1 / 9

Method for Assessing Driving Safety of Hypnotics: Standard Test & Hypnotic Series Study

Learn about the Standard Driving Test developed in 1982 and applied in over 45 studies to assess anxiolytics and hypnotics' safety, alongside the Hypnotic Series study evaluating residual sedation post-dosing in various subjects.

devin
Download Presentation

Method for Assessing Driving Safety of Hypnotics: Standard Test & Hypnotic Series Study

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Method for Assessing the Safety of Medications Used by Drivers: Example of Hypnotics James F. O’Hanlon, Ph.D. Staff Psychopharmacologist Tri-Counties Regional Center

  2. The Standard Driving Test: History • Developed in 1982 • Standardized in 1984 • Applied in > 45 major (published) studies with psychiatric and neurological patients, impaired elderly and healthy volunteers • Recognized as valid for assessing safety of anxiolytics and hypnotics by EMEA

  3. The Standard Driving Test: Method • Safety is supervised by instructor with access to redundant controls. • Subject operates instrumented vehicle over 100 km primary highway circuit in traffic. • Speed and lateral position are recorded. • Standard deviation of lateral position (SDLP) is the primary outcome variable.

  4. Hypnotic Series, 1982-98 • Purpose: evaluate residual sedation after sleep at times 5-17h post-dosing • Subjects: primary insomnia patients (DSM III-R), shiftworkers and healthy volunteers • Design: double-blind, placebo and active controlled, cross-over (N = 14-24) • Power: > 90% for detecting (p  .01) the same SDLP as for BAL = 0.5 mg/ml

  5. TRANSLATION OF SDLP DATA INTO PACKAGE LABELING FOR DRIVING HAZARD POTENTIAL Effect greater than BAC = 0.8 mg/ml or unknown Effect between BAC = 0.8 and 0.5 mg/ml Effect less than BAC = 0.5 mg/ml

More Related