Table 3. Insomnia Severity and Daily Functioning End Points at the End of Month 1a.
| End Point | Placebo (n = 208) | Zolpidem ER 6.25 mg (n = 263) | Lemborexant 5 mg (n = 266) | Lemborexant 10 mg (n = 269) |
|---|---|---|---|---|
| ISI Total Score (Items 1-7) | ||||
| Baseline, mean (SD)b | 19.4 (3.6) | 19.2 (3.5) | 18.9 (3.5) | 19.0 (3.3) |
| Month 1, mean (SD)c | 13.3 (5.4) | 11.0 (5.4) | 11.2 (5.4) | 11.1 (5.6) |
| Change from baseline, mean (SD)c | –6.1 (5.5) | –8.3 (6.0) | –7.8 (5.5) | –7.9 (5.9) |
| LSM treatment difference vs placebo (95% CI)c | NA | –2.3 (–3.3 to –1.3) | –1.9 (–2.9 to –1.0) | –2.1 (–3.1 to –1.1) |
| P valued | NA | <.001 | <.001 | <.001 |
| LSM treatment difference vs zolpidem (95% CI)c | NA | NA | 0.4 (–0.6 to 1.3) | 0.2 (–0.7 to 1.2) |
| P valued | NA | NA | .45 | .64 |
| ISI Daytime Functioning (Items 4-7) | ||||
| Baseline, mean (SD)b | 11.2 (2.4) | 11.1 (2.5) | 10.9 (2.4) | 10.8 (2.3) |
| Month 1, mean (SD)c | 7.3 (3.6) | 5.9 (3.4) | 6.1 (3.5) | 6.1 (3.6) |
| Change from baseline, mean (SD)c | –3.9 (3.6) | –5.2 (3.8) | –4.8 (3.6) | –4.8 (3.7) |
| LSM treatment difference vs placebo (95% CI)c | NA | –1.4 (–2.1 to –0.8) | –1.1 (–1.7 to –0.5) | –1.1 (–1.7 to –0.5) |
| P valued | NA | <.001 | .001 | .001 |
| LSM treatment difference vs zolpidem (95% CI)c | NA | NA | 0.3 (–0.3 to 0.9) | 0.3 (–0.3 to 0.9) |
| P valued | NA | NA | .23 | .27 |
Abbreviations: ER, extended release; ISI, Insomnia Severity Index; LSM, least squares mean; NA, not applicable.
a
Measured by the ISI.
b
Sample sizes were 208 for placebo, 263 for zolpidem ER 6.25 mg, 266 for lemborexant 5 mg, and 269 for lemborexant 10 mg.
c
Sample sizes were 198 for placebo, 244 for zolpidem ER 6.25 mg, 257 for lemborexant 5 mg, and 253 for lemborexant 10 mg.
d
P values were based on an analysis of covariance model, with age group (55-64 years and ≥65 years), region (North America and Europe), and treatment as factors and baseline ISI value as a covariate.