TABLE OF CONTENTS

Technical Report Documentation Page

1. INTRODUCTION

1.1 Statement of The Problem

1.2 Limitations of Epidemiological Data

1.3 Clinical Pharmacology & Issue of Drug Choice

1.4 Prior Reviews of H 1 -antagonists

1.5 Focus of Current Review

2. METHOD

Reasons for Study Exclusion (Table 1)

The Ten Drugs Selected for Review (Table 2)

Number of Studies and Test Findings for each Skill Category and Subjective Sedation:
Acute and Repeated Dosing (Table 3)

3. RESULTS

3.1. Overall Impairment

3.2. Impairment by Individual Drugs as a Function of Acute Dose Level

3.3. Acute Dose Impairment by Behavioral Categories

3.3. 1. DRIVING AND PILOTING

3.3. 2. PSYCHOMOTOR SKILLS

3.3. 3. PERCEPTION

3.3. 4. VISUAL FUNCTIONS & CRITICAL FLICKER FUSION

3.3. 5. COGNITIVE TASKS

3.3. 6. DIVIDED ATTENTION

3.3. 7. VIGILANCE TASKS

3.3. 8. TRACKING

3.3. 9. REACTION TIME

3.3. 10. PHYSIOLOGICAL MEASURES OF SEDATION

4. SUMMARY AND DISCUSSION

5. CONCLUSIONS

REFERENCE LIST A
Articles Referenced in Report

REFERENCE LIST B
Articles Included in the Review

FIGURES

APPENDICES (PDF Format)

Appendix A - Tables of Impairment Findings by Behavioral Category (Tables 4-15)

Appendix B - Example of an Impairment Summary Sheet (YES/NO) by Behavioral Category

Appendix C - Example of a Study Summary Sheet (n=138 studies from 130 references)

Appendix D - Summary Table of Impairment Findings by Study (includes all 10 Drugs)

LIST OF TABLES

1. Reasons for Study Exclusion

2. The Ten Drugs Selected for Review

3. Number of Studies and Test Findings for each Skill Category and Subjective Sedation

4-14. Summary of Test Results by Behavioral Category (Appendix A)

Table 4. SUBJECTIVE MEASURES OF SEDATION

Table 5. DRIVING AND PILOTING

Table 6. PSYCHOMOTOR SKILLS

Table 7. PERCEPTION

Table 8. VISUAL FUNCTIONS & CRITICAL FLICKER FUSION

Table 9. COGNITIVE TASKS

Table 10. DIVIDED ATTENTION

Table 11. VIGILANCE TASKS

Table 12. TRACKING

Table 13. REACTION TIME

Table 14. PHYSIOLOGICAL MEASURES OF SEDATION


LIST OF FIGURES

(Appearing as a complete set of pdf's, separate from the report)

1.  Impairment Findings by Study for each Drug

2.  Impairment Findings as a Function of Objective/Subjective Measures and Drug Generation (Acute Doses Only)

3A. Dose Response Curves for Objective Measures

3B. Objective Measures: Impairment Findings by Drug and Generation

4A. Dose Response Curves for Subjective Measures

4B. Subjective Measures: Impairment Findings by Drug and Generation

5. Summary of Impairment Results for DRIVING/PILOTING

6. Summary of Impairment Results for PSYCHOMOTOR SKILLS

7. Summary of Impairment Results for PERCEPTION

8A. Summary of Impairment Results for VISUAL FUNCTIONS

8B. Summary of Impairment Results for CRITICAL FLICKER FUSION

9. Summary of Impairment Results for COGNITIVE TASKS

10. Summary of Impairment Results for DIVIDED ATTENTION

11. Summary of Impairment Results for VIGILANCE TASKS

12A. Summary of Impairment Results for TRACKING

12B. Summary of Impairment Results for CRITICAL & ADAPTIVE TRACKING

13. Summary of Impairment Results for REACTION TIME

14A. Summary of Sedation Results for PHYSIOLOGICAL MEASURES

14B. Summary of Sedation Results for MULTIPLE SLEEP LATENCY TESTS

15. Summary of Results across all Measures: OLD versus NEW Drugs