Current Scheduling Status
None
Year(s) and type of review / ECDD meetings
Drug Class
Recommendation (from TRS)
Substance identification
Bromisoval INN, CAS 496-67-3),1 chemically . (2-bromo-3-methylbutyrylurea, is also known as bromisovalum, bromisovalerylurea and bromvalerocarbamide. There is one chiral carbon atom in the molecule, so that two stereoisomers and one racemate are possible.
Similarity to known substances and effects on the CNS
Bromisoval has been classified as a non-barbiturate sedative hypnotic of the bromoureide class, which includes acecarbromal and carbromal. It produces barbiturate-like sedative and hypnotic effects, such as dose-related drowsiness, confusion and motor incoordination. The drug is debrominated during metabolism, and after prolonged use chronic bromism may occur, with such signs and symptoms as loss of memory,. confusion, inability to concentrate, hallucinations, delusions and delirium. Bromisoval, like the barbiturates, is metabolized mainly in the liver and is excreted in the bile as glutathione conjugates and in the urine as mercapturates.
Dependence potential
There is no information on the ability of bromisoval to produce physical or psychic dependence in either animals or human subjects in controlled laboratory studies. However, case reports of prolonged use of bromisoval indicate a possible barbiturate-like dependence potential, although this is probably less than that found with the barbiturates.
Actual abuse and or/evidence of likelihood of abuse
Cases of excessive, suicidal or prolonged use of bromisoval leading to poisoning and death have been reported in Belgium, the Federal Republic of Germany and Switzerland in the 1970s and 1980s. These cases may include abuse of bromisoval, but no illicit manufacture or traffic over the period 1985-1987 was mentioned in the reports that were obtained by INTERPOL, the United Nations Secretary-General and WHO from 54 countries and included in the critical review document submitted to the Expert Committee on Drug Dependence at its present meeting. This may indicate that serious public health or social problems of international scope resulting from abuse of the drug do not exist.
Therapeutic usefulness
Bromisoval has been used as a sedative and hypnotic, and in a variety of combination preparations, but the bromoureides have been replaced by newer agents in recent medical practice. It appears to be marketed in only a few countries.
Recommendation
On the basis of the available data concerning its pharmacological profile, dependence potential, and actual abuse, the Committee rated the likelihood of abuse of bromisoval as moderate and the therapeutic usefulness as low. Very few public health and social problems have been found to be associated with the substance, and the Committee considered that they were not serious enough to warrant the placing of the substance under international control. The Committee did not recommend scheduling of bromisoval.
Bromisoval INN, CAS 496-67-3),1 chemically . (2-bromo-3-methylbutyrylurea, is also known as bromisovalum, bromisovalerylurea and bromvalerocarbamide. There is one chiral carbon atom in the molecule, so that two stereoisomers and one racemate are possible.
Similarity to known substances and effects on the CNS
Bromisoval has been classified as a non-barbiturate sedative hypnotic of the bromoureide class, which includes acecarbromal and carbromal. It produces barbiturate-like sedative and hypnotic effects, such as dose-related drowsiness, confusion and motor incoordination. The drug is debrominated during metabolism, and after prolonged use chronic bromism may occur, with such signs and symptoms as loss of memory,. confusion, inability to concentrate, hallucinations, delusions and delirium. Bromisoval, like the barbiturates, is metabolized mainly in the liver and is excreted in the bile as glutathione conjugates and in the urine as mercapturates.
Dependence potential
There is no information on the ability of bromisoval to produce physical or psychic dependence in either animals or human subjects in controlled laboratory studies. However, case reports of prolonged use of bromisoval indicate a possible barbiturate-like dependence potential, although this is probably less than that found with the barbiturates.
Actual abuse and or/evidence of likelihood of abuse
Cases of excessive, suicidal or prolonged use of bromisoval leading to poisoning and death have been reported in Belgium, the Federal Republic of Germany and Switzerland in the 1970s and 1980s. These cases may include abuse of bromisoval, but no illicit manufacture or traffic over the period 1985-1987 was mentioned in the reports that were obtained by INTERPOL, the United Nations Secretary-General and WHO from 54 countries and included in the critical review document submitted to the Expert Committee on Drug Dependence at its present meeting. This may indicate that serious public health or social problems of international scope resulting from abuse of the drug do not exist.
Therapeutic usefulness
Bromisoval has been used as a sedative and hypnotic, and in a variety of combination preparations, but the bromoureides have been replaced by newer agents in recent medical practice. It appears to be marketed in only a few countries.
Recommendation
On the basis of the available data concerning its pharmacological profile, dependence potential, and actual abuse, the Committee rated the likelihood of abuse of bromisoval as moderate and the therapeutic usefulness as low. Very few public health and social problems have been found to be associated with the substance, and the Committee considered that they were not serious enough to warrant the placing of the substance under international control. The Committee did not recommend scheduling of bromisoval.
ECDD Recommendation
Scheduling/control not currently recommended
Link to full TRS
who_trs_775.pdf1.98 MB