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VOLUME 3 , ISSUE 1 ( January-March, 2008 ) > List of Articles

ORIGINAL ARTICLE

Results of a Multi-centric, Comparative Clinical Trial on Efficacy and Safety of Eszopiclone in Indian Patients

S Phadke, Jyoti Shetty

Keywords : Eszopiclone – Insomnia – Efficacy – Safety

Citation Information : Phadke S, Shetty J. Results of a Multi-centric, Comparative Clinical Trial on Efficacy and Safety of Eszopiclone in Indian Patients. Indian Sleep Med 2008; 3 (1):20-24.

DOI: 10.5005/ijsm-3-1-20

License: NA

Published Online: 01-06-2018

Copyright Statement:  NA


Abstract

Aim: To assess and compare efficacy and safety of Eszopiclone in patients suffering from insomnia. Design: Randomized, multicentric, comparative clinical trial. Materials and Methods: 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. Results: 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%). Conclusion: 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.


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  1. Silber MH 2005. Chronic Insomnia. N Engl J Med 353: 8- 25.
  2. Erman MK 2005. Therapeutic options in the treatment of insomnia. J Clin Psychiatry 66 Suppl 9:18-23; quiz 42-3.
  3. McMahon LR, Jerussi TP, France CP 2003. Steroselective discriminative stimulus effects of zopiclone in rhesus monkeys. Psychopharmacology 165: 222-228.
  4. Georgiev V 2001. (S)-Zopiclone. Curr Opin Invest Drugs 2(2):271-273.
  5. Leese P, Maier G, Vaickus L et al 2002. Esopiclone: Pharmacokinetic and pharmacodynamic effects of a novel sedative hypnotic after daytime administration in healthy subjects (abstract 061.C). Sleep 25(suppl):A45.
  6. Krystal AD, Walsh JK, Laska E, Caron J, Amato DA, Wessel TC, Roth T 2003. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep 26(7): 793-799.
  7. Roth T, Walsh JK, Krystal A, Wessel T, Roehrs TA 2005. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med 2005; 6(6): 487-95.
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