Current Scheduling Status
Year(s) and type of review / ECDD meetings
Drug Class
Recommendation (from TRS)
Substance identification
Butobarbital (CAS-77-28-1), chemically 5-butyl-5-ethylbarbituric acid, is also known as butethal, butobarb, butobarbitalum, and butobarbitone. It is a racemic mixture.
Similarity to known substances and effects on the CNS
Butobarbital has been pharmacologically classified as an intermediate-acting sedative-hypnotic barbiturate with a profile similar to pentobarbital. As it is a hypnotic, it is presumed that dose related drowsiness, vertigo, confusion, and incoordination can occur. The drug, like other barbiturates, is metabolized by hepatic microsomal enzymes and stimulates the production of these enzymes. Butobarbital produces typical barbiturate-like sedative hypnotic effects on the central nervous system. As it is a hypnotic, it is presumed that tolerance, both natural and functional, may occur. Cross-tolerance may occur to other barbiturates, ethanol, and other sedative-hypnotic drugs.
Dependence potential
There is no specific information available on the ability of butobarbital to induce physical or psychic dependence, either in animals or man in controlled laboratory studies.
Actual abuse and or/evidence of likelihood of abuse
Belgium reported notable cases of abuse of preparations
containing butobarbital. The drug was also reported to be abused
23
in Nigeria. Minor cases of abuse were reported from Argentina, Czechoslovakia, and Hungary. New Zealand also reported a few suicides and one accidental death in the years 1982-85 associated with the abuse of the substance. No government reported any public health or social problems caused by this substance. Butobarbital is under national legislative control in twelve countries. There have been reports of illicit trafficking from three countries.
Therapeutic usefulness
Butobarbital was introduced as a hypnotic in 1931, and it continues to be used as a sedative-hypnotic in many countries. It is registered and/or is available on the market in 37 countries. Over the past two years, significant amounts of butobarbital have been sold in several countries. The Committee rated the therapeutic usefulness of butobarbital as relatively low.
Recommendation
The Committee found that there was sufficient evidence that butobarbital 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 Convention on Psychotropic Substances. On the basis of its pharmacological profile, dependence potential, and evidence of actual abuse, the Committee rated the likelihood of abuse of butobarbital as moderate. The degree of seriousness of the public health and social problems associated with its abuse was also found to be moderate and its therapeutic usefulness relatively low. In the light of this assessment, the Committee recommended that butobarbital be placed in Schedule IV.
Butobarbital (CAS-77-28-1), chemically 5-butyl-5-ethylbarbituric acid, is also known as butethal, butobarb, butobarbitalum, and butobarbitone. It is a racemic mixture.
Similarity to known substances and effects on the CNS
Butobarbital has been pharmacologically classified as an intermediate-acting sedative-hypnotic barbiturate with a profile similar to pentobarbital. As it is a hypnotic, it is presumed that dose related drowsiness, vertigo, confusion, and incoordination can occur. The drug, like other barbiturates, is metabolized by hepatic microsomal enzymes and stimulates the production of these enzymes. Butobarbital produces typical barbiturate-like sedative hypnotic effects on the central nervous system. As it is a hypnotic, it is presumed that tolerance, both natural and functional, may occur. Cross-tolerance may occur to other barbiturates, ethanol, and other sedative-hypnotic drugs.
Dependence potential
There is no specific information available on the ability of butobarbital to induce physical or psychic dependence, either in animals or man in controlled laboratory studies.
Actual abuse and or/evidence of likelihood of abuse
Belgium reported notable cases of abuse of preparations
containing butobarbital. The drug was also reported to be abused
23
in Nigeria. Minor cases of abuse were reported from Argentina, Czechoslovakia, and Hungary. New Zealand also reported a few suicides and one accidental death in the years 1982-85 associated with the abuse of the substance. No government reported any public health or social problems caused by this substance. Butobarbital is under national legislative control in twelve countries. There have been reports of illicit trafficking from three countries.
Therapeutic usefulness
Butobarbital was introduced as a hypnotic in 1931, and it continues to be used as a sedative-hypnotic in many countries. It is registered and/or is available on the market in 37 countries. Over the past two years, significant amounts of butobarbital have been sold in several countries. The Committee rated the therapeutic usefulness of butobarbital as relatively low.
Recommendation
The Committee found that there was sufficient evidence that butobarbital 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 Convention on Psychotropic Substances. On the basis of its pharmacological profile, dependence potential, and evidence of actual abuse, the Committee rated the likelihood of abuse of butobarbital as moderate. The degree of seriousness of the public health and social problems associated with its abuse was also found to be moderate and its therapeutic usefulness relatively low. In the light of this assessment, the Committee recommended that butobarbital be placed in Schedule IV.
ECDD Recommendation
Inclusion in Schedule IV of the 1971 Convention on Psychotropic Substances
Link to full TRS
who_trs_741.pdf2.21 MB