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

NCT ID: NCT01106859

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-09-30

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

zopiclone

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

Group Type: ACTIVE_COMPARATOR

zopiclone

Intervention Type: DRUG

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.

Placebo (sublingual tablet)

Intervention Type: DRUG

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.

zolpidem 3 hours prior

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.

Group Type: EXPERIMENTAL

zolpidem tartrate sublingual tablet

Intervention Type: DRUG

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

Intervention Type: DRUG

Placebo matching zopiclone

zolpidem 4 hours prior

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.

Group Type: EXPERIMENTAL

zolpidem tartrate sublingual tablet

Intervention Type: DRUG

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

Intervention Type: DRUG

Placebo matching zopiclone

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo (sublingual tablet)

Intervention Type: DRUG

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

Intervention Type: DRUG

Placebo matching zopiclone

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

Placebo matching zopiclone

Intervention Type: DRUG

Other Intervention Names

non-benzodiazepine hypnotic agent; Zimovane; Imovane; Intermezzo®

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Transcept Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annemiek Vermeeren, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 24587571 (View on PubMed)

Other Identifiers

2010-019959-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZI-18

Identifier Type: -

Identifier Source: org_study_id