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

EMS

Status and phase

Completed

Phase 4

Conditions

Primary Insomnia

Treatments

Drug: Zolpidem Hemitartrate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01896336

ZPDEMS1011

Details and patient eligibility

About

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.

Full description

National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral.
Experiment duration: 93 days.
05 visits (days -3, 0, 15, 45 and 90).
Efficacy will be evaluated for: Sleep induction and the maintenance of sleep.
Adverse events evaluation.

Enrollment

67 patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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.