Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia

• Status: Completed
• Trial end date: 2013-12-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Collaborator: Associação Fundo de Incentivo à Pesquisa
• Treatments: Zolpidem

Criteria

Inclusion Criteria:

• Men or women aged between 20 and 64 years;

• Diagnosis of primary insomnia according to criteria defined by DSM-IV;

• Difficulty in maintaining sleep and waking up until 3 am;

• Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study;

• Signature of IC.

Exclusion Criteria:

• Previous history of serious medical illness, neurological or psychiatric disorder;

• Allergy or hypersensitivity to zolpidem;

• Obstructive Sleep Apnea syndrome;

• Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h;

• Other secondary sleep disorders;

• History of substance abuse or dependence;

• History of daily consumption of alcoholic beverages;

• Pregnancy, lactation or refusal to use safe contraceptive methods during the study.