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Halcion Side Effects, and Drug Interactions - Triazolam

Halcion Side Effects, and Drug Interactions - Triazolam

SIDE EFFECTS

During placebo-controlled clinical studies in which 1,003 patients received triazolam Tablets, the most troublesome side effects were extensions of the pharmacologic activity of triazolam, e.g. drowsiness, dizziness, or light-headedness.

The figures cited below are estimates of untoward clinical event incidence among subjects who participated in the relatively short duration (i.e., 1 to 42 days) placebo-controlled clinical trials of triazolam. The figures cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo, as each group of drug trials is conducted under a different set of conditions.

Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and nondrug factors to the untoward event incidence rate in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient while inducing it in others. (For example, an anticholinergic, anxiolytic drug may relieve dry mouth (a sign of anxiety) in some subjects but induce it (an untoward event) in others. (TABLE )1:

TABLE 1

% Patients Reporting
	Halcion	Placebo
Number of Patients	1003	997
Adverse REACTIONS
Central Nervous System
Drowsiness	14.0	6.4
Headache	9.7	8.4
Dizziness	7.8	3.1
Nervousness	5.2	4.5
Light-headedness	4.9	0.9
Coordination, disorders/ataxia	4.6	0.8
Gastrointestinal
Nausea/vomiting	4.6	3.7

In addition to the relatively common (i.e., 1% or greater) untoward events enumerated above, the following adverse events have been reported less frequently (i.e., 0.9% to 0.5%): euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, visual disturbances.

Rare (i.e., less than 0.5%) adverse reactions included constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, death from hepatic failure in a patient also receiving diuretic drugs.

In addition to these untoward events for which estimates of incidence are available, the following adverse events have been reported in association with the use of triazolam and other benzodiazepines: amnestic symptoms (anterograde amnesia with appropriate or inappropriate behavior), confusional states (disorientation, derealization, depersonalization, and/or clouding of consciousness), dystonia, anorexia, fatigue, sedation, slurred speech, jaundice, pruritus, dysarthria, changes in libido, menstrual irregularities, incontinence, and urinary retention. Other factors may contribute to some of these reactions, e.g. concomitant intake of alcohol or other drugs, sleep deprivation, an abnormal premorbid state, etc.

Other events reported include: paradoxical reactions such as stimulation, mania, an agitational state (restlessness, irritability, and excitation), increased muscle spasticity, sleep disturbances, hallucinations, delusions, aggressiveness, falling, somnambulism, syncope, inappropriate behavior and other adverse behavioral effects. Should these occur, use of the drug should be discontinued.

The following events have also been reported: chest pain, burning tongue/glossitis/stomatitis.

Laboratory analyses were performed on all patients participating in the clinical program for triazolam. The following incidences of abnormalities were observed in patients receiving triazolam and the corresponding placebo group. None of these changes were considered to be of physiological significance (TABLE 2):

TABLE 2

% of Patients Reporting
Number of Patients	Halcion 380		Placebo 361
Adverse REACTIONS	Low	High	Low	High
HEMATOLOGY
Hematocrit	*	*	*	*
Hemoglobin	*	*	*	*
Total WBC count	1.7	2.1	*	1.3
Neutrophil count	1.5	1.5	3.3	1.0
Lymphocyte count	2.3	4.0	3.1	3.8
Monocyte count	3.6	*	4.4	1.5
Eosinophil count	10.2	3.2	9.8	3.4
Basophil count	1.7	2.1	*	1.8
URINALYSIS
Albumin	-	1.1	-	*
Sugar	-	*	-	*
RBC/HPF	-	2.9	-	2.9
WBC/HPF	-	11.7	-	7.9
BLOOD CHEMISTRY
Creatinine	2.4	1.9	3.6	1.5
Bilirubin	*	1.5	1.0	*
SGOT	*	5.3	*	4.5
Alkaline phosphatase	*	2.2	*	2.6
* Less than 1%

When treatment with triazolam is protracted, periodic blood counts, urinalysis, and blood chemistry analyses are advisable. Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during therapy with triazolam and are of no known significance.

Drug Abuse and Dependence

Controlled Substance: Triazolam is a controlled substance under the Controlled Substance Act, and triazolam tablets have been assigned to Schedule IV.

Abuse, Dependence and Withdrawal: Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, dysphoria, perceptual disturbances and insomnia), have occurred following abrupt discontinuance of benzodiazepines, including triazolam. The more severe symptoms are usually associated with higher dosages and longer usage, although patients at therapeutic dosages given for as few as 1-2 weeks can also have withdrawal symptoms and in some patients there may be withdrawal symptoms (daytime anxiety, agitation) between nightly doses(see CLINICAL PHARMACOLOGY.) Consequently, abrupt discontinuation should be avoided and a gradual dosage tapering schedule is recommended in any patient taking more than the lowest dose for more than a few weeks. The recommendation for tapering is particularly important in any patient with a history of seizure.

The risk of dependence is increased in patients with a history of alcoholism, drug abuse, or in patients with marked personality disorders. Such dependence-prone individuals should be under careful surveillance when receiving triazolam. As with all hypnotics, repeat prescriptions should be limited to those who are under medical supervision.

DRUG INTERACTIONS

Both pharmacodynamic and pharmacokinetic interactions have been reported with benzodiazepines. In particular, triazolam produces additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistamines, ethanol, and other drugs which themselves produce CNS depression.

Pharmacokinetic interactions can occur when triazolam is administered along with drugs that interfere with its metabolism. Specific examples, documented with evidence from controlled trials, show that the co-administration of either cimetidine or erythromycin with triazolam causes an approximate doubling of the elimination half-life and plasma levels of triazolam. Consequently, consideration of dose reduction may be appropriate in patients treated concomitantly with either cimetidine or erythromycin and triazolam.

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