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Etizolam (INN) Pre-Review Report

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Etizolam (INN) Pre-Review Report Etizolam (INN) Pre-Review Report Agenda item 5.7 Expert Committee on Drug Dependence Thirty-seventh Meeting Geneva, 16-20 November 2015 37th ECDD (2015) Agenda item 5.7 Etizolam Page 2 of 22 37th ECDD (2015) Agenda item 5.7 Etizolam Contents Acknowledgements ........................................................................................................................... 5 Summary ........................................................................................................................................... 6 1. Substance identification ................................................................................................................ 7 A. International Nonproprietary Name (INN)..................................................................................... 7 B. Chemical Abstract Service (CAS) Registry Number ....................................................................... 7 C. Other Names ................................................................................................................................... 7 D. Trade Names ................................................................................................................................... 7 E. Street Names ................................................................................................................................... 7 F. Physical properties ......................................................................................................................... 7 G. WHO Review History ...................................................................................................................... 7 2. Chemistry ....................................................................................................................................... 8 A. Chemical Name ............................................................................................................................... 8 B. Chemical Structure ......................................................................................................................... 8 C. Stereoisomers .................................................................................................................................. 8 D. Synthesis ......................................................................................................................................... 8 E. Chemical description ...................................................................................................................... 9 F. Chemical properties........................................................................................................................ 9 G. Chemical identification ................................................................................................................... 9 3. Ease of convertibility into controlled substances .......................................................................... 9 4. General pharmacology .................................................................................................................. 9 A. Pharmacodynamics......................................................................................................................... 9 B. Routes of administration and dosage............................................................................................ 12 C. Pharmacokinetics ......................................................................................................................... 12 5. Toxicology .................................................................................................................................... 13 6. Adverse reactions in humans ...................................................................................................... 14 7. Dependence potential ................................................................................................................... 15 A. Animal Studies .............................................................................................................................. 15 B. Human Studies .............................................................................................................................. 15 8. Abuse potential ............................................................................................................................. 15 A. Animal Studies .............................................................................................................................. 15 B. Human Studies .............................................................................................................................. 15 9. Therapeutic applications and extent of therapeutic use and epidemiology of medical use ...... 16 10. Listing on the WHO Model List of Essential Medicines ............................................................ 16 11. Marketing authorizations (as a medicinal product) ................................................................... 16 12. Industrial use ............................................................................................................................... 16 13. Non-medical use, abuse and dependence ................................................................................... 16 14. Nature and magnitude of public health problems related to misuse, abuse and dependence ................................................................................................................................... 17 15. Licit production, consumption and international trade ............................................................. 17 Page 3 of 22 37th ECDD (2015) Agenda item 5.7 Etizolam 16. Illicit manufacture and traffic and related information ............................................................ 17 17. Current international controls and their impact ........................................................................ 17 18. Current and past national controls ............................................................................................. 17 19. Other medical and scientific matters relevant for a recommendation on the scheduling of the substance ................................................................................................................................ 17 References ....................................................................................................................................... 18 Page 4 of 22 37th ECDD (2015) Agenda item 5.7 Etizolam Acknowledgements This report has been drafted under the responsibility of the WHO Secretariat, Essential Medicines and Health Products, Policy Access and Use team. This report has been drafted under the responsibility of the WHO Secretariat, Essential Medicines and Health Products, Policy Access and Use team. The WHO Secretariat would like to thank the following people for their contribution in producing this critical review report: Dr. Ed Pennings, Dr. Jan van Amsterdam and Dr. Jan Schoones, The Netherlands (literature search, review and drafting) and Dr. Stephanie Kershaw, Switzerland (editing). Page 5 of 22 37th ECDD (2015) Agenda item 5.7 Etizolam Summary Etizolam is a thienotriazolodiazepine and has pharmacological effects similar to those of the model benzodiazepine diazepam. It was developed in Japan and, at present, it is registered for use as a medicine in Japan, Italy, and India. Its main application is the treatment of generalized anxiety disorder with depressive symptoms. In this disorder, the therapeutic effect of etizolam (0.5 mg twice daily) is comparable to that of alprazolam (0.5 mg twice daily) and bromazepam (3 mg twice daily). At the recommended dose of 0.5 mg twice daily, etizolam appears to have minor effects on cognitive functioning. Etizolam acts on the benzodiazepine site of the GABAA receptor. In isolated neurons, etizolam behaved as a full benzodiazepine receptor agonist, similar to nitrazepam and diazepam. In laboratory animals, etizolam induced muscle relaxation, reduces conflict behaviour, and had anticonvulsive activity. Depending on the parameter and the animal studied, etizolam is about as active or up to six times as active as diazepam. In a drug discrimination study, etizolam fully substituted for pentobarbital and pretreatment with flumazenil shifted the dose-response curve to the right. In general, etizolam may cause similar adverse effects as the classical benzodiazepines, that is sedation, sleepiness, muscle relaxation, ataxia, slurred speech, and loss of consciousness. These effects are responsive to the GABAA-receptor antagonist flumazenil. Death by etizolam is rare. Only two cases have been described in the medical literature in which the concentration of etizolam in post-mortem blood indicate that etizolam may have contributed to death or was the likely cause of death. In animal studies, LD50 values for etizolam are 2-5 times higher (that is less lethality) than for diazepam. Studies on abuse and dependence liability barely exist. In a study with Rhesus monkeys, etizolam fully substituted for pentobarbital in drug discrimination procedures. In man, two cases of dependence have been described in the medical literature. Some publications and reports suggest that etizolam is increasingly misused in the USA and in Europe. Page 6 of 22 37th ECDD (2015) Agenda item 5.7 Etizolam 1. Substance identification A. International Nonproprietary Name (INN) Etizolam B. Chemical Abstract Service (CAS) Registry Number 40054-69-1 C. Other Names 6-(o-chlorophenyl)-8-ethyl-1-methyl-4H-s-triazolo[3,4-c]thieno[2,3-
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