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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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Sleep aid safe when used carefully - Halcion
From FDA Consumer, 9/1/92

The prescription sleeping aid Halcion (triazolam) is safe and effective when used as the current labeling directs, according to FDA's Psychopharmacological Drug Products Advisory Committee. The committee also recommended further studies and labeling changes to address concerns about the drug's side effects.

For several years, critics have charged that Halcion had a higher frequency of psychiatric side effects--including memory loss and depression--than other sleep-aid drags. In November 1991, at FDA's request, Halcion's manufacturer, the Upjohn Company, agreed to make changes in the way it marketed Halcion to ensure that both patients and doctors were aware of the appropriate dosage and possible side effects. (See the Updates section of the March 1992 FDA Consumer.)

After evaluating current data on Halcion at its meeting last May 18, the FDA advisory committee has recommended:

* Upjohn should conduct further clinical trials to study Halcion's full possible dose range and the relationship of dose to side effects and effectiveness.

* The labeling should emphasize adequately that Halcion should only be used in low doses for a short time and that, although the standard adult dose is 0.25 milligrams, elderly patients or those who weigh 100 pounds or less should take a reduced dose of O. 125 milligrams. The labeling should also emphasize that in clinical trials, some patients experienced anxiety the day after taking Halcion.

* The patient package insert should be revised to include more easily understood guidance on using Halcion. Upjohn had previously revised the patient package insert to include explicit information about the drug's risks and benefits.

Upjohn announced that it plans to undertake a 10,000-patient clinical trial to compare the safety of Halcion with similar sleep aids.

FDA's advisory committees are composed of outside experts. Although their recommendations are not binding on the agency, they are given serious consideration in FDA's policy and actions.

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