Current Scheduling Status
Year(s) and type of review / ECDD meetings
Drug Class
Recommendation (from TRS)
Substance identification
Secbutabarbital (INN, CAS-125-40-6, and for the sodium salt CAS-143-81-7), chemically 5-sec-butyl-5-ethylbarbituric acid, is used therapeutically in the form of the sodium salt. Sodium 5-secbutyl-5-ethylbarbituric acid is also known as butabarbital (sodium), butabarbitone (sodium), and secumalnatrium.
Similarity to known substances and effects on the CNS
Secbutabarbital has been classified pharmacologically as an intermediate-acting sedative-hypnotic barbiturate with a profile similar to that of 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. The drug 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, can occur. Cross-tolerance may occur to other barbiturates, ethanol, and other sedative-hypnotic drugs.
Dependence potential
There is no information on the ability of secbutabarbital to induce physical dependence in either animals or man in controlled laboratory studies. In one study, rhesus monkeys trained to selfadminister thiamylal were given saline to extinguish responding; when responding was extinguished secbutabarbital reinstated responding. This indicates that the drug has reinforcing properties.
Actual abuse and or/evidence of likelihood of abuse
Secbutabarbital has been identified in urine samples of street drug users. Three countries reported cases of actual abuse, with one of them reporting only one case, the two others numerous cases. It is under national control in six countries. There have been reports of numerous seizures of legitimately produced substance as well as of trafficking of the formulated product. Cases of forged prescriptions have also been reported. There are no reports of any public health or social problems caused by this substance.
Therapeutic usefulness
Secbutabarbital is. used as a sedative and hypnotic and has the same efficacy -as other barbiturates in this regard. The drug or combination products containing it have been reported to be registered and/or available on the market in twelve countries. Over the past two years modest amounts of the drug have been consumed. The Committee rated the therapeutic usefulness of secbutabarbital as relatively low.
Recommendation
The Committee found that there was sufficient evidence, that
secbutabarbital 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 Convention on
Psychotropic Drugs. _ . ,
On the basis of its pharmacological profile, dependence potential, and evidence of actual abuse, the Committee rated the likelihood of abuse of secbutabarbital as moderate. The degree of the seriousness of the public health and social problems was also found to be moderate and its therapeutic usefulness relatively low. In the light of this assessment, the Committee recommended that secbutabarbital be placed in Schedule IV.
Secbutabarbital (INN, CAS-125-40-6, and for the sodium salt CAS-143-81-7), chemically 5-sec-butyl-5-ethylbarbituric acid, is used therapeutically in the form of the sodium salt. Sodium 5-secbutyl-5-ethylbarbituric acid is also known as butabarbital (sodium), butabarbitone (sodium), and secumalnatrium.
Similarity to known substances and effects on the CNS
Secbutabarbital has been classified pharmacologically as an intermediate-acting sedative-hypnotic barbiturate with a profile similar to that of 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. The drug 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, can occur. Cross-tolerance may occur to other barbiturates, ethanol, and other sedative-hypnotic drugs.
Dependence potential
There is no information on the ability of secbutabarbital to induce physical dependence in either animals or man in controlled laboratory studies. In one study, rhesus monkeys trained to selfadminister thiamylal were given saline to extinguish responding; when responding was extinguished secbutabarbital reinstated responding. This indicates that the drug has reinforcing properties.
Actual abuse and or/evidence of likelihood of abuse
Secbutabarbital has been identified in urine samples of street drug users. Three countries reported cases of actual abuse, with one of them reporting only one case, the two others numerous cases. It is under national control in six countries. There have been reports of numerous seizures of legitimately produced substance as well as of trafficking of the formulated product. Cases of forged prescriptions have also been reported. There are no reports of any public health or social problems caused by this substance.
Therapeutic usefulness
Secbutabarbital is. used as a sedative and hypnotic and has the same efficacy -as other barbiturates in this regard. The drug or combination products containing it have been reported to be registered and/or available on the market in twelve countries. Over the past two years modest amounts of the drug have been consumed. The Committee rated the therapeutic usefulness of secbutabarbital as relatively low.
Recommendation
The Committee found that there was sufficient evidence, that
secbutabarbital 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 Convention on
Psychotropic Drugs. _ . ,
On the basis of its pharmacological profile, dependence potential, and evidence of actual abuse, the Committee rated the likelihood of abuse of secbutabarbital as moderate. The degree of the seriousness of the public health and social problems was also found to be moderate and its therapeutic usefulness relatively low. In the light of this assessment, the Committee recommended that secbutabarbital 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