| Primary endpoint . | Mirtazapine group (n = 27) . | Placebo group (n = 30) . | Pa . | ||
|---|---|---|---|---|---|
| ISI 4-week change, mean [95% CI] | −6.5 [−8.3; −4,8]b | −2.9 [−4.4; −1.4]b | 0.003 | ||
| Secondary endpoints | |||||
| Baseline | Day 28 | Baseline | Day 28 | P c | |
| ISI, mean (SD) | 16.3 (4.0) | 9.0 (4.3) | 15.3 (3.3) | 12.5 (3.6) | 0.003 |
| PSQI, mean (SD) | 12.3 (3.3) | 7.2 (2.8) | 11.4 (3.1) | 7.8 (2.9) | 0.32 |
| Subjective sleep quality | 2.1 (0.6) | 1.2 (0.7) | 2.1 (0.5) | 1.8 (0.6) | |
| Sleep latency | 2.1 (1.0) | 1.5 (1.1) | 1.7 (1.1) | 1.5 (1.2) | |
| Sleep duration | 1.9 (0.9) | 1.0 (0.9) | 2.0 (1.0) | 1.6 (0.8) | |
| Sleep efficiency | 2.1 (1.2) | 1.4 (1.2) | 1.9 (1.2) | 1.4 (1.4) | |
| Sleep disturbance | 1.6 (0.6) | 1.1 (0.2) | 1.5 (0.5) | 1.0 (0) | |
| Use of sleeping medication | 1.5 (1.3) | 0 (0) | 1.4 (1.2) | 0 (0) | |
| Daytime dysfunction | 1.0 (0.9) | 1.0 (0.9) | 0.9 (0.7) | 0.9 (0.6) | |
| Subjective SOL minutes, mean (SD) | 43.9 (35.1) | 35.0 (30.9) | 53.6 (50.4) | 42.2 (32.1) | 0.46 |
| Subjective WASO number, mean (SD) | 2.8 (1.5) | 2.3 (1.3) | 2.5 (1.1) | 2.3 (1.2) | 0.91 |
| Subjective WASO minutes, mean (SD) | 89.9 (48.0) | 42.1 (24.6) | 84.7 (52.6) | 82.2 (74.9) | 0.021 |
| Subjective TST minutes, mean (SD) | 354.8 (75.4) | 425 (54) | 336.5 (83.7) | 362 (77) | 0.006 |
| Subjective sleep efficiency, mean (SD) | 0.68 (0.15) | 0.81 (0.08) | 0.66 (0.14) | 0.70 (0.16) | 0.003 |
| Objective WASO number, mean (SD) | 18.4 (8.0) | 21.7 (8.1) | 19.3 (8.3) | 21.2 (8.7) | 0.71 |
| Objective WASO minutes, mean (SD) | 92.2 (58.2) | 78 (45) | 77.8 (57.2) | 90 (61) | 0.53 |
| Objective TST minutes, mean (SD) | 373.7 (67.0) | 430 (58) | 395.8 (58.9) | 394 (59) | 0.07 |
| Objective sleep efficiency, mean (SD) | 0.80 (0.11) | 0.84 (0.08) | 0.83 (0.11) | 0.81 (0.10) | 0.34 |
| Primary endpoint . | Mirtazapine group (n = 27) . | Placebo group (n = 30) . | Pa . | ||
|---|---|---|---|---|---|
| ISI 4-week change, mean [95% CI] | −6.5 [−8.3; −4,8]b | −2.9 [−4.4; −1.4]b | 0.003 | ||
| Secondary endpoints | |||||
| Baseline | Day 28 | Baseline | Day 28 | P c | |
| ISI, mean (SD) | 16.3 (4.0) | 9.0 (4.3) | 15.3 (3.3) | 12.5 (3.6) | 0.003 |
| PSQI, mean (SD) | 12.3 (3.3) | 7.2 (2.8) | 11.4 (3.1) | 7.8 (2.9) | 0.32 |
| Subjective sleep quality | 2.1 (0.6) | 1.2 (0.7) | 2.1 (0.5) | 1.8 (0.6) | |
| Sleep latency | 2.1 (1.0) | 1.5 (1.1) | 1.7 (1.1) | 1.5 (1.2) | |
| Sleep duration | 1.9 (0.9) | 1.0 (0.9) | 2.0 (1.0) | 1.6 (0.8) | |
| Sleep efficiency | 2.1 (1.2) | 1.4 (1.2) | 1.9 (1.2) | 1.4 (1.4) | |
| Sleep disturbance | 1.6 (0.6) | 1.1 (0.2) | 1.5 (0.5) | 1.0 (0) | |
| Use of sleeping medication | 1.5 (1.3) | 0 (0) | 1.4 (1.2) | 0 (0) | |
| Daytime dysfunction | 1.0 (0.9) | 1.0 (0.9) | 0.9 (0.7) | 0.9 (0.6) | |
| Subjective SOL minutes, mean (SD) | 43.9 (35.1) | 35.0 (30.9) | 53.6 (50.4) | 42.2 (32.1) | 0.46 |
| Subjective WASO number, mean (SD) | 2.8 (1.5) | 2.3 (1.3) | 2.5 (1.1) | 2.3 (1.2) | 0.91 |
| Subjective WASO minutes, mean (SD) | 89.9 (48.0) | 42.1 (24.6) | 84.7 (52.6) | 82.2 (74.9) | 0.021 |
| Subjective TST minutes, mean (SD) | 354.8 (75.4) | 425 (54) | 336.5 (83.7) | 362 (77) | 0.006 |
| Subjective sleep efficiency, mean (SD) | 0.68 (0.15) | 0.81 (0.08) | 0.66 (0.14) | 0.70 (0.16) | 0.003 |
| Objective WASO number, mean (SD) | 18.4 (8.0) | 21.7 (8.1) | 19.3 (8.3) | 21.2 (8.7) | 0.71 |
| Objective WASO minutes, mean (SD) | 92.2 (58.2) | 78 (45) | 77.8 (57.2) | 90 (61) | 0.53 |
| Objective TST minutes, mean (SD) | 373.7 (67.0) | 430 (58) | 395.8 (58.9) | 394 (59) | 0.07 |
| Objective sleep efficiency, mean (SD) | 0.80 (0.11) | 0.84 (0.08) | 0.83 (0.11) | 0.81 (0.10) | 0.34 |
aANCOVA analysis.
bMean adjusted for baseline values.
cStudent t test.
SD: standard deviation CI: confidence interval ISI: insomnia severity index PSQI: Pittsburgh Sleep Quality Index, SOL: sleep onset latency, WASO: wake after sleep onset, TST: total sleep time.
| Primary endpoint . | Mirtazapine group (n = 27) . | Placebo group (n = 30) . | Pa . | ||
|---|---|---|---|---|---|
| ISI 4-week change, mean [95% CI] | −6.5 [−8.3; −4,8]b | −2.9 [−4.4; −1.4]b | 0.003 | ||
| Secondary endpoints | |||||
| Baseline | Day 28 | Baseline | Day 28 | P c | |
| ISI, mean (SD) | 16.3 (4.0) | 9.0 (4.3) | 15.3 (3.3) | 12.5 (3.6) | 0.003 |
| PSQI, mean (SD) | 12.3 (3.3) | 7.2 (2.8) | 11.4 (3.1) | 7.8 (2.9) | 0.32 |
| Subjective sleep quality | 2.1 (0.6) | 1.2 (0.7) | 2.1 (0.5) | 1.8 (0.6) | |
| Sleep latency | 2.1 (1.0) | 1.5 (1.1) | 1.7 (1.1) | 1.5 (1.2) | |
| Sleep duration | 1.9 (0.9) | 1.0 (0.9) | 2.0 (1.0) | 1.6 (0.8) | |
| Sleep efficiency | 2.1 (1.2) | 1.4 (1.2) | 1.9 (1.2) | 1.4 (1.4) | |
| Sleep disturbance | 1.6 (0.6) | 1.1 (0.2) | 1.5 (0.5) | 1.0 (0) | |
| Use of sleeping medication | 1.5 (1.3) | 0 (0) | 1.4 (1.2) | 0 (0) | |
| Daytime dysfunction | 1.0 (0.9) | 1.0 (0.9) | 0.9 (0.7) | 0.9 (0.6) | |
| Subjective SOL minutes, mean (SD) | 43.9 (35.1) | 35.0 (30.9) | 53.6 (50.4) | 42.2 (32.1) | 0.46 |
| Subjective WASO number, mean (SD) | 2.8 (1.5) | 2.3 (1.3) | 2.5 (1.1) | 2.3 (1.2) | 0.91 |
| Subjective WASO minutes, mean (SD) | 89.9 (48.0) | 42.1 (24.6) | 84.7 (52.6) | 82.2 (74.9) | 0.021 |
| Subjective TST minutes, mean (SD) | 354.8 (75.4) | 425 (54) | 336.5 (83.7) | 362 (77) | 0.006 |
| Subjective sleep efficiency, mean (SD) | 0.68 (0.15) | 0.81 (0.08) | 0.66 (0.14) | 0.70 (0.16) | 0.003 |
| Objective WASO number, mean (SD) | 18.4 (8.0) | 21.7 (8.1) | 19.3 (8.3) | 21.2 (8.7) | 0.71 |
| Objective WASO minutes, mean (SD) | 92.2 (58.2) | 78 (45) | 77.8 (57.2) | 90 (61) | 0.53 |
| Objective TST minutes, mean (SD) | 373.7 (67.0) | 430 (58) | 395.8 (58.9) | 394 (59) | 0.07 |
| Objective sleep efficiency, mean (SD) | 0.80 (0.11) | 0.84 (0.08) | 0.83 (0.11) | 0.81 (0.10) | 0.34 |
| Primary endpoint . | Mirtazapine group (n = 27) . | Placebo group (n = 30) . | Pa . | ||
|---|---|---|---|---|---|
| ISI 4-week change, mean [95% CI] | −6.5 [−8.3; −4,8]b | −2.9 [−4.4; −1.4]b | 0.003 | ||
| Secondary endpoints | |||||
| Baseline | Day 28 | Baseline | Day 28 | P c | |
| ISI, mean (SD) | 16.3 (4.0) | 9.0 (4.3) | 15.3 (3.3) | 12.5 (3.6) | 0.003 |
| PSQI, mean (SD) | 12.3 (3.3) | 7.2 (2.8) | 11.4 (3.1) | 7.8 (2.9) | 0.32 |
| Subjective sleep quality | 2.1 (0.6) | 1.2 (0.7) | 2.1 (0.5) | 1.8 (0.6) | |
| Sleep latency | 2.1 (1.0) | 1.5 (1.1) | 1.7 (1.1) | 1.5 (1.2) | |
| Sleep duration | 1.9 (0.9) | 1.0 (0.9) | 2.0 (1.0) | 1.6 (0.8) | |
| Sleep efficiency | 2.1 (1.2) | 1.4 (1.2) | 1.9 (1.2) | 1.4 (1.4) | |
| Sleep disturbance | 1.6 (0.6) | 1.1 (0.2) | 1.5 (0.5) | 1.0 (0) | |
| Use of sleeping medication | 1.5 (1.3) | 0 (0) | 1.4 (1.2) | 0 (0) | |
| Daytime dysfunction | 1.0 (0.9) | 1.0 (0.9) | 0.9 (0.7) | 0.9 (0.6) | |
| Subjective SOL minutes, mean (SD) | 43.9 (35.1) | 35.0 (30.9) | 53.6 (50.4) | 42.2 (32.1) | 0.46 |
| Subjective WASO number, mean (SD) | 2.8 (1.5) | 2.3 (1.3) | 2.5 (1.1) | 2.3 (1.2) | 0.91 |
| Subjective WASO minutes, mean (SD) | 89.9 (48.0) | 42.1 (24.6) | 84.7 (52.6) | 82.2 (74.9) | 0.021 |
| Subjective TST minutes, mean (SD) | 354.8 (75.4) | 425 (54) | 336.5 (83.7) | 362 (77) | 0.006 |
| Subjective sleep efficiency, mean (SD) | 0.68 (0.15) | 0.81 (0.08) | 0.66 (0.14) | 0.70 (0.16) | 0.003 |
| Objective WASO number, mean (SD) | 18.4 (8.0) | 21.7 (8.1) | 19.3 (8.3) | 21.2 (8.7) | 0.71 |
| Objective WASO minutes, mean (SD) | 92.2 (58.2) | 78 (45) | 77.8 (57.2) | 90 (61) | 0.53 |
| Objective TST minutes, mean (SD) | 373.7 (67.0) | 430 (58) | 395.8 (58.9) | 394 (59) | 0.07 |
| Objective sleep efficiency, mean (SD) | 0.80 (0.11) | 0.84 (0.08) | 0.83 (0.11) | 0.81 (0.10) | 0.34 |
aANCOVA analysis.
bMean adjusted for baseline values.
cStudent t test.
SD: standard deviation CI: confidence interval ISI: insomnia severity index PSQI: Pittsburgh Sleep Quality Index, SOL: sleep onset latency, WASO: wake after sleep onset, TST: total sleep time.
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