Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Insomnia
Interventions
DRUG

zopiclone

7.5 mg tablet by mouth. Zopiclone is a commonly used hypnotic in Europe that is known to impair driving in the morning 9 hours after dosing.

DRUG

zolpidem tartrate sublingual tablet

3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

DRUG

Placebo (sublingual tablet)

Placebo matching zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

DRUG

Placebo

Placebo matching zopiclone

Trial Locations (1)

6229 ER

Maastricht University, Maastricht

Sponsors
All Listed Sponsors
lead

Transcept Pharmaceuticals

INDUSTRY

NCT01106859 - Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet | Biotech Hunter | Biotech Hunter