The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary endpoint at the end of the treatment, measured by polysomnography.~The secondary objectives and endpoints of this study are as follows:~To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints:~Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely:~Latency time to the beginning of the sleep;~Frequency of night wake-ups;~Time awake during bedtime;~Early morning awakening;~Total time in bed;~Sleep efficiency;~Sleep variables measured by actigraph;~Insomnia Severity Index (see Appendix B);45~Pittsburgh Sleep Quality Index (see Appendix C);46~To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.