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U.S. Department of Health and Human Services

Safety

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Halcion (triazolam tablets)


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Sleep Disturbances
  • Severe Anaphylactic and Anaphylactoid Reactions

PRECAUTIONS

  • Information for Patients
    • "Sleep-driving" and other Complex Behaviors
    • Drug Interactions
      • Drugs that inhibit triazolam metabolism via cytochrome P450 3A:
      • Ketoconzaole
      • Itraconazole
      • Nefazodone
    • Tolerance/Withdrawal Phenomena

MEDICATION GUIDE (new)

WARNINGS

Sleep Disturbances

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated...

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedativehypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons...

Severe Anaphylactic and Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Halcion. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis...