Table 3.
Summary of results for trial partner and clinician ratings
| Observed baseline mean (SD) | Observed week 4 mean (SD) | Model‐based LS mean change from baseline (95% CI)a | Difference in LS mean suvorexant versus Placebo | ||||
|---|---|---|---|---|---|---|---|
| Measure | Suvorexant | Placebo | Suvorexant | Placebo | Suvorexant | Placebo | (95% CI), p valuea |
| Partner's assessment of patient's sleep | |||||||
| sNTIBm, minb | 468.6 (116.4) | 449.0 (107.3) | 498.1 (107.8) | 477.2 (92.1) | 34.0 (20.0, 48.0) | 23.6 (9.8, 37.5) | 10.4 (−9.4, 30.1), 0.302 |
| sEARLIER, % yesc | ‐ | ‐ | 83 (64.3) | 87 (66.4) | ‐ | ‐ | OR 0.90 (0.52,1.57), 0.712 |
| sSQRm, 0–4 scaleb | 1.6 (0.7) | 1.6 (0.7) | 2.5 (0.8) | 2.3 (0.8) | 0.9 (0.7, 1.0) | 0.7 (0.5, 0.8) | 0.2 (0.0, 0.4),d 0.021 |
| SDI total, 0–12 scalec | 1.2 (1.2) | 1.0 (1.0) | 0.2 (0.5) | 0.3 (0.6) | −0.9 (−0.9, −0.8) | −0.7 (−0.8, −0.6) | −0.1 (−0.2, 0.0), 0.102 |
| Clinician's global impression of patient's insomnia severity | |||||||
| CGI‐S, 1–7 scalec | 4.1 (0.7) | 4.1 (0.8) | 2.6 (1.0) | 2.8 (1.2) | −1.5 (−1.7, −1.4) | −1.2 (−1.4, −1.0) | −0.3 (−0.6, −0.1), 0.010 |
| Partner's assessment of their own sleep quality | |||||||
| SSQC, 0–10 scaleb | 4.8 (2.2) | 4.5 (2.0) | 6.7 (2.2) | 6.5 (1.9) | 2.1 (1.7, 2.4) | 1.8 (1.5, 2.2) | 0.2 (−0.2, 0.7), 0.328 |
| Partner's assessment of their own distress | |||||||
| SDI distress, 0–5 scalec | 1.1 (0.7) | 1.0 (0.6) | 0.5 (0.4) | 0.5 (0.5) | −0.5 (−0.6, −0.4) | −0.5 (−0.6, −0.4) | −0.1 (−0.2, 0.1), 0.470 |
| NPI‐10 distress, 0–50 scalec | 6.6 (6.6) | 4.9 (4.2) | 4.7 (5.4) | 3.5 (3.6) | −1.7 (−2.5, −0.8) | −1.5 (−2.3, −0.7) | −0.1 (−1.3, 1.1), 0.841 |
| Partner's assessment of patient's neuropsychiatric symptoms | |||||||
| NPI‐10 total, 0–120 scalec | 4.4 (9.6) | 2.9 (5.5) | 3.0 (7.1) | 2.3 (5.3) | −1.2 (−1.9, −0.4) | −0.9 (−1.7, −0.2) | −0.2 (−1.3, 0.8), 0.651 |
Abbreviations: CGI‐S, clinical global impression of severity of insomnia; CI, confidence interval; LS, least squares;
NPI‐10, neuropsychiatric inventory 10‐Item version; OR, odds ratio; SD, standard deviation; SDI, sleep disorders inventory; sEARLIER, subjective report of whether the patient woke up earlier than planned (yes/no response); sNTIBm subjective nighttime time in bed (mean computed from daily assessments over week 4); SSQC, single‐item sleep quality scale—caregiver; sSQRm,; subjective sleep quality rating (mean computed from daily assessments over week 4).
For all measures except sEARLIER and NPI‐10, analyses are based on a longitudinal data analysis model with terms for baseline value, baseline severity category (MMSE score of 12 to 20, 21 to 26), age category (non‐elders, elders), sex, region, treatment, time point, and treatment‐by‐time point interaction as covariates. sEARLIER analysis is based on a generalized mixed‐effects model including terms for baseline value, baseline severity category (MMSE score of 12 to 20, 21 to 26), age (non‐elders, elders), sex, region, treatment, with treatment difference expressed as an odds ratio (OR). NPI‐10 analyses are based on an ANCOVA model including terms for baseline value, baseline severity category (MMSE score of 12 to 20, 21 to 26), age (non‐elders, elders), sex, region, and treatment. p values should be considered nominal.
For these endpoints a higher score indicates less impairment.
For these endpoints a lower score indicates less impairment.
Lower bound of 95% CI was >0; “0.0” is due to reporting to 1 decimal place.
“‐“ not applicable.