56)	–4.58 (0.56)	–6.92 (0.56)
LSM difference vs. placebo (lower bound of 95% CI)		–1.15 (–2.12)	–3.48 (–4.46)
1-sided p-valuea		0.0262	<0.0001

ap-Value vs. placebo using a mixed effects model, including treatment, period, and sequence as fixed effects, baseline (pre-dose) measurement as a covariate where applicable, and subject nested within-treatment sequence as a random effect.

If the lower bound of the one-sided 95% CI was –6.0 min or more, the dose was considered to have a clinically meaningful effect.

CI, confidence interval; LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; LSM, least squares mean; M-MSLT, Modified Multiple Sleep Latency Test; SE, standard error; SOL, sleep onset latency.