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.

Trial Profile

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.

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Mar 2014

At a glance

  • Drugs Zolpidem; Zopiclone
  • Indications Insomnia
  • Focus Adverse reactions; Registrational
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top