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

Phase 4 Completed 67 enrolled EMS Associação Fundo de Incentivo à Pesquisa · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2013-02-18
Primary completion: 2013-11-11
Completion: 2013-12-10

Publications

Castro LS, Otuyama LJ, Fumo-Dos-Santos C, Tufik S, Poyares D. Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial. Braz J Psychiatry. 2020 Apr;42(2):175-184. doi: 10.1590/1516-4446-2019-0389. Epub 2019 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zolpidem	Small molecule	5 mg	Subcutaneous
Subject	Zolpidem	Small molecule	10 mg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications