American and British Responses Diverge

Finally, in November 1991, the FDA approved new labeling for Halcion (Food and Drug Administration, 1992). The new label emphasizes that triazolam is indicated for short-term use and specifies 7-10 days. Treatment lasting longer than 2-3 weeks requires a complete reevaluation of the patient. In addition, the label emphasizes the use of the lowest possible dose. 

Following is the new warning on the Halcion label as found, for example, in the 1995 Physicians Desk Reference  

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of benzodiazepine hypnotics, 

As with some, but not all benzodiazepines, anterograde amnesia of varying severity and paradoxical reactions have been reported following therapeutic doses of HALCION. Data from several sources suggest that anterograde amnesia may occur at a higher rate with HALCION than with other benzodiazepine hypnotics. 

The final label change was negotiated and approved under the authority of Paul Leber, Director of the Division of Neuropharmacological Drug Products, the division responsible for Halcion s original approval. In several ways, the label seems to fall far short of conclusions generated by both the literature and the division responsible for postmarketing surveillance. 

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