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Method for Assessing the Safety of Medications Used by Drivers: Example of Hypnotics

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. The Standard Driving Test: History. Developed in 1982 Standardized in 1984

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Method for Assessing the Safety of Medications Used by Drivers: Example of Hypnotics

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  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

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