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
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
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving performance will be measured by taking a standardized driving test.
Inclusion Criteria:
Exclusion Criteria:
A history of drug addiction or drug or substance abuse, including alcohol abuse, within the past 12 months
Has a history of restless legs syndrome, sleep apnea, narcolepsy or other primary sleep disorder
A known hypersensitivity to zolpidem or zopiclone
Has undergone oral surgery, tooth extraction or piercing of the lip/tongue within 60 days prior to screening
Has used any medication to promote sleep, including herbal medications, within 14 days (or 5 half-lives of the drug, whichever is longer) prior to screening
Prescription medications for other health conditions are allowed as long as the subject has been on a stable dose at least 30 days prior to screening
Has taken any drugs known to induce hepatic drug metabolism (i.e., rifampin) within 30 days prior to screening
BMI > 29 Kg/M^2
Current use of medication that affects driving performance
Smokes more than 10 cigarettes/day
Uses tobacco products during periods of nighttime awakening
Consumes more than 6 cups of coffee/day
Consumes more than 21 glasses of alcohol/week
Has received an investigational drug within 60 days or 5 half-lives (whichever is longer) prior to screening
Has any additional condition(s) that in the Investigator's opinion would: