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

Transcept Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Insomnia

Treatments: Drug: Placebo; Drug: zopiclone; Drug: zolpidem tartrate sublingual tablet; Drug: Placebo (sublingual tablet)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01106859

ZI-18

2010-019959-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

zopiclone

Active Comparator group

Description:

Zopiclone is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.

Treatment:

Drug: Placebo (sublingual tablet)

Drug: zopiclone

zolpidem 3 hours prior

Experimental group

Description:

A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet

zolpidem 4 hours prior

Experimental group

Description:

A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 4 hours prior to driving.

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet

Placebo

Placebo Comparator group

Description:

A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.

Treatment:

Drug: Placebo

Drug: Placebo (sublingual tablet)