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Halcion

Triazolam (marketed under brand names Halcion®, Novodorm®, Songar®) is a drug which is a benzodiazepine derivative. It possesses anxiolytic, anticonvulsant, sedative and skeletal muscle relaxant properties. more...

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History

In the past, triazolam was commonly prescribed to individuals who frequently changed time zones, such as business people and politicians travelling overseas. However, this practice has been discouraged, because these individuals would on occasion wake up with total amnesia and have no knowledge of where they were, or why they were there. In rare cases, paranoia would ensue.

Pharmacology

See Diazepam#Pharmacology.

Indications

Triazolam is commonly prescribed for insomnia because of its fast onset of action, and short half-life (approximately 3 hours). This makes it ideal for this use because it thereby avoids morning drowsiness.

Dosage

Dosages for triazolam are significantly lower than other benzodiazepines, and should be individualized depending on the needs of the patient. For insomnia, 0.125mg to 0.25mg are given at bedtime. Up to 0.5mg may be needed for resistent individuals. Dosage should never exceed 0.5mg.

Side Effects

See Diazepam#Side_Effects.

Interactions

See Diazepam#Interactions.

Contraindications

See Diazepam#Contraindications.

Overdose

See Diazepam#Overdose.

Safety

The safety of triazolam is questionable, because it has a fairly narrow therapeutic window. Also, evidence suggests long-term use (beyond 14 days) can cause hallucinations, amnesia, paranoia and aggressive behaviors. Also, like most other short acting benzodiazepines, it has a high potential for misuse, abuse and addiction.

Halcion belongs to the Pregnancy Category X of the FDA. This means that it is known to cause birth defects in the unborn baby. On October 2, 1991, the Committee on the Safety of Medicines (CSM) banned sales of Triazolam in the UK after concluding that it had a higher frequency of psychiatric side-effects than other hypnotics.

Legal Status

Internationally, triazolam is a Schedule IV drug under the Convention on Psychotropic Substances.

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European court upholds UK ban on Halcion
From British Medical Journal, 2/13/99 by Clare Dyer

The manufacturer of the sleeping pill triazolam (Halcion), banned from sale in the United Kingdom since 1993, has failed in its attempt to invoke European Community law to get the ban reconsidered.

The European Court of Justice in Luxembourg has held that the UK system for challenging drug bans by judicial review proceedings in the High Court complies with European Community law.

In judicial review cases, the court will not re-examine the evidence which led to the decision and substitute its own findings, but will look only at whether the decision was one which the administrative body could reasonably have reached based on the material before it.

The manufacturer of triazolam, Upjohn, lost its original challenge against the ban, which was imposed by the Medicines Control Agency, in the High Court in 1993. The court refused to refer the case to the European Court but the company appealed and the Court of Appeal agreed to refer three questions to the Luxembourg court.

After the drug's marketing licence was suspended in the United Kingdom in 1991, France and the Netherlands referred triazolam to the Committee for Proprietary Medicinal Products, made up of the European Community member states and the European Commission. The UK suspension continued until June 1993, when the Medicines Control Agency revoked the drug's licence. Three months later, the Committee for Proprietary Medicinal Products decided not to recommend a ban.

The European Court held that courts in member states were not under a duty to look at the scientific evidence and determine whether the decisions of drug licensing authorities were correct. It was enough for the court to verify that the authority's decision was not vitiated by error or misuse of power. The national courts do not have to take account of scientific evidence emerging after the original decision to ban the drug, the court ruled. If new material came to light, the company would be able to make a fresh application for marketing authorisation.

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