Buthalital sodium

Current Scheduling Status
None
Year(s) and type of review / ECDD meetings
Drug Class

Recommendation (from TRS)

Substance identification
Buthalital sodium (INN, CAS-510-90-7), chemically 5-allyl-5-isobutyl-2-thiobarbituric acid sodium salt, is also known as butalital sodico, thialbutone sodium, thiobutone sodium, and buthalitone sodium.

Similarity to known substances and effects on the CNS
Buthalital sodium is classified as an ultra-short-acting barbiturate and was formerly used as an intravenous anaesthetic. No barbiturate of this type is currently scheduled. Dose-related drowsiness, vertigo, confusion, and incoordination can occur. The drug, like other barbiturates, is metabolized by hepatic microsomal enzymes and stimulates production of these enzymes.Buthalital sodium is a potent depressant of the central nervous system. It rapidly produces anaesthesia of a short duration. 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 specific information available on the ability of buthalital to induce physical or psychic dependence in either animals or man in controlled laboratory studies.

Actual abuse and or/evidence of likelihood of abuse
No cases of actual abuse, seizures, or production of the drug in clandestine laboratories have been reported. In five countries it is under national legislative control.

Therapeutic usefulness
Buthalital has been used as an anaesthetic agent. There is no indication that the drug is currently marketed. For its indicated use, the Committee rated the therapeutic usefulness of buthalital as high.

Recommendation
The Committee found that there was insufficient evidence that buthalital 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. On the basis of the limited data concerning its pharmacological profile, dependence potential, and actual abuse, the Committee rated the likelihood of abuse of buthalital as low. The degree of the public health and social problems associated with the drug was found to be low and its therapeutic usefulness high. In the light of this assessment, the Committee recommended against scheduling of the drug.

ECDD Recommendation

Scheduling/control not currently recommended