Recommendation (from TRS)
Substance identification
Flubromazepam (IUPAC name: 7-bromo-5-(2- fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one) is a 1,4-benzodiazepine. Flubromazepam is described as a white powder or a crystalline solid and has been found in infused paper forms.
WHO review history
Flubromazepam has not been formally reviewed by WHO and is not currently under international control. Information was brought to WHO’s attention that this substance is manufactured clandestinely, poses a risk to public health and has no recognized therapeutic use.
Similarity to known substances and effects on the central nervous system
The chemical structure of flubromazepam is similar to that of other benzodiazepines, including phenazepam. Currently, there is insufficient information on the pharmacological profile of flubromazepam from controlled studies in experimental animals or humans to conclude that it has
effects that are similar to those of benzodiazepines that are controlled under the Convention on Psychotropic Substances of 1971.
Online self-reports by people who claim to have used flubromazepam describe sedative, muscle relaxant and euphoric effects and its use to self-manage benzodiazepine withdrawal. There are, however, no clinical reports to confirm such effects.
Dependence potential
No controlled study in experimental animals or humans have addressed the dependence potential of flubromazepam.
Actual abuse and/or evidence of likelihood of abuse
No studies in humans were found of the abuse liability of flubromazepam. People who self-report flubromazepam use describe euphoric effects and other benzodiazepine-like effects that would suggest it has a similar likelihood of abuse, but their use of flubromazepam cannot be confirmed.
Results from limited studies in experimental animals suggest abuse liability
Seizures have been reported in multiple countries across a number of regions. Although flubromazepam has been detected in several deaths and cases of driving under the influence of drugs, other drugs were also detected, and the contribution of flubromazepam was unclear.
Therapeutic use
Flubromazepam is not known to have any therapeutic use, is not listed on the WHO Model Lists of Essential Medicines and has never been marketed as a medicinal product.
Rationale and recommendation
Flubromazepam is a 1,4-benzodiazepine. Although it is chemically similar to other benzodiazepines listed under Schedule IV of the Convention on Psychotropic Substances of 1971, little information is available on its effects. Few studies in experimental animals and no studies in humans were found on
its effects or abuse potential. The limited information on its effects provides insufficient evidence to justify the placement of flubromazepam under international control.
The Committee recommended that flubromazepam (IUPAC name: 7-bromo-5-(2- fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one) be kept under surveillance by the WHO ECDD secretariat
ECDD Recommendation
Recommended for surveillance at 46th ECDD meeting (2023)
Flubromazepam is a 1,4-benzodiazepine. Although it is chemically similar to other benzodiazepines listed under Schedule IV of the Convention on Psychotropic Substances of 1971, little information is available on its effects. Few studies in experimental animals and no studies in humans were found on its effects or abuse potential. When reviewed by the ECDD, the limited information on its effects at that time provided insufficient evidence to justify the placement of flubromazepam under international control. The Committee recommended that flubromazepam be kept under surveillance by the WHO ECDD secretariat.