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Zolpidem Orodispersible in Maintenance Insomnia
NCT03885141Phase 3
Key facts
- Status
- Unknown
- Start
- Mar 2021
- Primary completion
- Dec 2021
- Sponsor
- Biolab Farmacêutica
- Modality
- Small Molecules
- Drugs
- zolpidem
- Conditions
- Sleep initiation and maintenance disorder
01
Overview
Phase 3, randomised, double-blind trial of zolpidem in Sleep initiation and maintenance disorder (6 arms), sponsored by Biolab Farmacêutica. Primary endpoint: Insomnia Severity Index at 28 days. Status: unknown.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Men - Placebo
Men receiving Placebo
Men - Zolpidem 1.75 mg
Men receiving Zolpidem 1.75 mg
Men - Zolpidem 3.5 mg
Men receiving Zolpidem 3.5 mg
Women - Placebo
Women receiving Placebo
Women - Zolpidem 1.0 mg
Women receiving Zolpidem 1.0 mg
Women - Zolpidem 1.75 mg
Women receiving Zolpidem 1.75 mg
03
Who it enrols
Adults 18-64 with DSM-V-TR diagnosis of maintenance insomnia disorder (>3 months duration).
04
Endpoints
Primary
Insomnia Severity Index
Secondary
Total Sleep Time
Sleep Efficiency
Sleep Latency
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