A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Eszopiclone; Zopiclone

Criteria

Inclusion Criteria:

• Sign the informed consent form for the study;

• Be ≥ 20 to ≥ 64 years old;

• Have diagnosis of symptomatic primary insomnia for at least 3 months;

• Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;

• Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).

Exclusion Criteria:

• Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;

• Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;

• Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;

• Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;

• History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);

• History of substance abuse or dependence;

• Patients with severe co-morbidities (at the investigator's opinion);

• Presence of liver disorders, cirrhosis or liver failure;

• Presence of psychiatric disorders diagnosed at the adult life or currently under treatment;

• Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.