Triazolam Side Effects

Brand Names: Halcion

Please note - some side effects for Triazolam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Triazolam - for the Consumer

Triazolam

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Triazolam:

Clumsiness or unsteadiness; daytime drowsiness; dizziness; fatigue; feeling of hangover; headache; lightheadedness; nausea; nervousness; sluggishness; unusual weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) aggressiveness; chest pain; fast heartbeat; hallucinations; increased anxiety; memory loss; mental or mood changes; new or worsening depression; shortness of breath; slurred speech; suicidal thoughts; unusual thoughts or behavior; urinary changes; vision changes; worsening trouble sleeping; yellowing of the eyes or skin.

Triazolam Side Effects - for the Professional

Triazolam

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, eg, 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.)

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% to0.5%): 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, eg, 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.

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.

Side Effects by Body System

Nervous system

Nervous system side effects have been common and have included drowsiness, dizziness, and headache most frequently and occur in approximately 8% to 14% of treated patients. Sleep disturbances, morning "hang-over" symptoms, hyperexcitability, confusion, amnesia, and ataxia have been observed. Anterograde amnesia and transient global amnesia have also been reported in association with triazolam therapy. Triazolam may cause a greater degree of sedation and psychomotor impairment in older patients than in younger patients. The reason for this increased sensitivity is most likely related to reduced plasma clearance.

Anterograde amnesia associated with triazolam therapy has been reported to occur in as many as 50% of psychiatric patients treated with very high doses of triazolam (2 mg nightly). The incidence of anterograde amnesia, however, appears to be lower at the doses generally used for insomnia.

While many reports have suggested that residual sedative effects and impairment of psychomotor performance may occur, some studies have not supported these observations.

Cases of seizures associated with use of triazolam have also been reported.

One study has reported that triazolam significantly impairs standing steadiness one and two hours after drug administration.

Psychiatric

The frequency and extent to which triazolam therapy is associated with adverse behavioral effects is controversial.

One study based on the postmarketing surveillance Spontaneous Reporting System of the FDA has suggested that adverse behavioral reactions have been reported 22 to 99 times more frequently in association with triazolam therapy than with temazepam therapy for insomnia. An increased frequency of adverse behavioral effects was noted to occur most frequently in elderly patients and at higher doses of triazolam. The methodology of this study, however, has been questioned on the grounds that spontaneous reports of adverse effects do not necessarily correlate with the incidence of adverse effects.

Other studies and reports have concluded that little evidence exists to support the contention that triazolam therapy is associated with a greater risk of adverse behavioral effects than other benzodiazepines (including temazepam).

Psychiatric side effects have been reported in association with triazolam therapy which have included confusion, amnesia, bizarre behavior (including acts of violence), aggressiveness, agitation, depression, anxiety, paranoia, secondary mania, and hallucinations.

Other

Other side effects have included tolerance to the pharmacologic effects of triazolam and withdrawal symptoms after either abrupt cessation or fast tapering of triazolam may occur. Withdrawal symptoms have included agitation, restlessness, anxiety, insomnia, psychosis, delirium, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Rebound insomnia (a worsening of sleep following cessation of therapy), has been observed and has sometimes been reported to occur in association with increased daytime anxiety.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been reported rarely.

Respiratory

One study of patients with obstructive sleep apnea has suggested that triazolam may increase the maximum apnea duration and lower the minimum oxygen saturation of apneic patients.

Respiratory side effects including respiratory depression (after even small doses of triazolam) have been reported rarely. A case of noncardiogenic pulmonary edema has also been reported.

Local

Local side effects have included a case of intra-arterial injection of triazolam. In that case, a known intravenous drug abuser crushed oral triazolam tablets and injected them into the femoral artery. Distal necrosis ensued and resulted in the death of the patient.

Hepatic

Hepatic side effects have included a case of fatal intrahepatic cholestasis circumstantially associated with triazolam therapy.

Ocular

Ocular side effects have included cases of photic maculopathy which have been reported rarely in association with triazolam therapy.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.