Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: zopiclone; zolpidem tartrate sublingual tablet; Placebo (sublingual tablet); Placebo
Intervention description: 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.; 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.; 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.; Placebo matching zopiclone
Intervention MeSH terms: Zolpidem; Zopiclone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: insomnia

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between the ages of 21 and 64 inclusive. For female subjects
             only: Female subjects will be included if they are post-menopausal or sterilized, or
             if they are of childbearing potential, they are not breastfeeding, their pregnancy
             test is negative, they have no intention of becoming pregnant during the course of the
             study, and are using adequate contraceptive drugs or devices. Medically acceptable
             methods of contraception that may be used by the subject and/or her partner are: oral
             contraceptives, progestin injection or implants, condom with spermicide, diaphragm
             with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or
             abstinence. Females using oral contraception must have started using the medication at
             least 4 weeks prior to screening. Surgical sterilization must have occurred at least 6
             weeks prior to screening.

          -  Good health on the basis of pre-study history and physical examination, vital signs
             and the results of blood chemistry, hematology, and urinalysis

          -  Good binocular visual acuity, corrected or uncorrected

          -  Possession of valid driver's license for 3 years or more

          -  Driving experience at least 3000 km/year

          -  Signed informed consent

        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:

               -  Affect sleep/wake function

               -  Prohibit the subject from completing the study

               -  Not be in the best interest of the subject to participate in the study