INSOMNIA
Conditions
Keywords
INSOMNIA, FOR THE TREATMENT OF INSOMNIA
Brief 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.
Detailed description
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.
Interventions
DRUGEszopiclone
Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
DRUGZopiclone
Zopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency to persistent sleep measured by polysomnography | 4 weeks | Determine whether eszopiclone is noninferior to the reference drug zopiclone (Imovane®) in the treatment of insomnia. The latency to persistent sleep will be used as a primary endpoint at the end of the treatment, measured by polysomnography |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency using the variables latency time to persistent sleep, frequency of night awakenings, time awake during bedtime, early morning awakening, total time in bed, total time awake and sleep efficiency | 6 weeks |
Countries
Brazil
Outcome results
None listed