Table 1.
Effects of 2 Weeks of Mirtazapine at Various Doses on Polysomnographic Variables and Daytime Sleepiness: Study 1
| Outcome variable | Baselinea | Placebob | Mirtazapine dose, mgb |
|||
|---|---|---|---|---|---|---|
| AHI, no./h | 7.5 | 15 | 30 | 45 | ||
| Total | 24.1 (8.0) | 25.0 (13.1–37.0) | 30.5 (20.1–41.0) | 37.3 (26.6–47.9)c | 39.2 (28.3–50.1)c | 26.7 (15.5–37.8) |
| Apneas only | 6.3 (6.8) | 13.2 (3.3–23.2) | 9.7 (0.8–18.6) | 12.9 (3.9–21.9) | 16.8 (7.7–26.0) | 9.9 (0.5–19.3) |
| Hypopneas only | 17.8 (6.3) | 12.4 (5.0–19.8) | 21.9 (16.0–27.9)c | 25.4 (19.3–31.6)d | 22.9 (16.6–29.2)c | 18.0 (11.1–24.8) |
| in REM | 36.6 (20.4) | 35.4 (21.6–49.1) | 39.7 (27.4–52.0) | 43.5 (31.0–55.9) | 46.4 (33.7–59.1) | 34.0 (21.0–47.0) |
| in NREM | 21.7 (9.2) | 23.3 (10.8–35.7) | 29.7 (18.7–40.6) | 37.4 (26.2–48.6)c | 38.8 (27.4–50.2)c | 24.9 (13.2–36.6) |
| AI, no./h | 23.6 (6.4) | 22.5 (13.6–31.4) | 29.5 (21.9–37.2) | 33.7 (25.9–41.5)c | 37.0 (29.0–45.1)c | 27.4 (19.2–35.7) |
| Sleep efficiency, % | 76.9 (9.4) | 82.6 (77.2–88.1) | 84.6 (80.2–89.1) | 83.9 (79.3–88.5) | 85.8 (81.0–90.6) | 85.1 (80.2–90.1) |
| Sleep stage, min | ||||||
| SWS | 51.8 (22.1) | 61.0 (33.9–88.2) | 62.3 (39.1–85.4) | 53.9 (30.2–77.6) | 54.4 (30.0–78.8) | 63.9 (38.7–89.0) |
| REM | 61.3 (21.1) | 72.5 (56.1–88.9) | 60.2 (46.7–73.8) | 72.4 (58.4–86.3) | 57.8 (43.3–72.2) | 67.3 (52.3–82.3) |
| 1&2 | 242.5 (47.4) | 250.0 (215.0–285.0) | 274.0 (245.7–302.3) | 260.0 (230.6–289.1) | 279.7 (249.3–310.1) | 259.9 (228.2–291.6) |
| ESS score | 13.6 (2.6) | 11.2 (8.5–13.8) | 10.6 (8.3–13.0) | 12.2 (9.8–14.6) | 12.3 (9.8–14.8) | 10.9 (8.4–13.4) |
a
Data are presented as the simple arithmetic mean (SD).
b
Data are presented as estimated means (95% confidence interval) using mixed-model estimates at the end of each treatment arm (with random patient effects and a fixed treatment effect).
c
P < 0.05 significantly worse than placebo.
d
P < 0.01 significantly worse than placebo. There were no significant order effects.
AHI refers to apnea-hypopnea index; REM, rapid eye movement sleep; NREM, non-rapid eye movement sleep; AI, Arousal Index; SWS, slow wave sleep; ESS, Epworth Sleepiness Scale.