Current Scheduling Status
None
Year(s) and type of review / ECDD meetings
Drug Class
Recommendation (from TRS)
Substance identification
Acecarbromal (INN, CAS 77-66-7) chemically, N-[(acetylamino) carbonyl]-2-bromo-2-ethylbutanamide, is also known as acetcarbromalum (NFN), acetylcarbromal and sedacetyl. No isomeric forms are possible.
Similarity to known substances and effects on the CNS
Acecarbromal has been classified as a non-barbiturate sedative—hypnotic with a profile similar to that of glutethimide. In single doses the substance produces barbiturate-like sedative—hypnotic effects. Dose-related drowsiness, vertigo, confusion, and motor incoordination can occur. After prolonged use, the pharmacological profile becomes more like that of bromide ion. Chronic bromism leads to signs and symptoms such as loss of memory, confusion, inability to concentrate, hallucinations (both transitory and prolonged), delusions, and delirium, which often occur in other severe psychiatric disturbances. Indeed, until bromism was recognized as a toxicological syndrome, it accounted for a large number of admissions to psychiatric hospitals. Acecarbromal, like the barbiturates, is metabolized by hepatic microsomal enzymes and probably stimulates the production of these enzymes. It should be pointed out that this may increase the range of toxicological effects, owing to the production of increasing amounts of bromide ion.
Dependence potential
There is no information on the ability of acecarbromal to produce physical or psychic dependence in either animals or human subjects in controlled laboratory studies. In recent animal studies carbromal (see Section 2.2.3), a similar substance, produced little barbituratelike physical dependence at doses limited by solubility. Self administration was marginal.
Actual abuse and or/evidence of likelihood of abuse
Significant abuse of the bromocarbamides was reported. in the Federal Republic of. Germany in the 1970s. Acecarbromal represented only a small portion of this abuse and at present poses no serious problem.to public health and social welfare. Fifty-eight countries submitted reports on acecarbromal, but no others reported a problem with the drug. The drug is subject to national control in three countries. No cases of illicit manufacture or traffic were reported.
Therapeutic usefulness
Acecarbromal has-been. used asa "sédative and a hypnotic, and in a variety of combination preparations. It appears to be marketed only in the Federal. Republic of Germany. The therapeutic use of this substance has been largely replaced by other more effective drugs. The Committee rated the therapeutic usefulness of acecarbromal as low.
Recommendation
On the basis of the available data concetning its pharmacological profile, dependence potential, and actual abuse, the Committee rated the likelihood of abuse of acecarbromal:as moderate. The degree of seriousness of the public health and social problems associated with the substance was found to be low, as was its therapeutic usefulness. The Committee found that there’ was insufficient evidence that acecarbromal is being, or is likely to be, abused so as to constitute a public health and social problem warranting the placing of the substance under international control. In the light of this assessment, the Committee did not recommend scheduling of the substance.
Acecarbromal (INN, CAS 77-66-7) chemically, N-[(acetylamino) carbonyl]-2-bromo-2-ethylbutanamide, is also known as acetcarbromalum (NFN), acetylcarbromal and sedacetyl. No isomeric forms are possible.
Similarity to known substances and effects on the CNS
Acecarbromal has been classified as a non-barbiturate sedative—hypnotic with a profile similar to that of glutethimide. In single doses the substance produces barbiturate-like sedative—hypnotic effects. Dose-related drowsiness, vertigo, confusion, and motor incoordination can occur. After prolonged use, the pharmacological profile becomes more like that of bromide ion. Chronic bromism leads to signs and symptoms such as loss of memory, confusion, inability to concentrate, hallucinations (both transitory and prolonged), delusions, and delirium, which often occur in other severe psychiatric disturbances. Indeed, until bromism was recognized as a toxicological syndrome, it accounted for a large number of admissions to psychiatric hospitals. Acecarbromal, like the barbiturates, is metabolized by hepatic microsomal enzymes and probably stimulates the production of these enzymes. It should be pointed out that this may increase the range of toxicological effects, owing to the production of increasing amounts of bromide ion.
Dependence potential
There is no information on the ability of acecarbromal to produce physical or psychic dependence in either animals or human subjects in controlled laboratory studies. In recent animal studies carbromal (see Section 2.2.3), a similar substance, produced little barbituratelike physical dependence at doses limited by solubility. Self administration was marginal.
Actual abuse and or/evidence of likelihood of abuse
Significant abuse of the bromocarbamides was reported. in the Federal Republic of. Germany in the 1970s. Acecarbromal represented only a small portion of this abuse and at present poses no serious problem.to public health and social welfare. Fifty-eight countries submitted reports on acecarbromal, but no others reported a problem with the drug. The drug is subject to national control in three countries. No cases of illicit manufacture or traffic were reported.
Therapeutic usefulness
Acecarbromal has-been. used asa "sédative and a hypnotic, and in a variety of combination preparations. It appears to be marketed only in the Federal. Republic of Germany. The therapeutic use of this substance has been largely replaced by other more effective drugs. The Committee rated the therapeutic usefulness of acecarbromal as low.
Recommendation
On the basis of the available data concetning its pharmacological profile, dependence potential, and actual abuse, the Committee rated the likelihood of abuse of acecarbromal:as moderate. The degree of seriousness of the public health and social problems associated with the substance was found to be low, as was its therapeutic usefulness. The Committee found that there’ was insufficient evidence that acecarbromal is being, or is likely to be, abused so as to constitute a public health and social problem warranting the placing of the substance under international control. In the light of this assessment, the Committee did not recommend scheduling of the substance.
ECDD Recommendation
Scheduling/control not currently recommended
Link to full TRS
who_trs_761.pdf1.41 MB