Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder.

NCT ID: NCT03885141

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-12-31

Brief Summary

Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.

Detailed Description

Information provided evidence for the therapeutic use of Zolpidem® in the treatment of insomnia. Several studies have emphasized the importance of using Zolpidem® in small doses, in the orodispersible form, in the treatment of insomnia. Accordingly, Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.

Conditions

Insomnia Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Men - Placebo

Men - Placebo, 1 tablet if a wake up occurs

Group Type: PLACEBO_COMPARATOR

Zolpidem

Intervention Type: DRUG

Zolpidem or Placebo if there is a wake up during the night

Men - Zolpidem 1.75 mg

Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

Zolpidem or Placebo if there is a wake up during the night

Men - Zolpidem 3.5 mg

Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

Zolpidem or Placebo if there is a wake up during the night

Women - Placebo

Women - Placebo, 1 tablet if a wake up occurs

Group Type: PLACEBO_COMPARATOR

Zolpidem

Intervention Type: DRUG

Zolpidem or Placebo if there is a wake up during the night

Women - Zolpidem 1.0 mg

Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

Zolpidem or Placebo if there is a wake up during the night

Women - Zolpidem 1.75 mg

Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

Zolpidem or Placebo if there is a wake up during the night

Interventions

Zolpidem

Zolpidem or Placebo if there is a wake up during the night

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men and women ≥ 18 years and ≤ 64 years of age

2. Participants willing and able to provide a written informed consent form, after an explanation of the nature of the study, and prior to any procedures related to the study.

3. Adults with clinical diagnosis of insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V-TR) and who complain of difficulty in maintaining sleep, starting more than three months before the study initiation, and for three or more sleepless nights per week.

4. Participants with ability to understand and willingness to comply with the study procedures

Exclusion Criteria

1. History of Allergy or Hypersensitivity to Zolpidem;

2. All initial and secondary insomnia;

3. Basal polysomnography with apnea and hypopnea index> 20 events / hour and PLM (Periodic Leg Movements)> 15 events / hour.

4. Participants who used central nervous system medication or other medication known to interfere with the sleep / wake up cycle within 15 days prior to enrollment in the study, at the discretion of the study investigator.

5. Clinically significant diseases or surgeries, at the discretion of the principal investigator, within 30 days prior to study inclusion.

6. History of chemical dependence or alcohol abuse.

7. Any significant neurological and psychiatric disease or laboratory findings present, unless adequately controlled with medication allowed in the protocol.

8. Participants who received any investigational medication in the last 12 months prior to study inclusion.

9. Women who are pregnant or breastfeeding or who wish to become pregnant or who refuse to use safe contraceptive methods during the study.

10. Any disorder of the circadian cycle.

11. Regular night shift work within the last 2 weeks prior to study enrollment or expected to work in shifts during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biolab Sanus Farmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Luciano R Pinto Junior, PhD

Role: CONTACT

lucianoribeiro48@gmail.com

55.11.973342037

Other Identifiers

ZOLP_18_01

Identifier Type: -

Identifier Source: org_study_id