Halcion Side Effects

Generic name: triazolam

Note: This document contains side effect information about triazolam. Some of the dosage forms listed on this page may not apply to the brand name Halcion.

Some side effects of Halcion may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to triazolam: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking triazolam (the active ingredient contained in Halcion) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling like you might pass out;

• staggering walk, loss of balance or coordination, very stiff (rigid) muscles;

• agitation, anxiety, confusion, slurred speech, hallucinations, feelings of extreme happiness or sadness;

• chest pain, fast or pounding heartbeats, feeling short of breath;

• problems with urination;

• vision problems, burning in your eyes; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Other common side effects may include:

• dizziness, tired feeling, daytime drowsiness (or during hours when you are not normally sleeping);

• headache, depressed mood, memory problems;

• numbness or tingly feeling;

• feeling nervous, excited, or irritable;

• changes in your menstrual periods;

• mild itching; or

• increased or decreased interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to triazolam: oral tablet

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 (the active ingredient contained in Halcion) 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 (the active ingredient contained in Halcion) 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 (the active ingredient contained in Halcion) 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 (the active ingredient contained in Halcion) 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 (the active ingredient contained in Halcion) 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 (the active ingredient contained in Halcion) therapy.

Ocular

Ocular side effects have included cases of photic maculopathy which have been reported rarely in association with triazolam (the active ingredient contained in Halcion) therapy.

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