To assess and compare efficacy and safety of Eszopiclone in patients suffering from insomnia.
Randomized, multicentric, comparative clinical trial.
Adult patients suffering from short-term/transient/chronic insomnia were enrolled after obtaining written informed consent and subjected to a washout (no drug) period for first 4 days followed by 7 days treatment with Eszopiclone 3 mg OD. After eszopiclone treatment, patients were randomly allocated to any one of the four drugs viz. zopiclone 7.5 mg OD, zolpidem 10 mg OD, zaleplon 10 mg OD and nitrazepam 5 mg OD for next 7 days. Patients were given patient diary cards for recording sleep parameters and were followed-up thrice, on day 5, day 12 and day 19 when assessment of improvement in sleep parameters and side-effect profile was done.
A total of 100 patients completed the study. Baseline total sleep time (minutes, mean ± SD) in the Eszopiclone 3 mg (n=100), Zopiclone 7.5 mg (n=27), Zaleplon 10 mg (n=24), Zolpidem 10 mg (n=23) and Nitrazepam 5 mg (n=26) treated groups increased significantly (P<0.001) from 327.5 ± 105.3 to 438.34 ± 105.3; 345.7 ± 98.03 to 454.71 ± 122.3; 291 ± 89.73 to 430.39 ± 76.73; 311 ± 125.8 to 441.12 ± 107.65 and 356.8 ± 99.21 to 456.68 ± 67.41 respectively. Baseline sleep latency time (minutes, mean ± SD) and number of awakenings (mean ± SD) in the Eszopiclone, Zopiclone, Zaleplon, Zolpidem and Nitrazepam treated groups decreased (P<0.001) from 117.15 ± 72.38 and 1.91 ± 1.1 to 36.89 ± 20 and 0.78 ± 0.65; 127.73 ± 59.03 and 1.61 ± 0.92 to 45.14 ± 24.86 and 0.77 ± 0.75; 108.13 ± 78.7 and 1.9 ± 1.04 to 40.95 ± 18.01 and 0.9 ± 0.56; 131.52 ± 95.18 and 2.25 ± 1.58 to 38.93 ± 26.43 and 0.89 ± 0.57; 101.78 ± 53.09 and 1.93 ± 0.7 to 34.12 ± 11.8 and 0.69 ± 0.64 respectively. There was no statistically significant (P>0.05) difference between-groups in improving total sleep time and sleep latency. The overall incidence of side-effects was: Eszopiclone (39%), Zopiclone (51.85%), Zolpidem (52.17%), Zaleplon (33.33%) and Nitrazepam (50%).
Eszopiclone was effective and comparable to other treatments in improving the sleep parameters in patients suffering from insomnia with better safety profile than Zopiclone, Zolpidem and Nitrazepam.
Eszopiclone, Insomnia, Efficacy, Safety
