Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder.
Status:
Not yet recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.