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

National Study, Phase IV, Single-center, Double-blind, Randomized, Parallel, Controlled by 10 mg Oral Zolpidem, in Evaluating the Efficacy and Safety of Zolpidem 5 mg Sublingual in the Induction and Maintenance of Sleep in Patients With Primary Insomnia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01896336

Enrollment

Registered

2013-07-11

Start date

2013-02-18

Completion date

2013-12-10

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Brief 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.

Detailed 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.

Interventions

DRUGZolpidem Hemitartrate

Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Efficacy will be measured by sleep induction and maintenance.	90 days	Sleep induction is measured by time to sleep after administration of the investigational product. The maintenance will be measured by the use of medication in the middle of the night and also by the elapsed time to sleep after administration of the investigational drug.

Secondary

Measure	Time frame	Description
Safety will be evaluated by the adverse events occurrences	90 days	Adverse events will be collected and followed in order to evaluate safety and tolerability

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026