Assessment of Next-Morning Driving Performance After Middle of the Night Administration of Zolpidem Tartrate Sublingual Tablet 3.5 mg in Healthy Adult Volunteers: Single-center, Double-blind, Randomized, Placebo-controlled, Four-way Crossover Study.
Phase of Trial: Phase I
Latest Information Update: 01 Mar 2014
At a glance
- Drugs Zolpidem; Zopiclone
- Indications Insomnia
- Focus Adverse reactions; Registrational
- 15 Jul 2011 The US FDA has stated that it cannot confirm the safety of Zolpidem based on the resubmitted NDA, which included data from this trial.
- 20 Oct 2010 Status changed from recruiting to completed.
- 19 Oct 2010 Preliminary results presented in a Transcept Pharmaceuticals media release.