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Five Benzodiazepine Substances: Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam

The dramatic increase in trafficking and abuse associated with novel psychoactive substances (NPS) of the benzodiazepine class, also known as designer benzodiazepines, in the United States has become a national public health concern in recent years. The availability of NPS benzodiazepine substances in the illicit drug market continues to pose an imminent hazard to the public safety. The Centers for Disease Control and Prevention (CDC) highlights this issue in their Morbidity and Mortality Weekly Report (MMWR) published on August 27, 2021.^[3] CDC indicated that from April 2019 to June 2020 prescription and illicit benzodiazepine-involved overdose deaths increased by 21.8 percent and 519.6 percent respectively. Additionally, benzodiazepines were involved in nearly 7,000 overdose deaths in 23 states from January 2019 to June 2020, accounting for 17 percent of all drug overdose deaths. Adverse health effects associated with the abuse of such substances, their continued evolution, and increased popularity of these substances have been a serious concern in recent years.

The increase in the co-use of opioids with designer benzodiazepines has become a particular concern as the United States continues to experience an unprecedented epidemic of opioid misuse and abuse.^[4] CDC’s 2021 MMWR further states that between January and June 2020, 92.7 percent of benzodiazepine-involved deaths also involved opioids and 66.7 percent involved illicitly manufactured fentanyl. The combination of benzodiazepines with opioids substantially enhances the potential for lethality. Etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam are benzodiazepine substances recently identified on the illicit drug market in the United States. The abuse of etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam has been associated with fatalities in recent years in the United States. The positive identification of these five substances in post-mortem cases is a serious concern to the public safety. Additionally, law enforcement data indicate that the substances at issue here have significant presence in the illicit drug market found in the United States. In light of the law enforcement encounters and fatalities associated with the abuse of etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam, these substances pose an imminent hazard to public safety.

History and Current Pattern of Abuse

The chemical synthesis of etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam was previously reported in the scientific literature; however, the research did not lead to any medically approved products in the United States. Since 2012, synthetic drugs belonging to the benzodiazepine class have begun to emerge in the illicit drug market as evidenced by the identification of these drugs in forensic drug exhibits reported to the National Forensic Laboratory Information System (NFLIS-Drug) ^[5] and toxicology samples. Beginning in 2012, etizolam emerged on the illicit synthetic drug market as evidenced by its identification in drug seizures in the United States. In recent years, there has been a rise in the recreational use of etizolam. As evidenced by their identification in NFLIS-Drug, diclazepam emerged in the United States’ illicit drug market in 2014, flubromazolam and clonazolam in 2015, and flualprazolam in 2017. While these substances are not approved for medical use in the United States, etizolam is approved for medical use in Italy, India, and Japan.^[6] In a letter dated January 3, 2022, the Assistant Secretary informed DEA that there are no INDs or FDA-approved NDAs for etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam in the United States. Hence, there are no legitimate channels for these substances as marketed drug products in the United States. These five benzodiazepine substances are likely to be abused in the same manner as other sedative hypnotics. They have been identified in tablet form, as white to beige powders, or in liquid forms, typically of unknown purity or concentration. Based on data from NFLIS-Drug, law enforcement often encounters etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam in counterfeit pills, liquid, or powder form. Substances often found in combination with some of these benzodiazepines include substances of abuse such as heroin (schedule I), fentanyl (schedule II), substances structurally related to fentanyl, other benzodiazepines (both FDA-approved schedule IV benzodiazepines and other novel non-controlled benzodiazepines), and tramadol (schedule IV). Evidence suggests that individuals are using these substances to obtain “legal highs” ^[7] or to self-medicate. Information gathered from case histories and autopsy findings shows that deaths involving etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam were predominantly associated with poly-drug use.