Clinical trial NCT01106859: Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Keywords: insomnia
Lead sponsor: Transcept Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold
timeFrame: 3-9 hours post dose
measure: Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
timeFrame: 3-9 hours post dose
Secondary outcomes:
measure: Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test
timeFrame: 3-9 hours post dose
measure: Mean Standard Deviation of Speed (SDS) in the Highway Drive Test
timeFrame: 3-9 hours post dose
measure: Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)
timeFrame: Day 1 -6 weeks
measure: Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold
timeFrame: 3-9 hours post dose
measure: Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
timeFrame: 3-9 hours post dose
measure: Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold
timeFrame: 3-9 hours post dose
measure: Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
timeFrame: 3-9 hours post dose
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Annemiek Vermeeren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vermeeren A, Vuurman EF, Leufkens TR, Van Leeuwen CJ, Van Oers AC, Laska E, Rico S, Steinberg F, Roth T. Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use. Sleep. 2014 Mar 1;37(3):489-96. doi: 10.5665/sleep.3482.