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Halcion

Last reviewed on RxList: 5/15/2017
Halcion Side Effects Center

Last reviewed on RxList 05/12/2017

Halcion (triazolam) is a benzodiazepine used to treat insomnia symptoms, such as trouble falling or staying asleep. Halcion is available in generic form. Common side effects of Halcion include:

  • dizziness,
  • tiredness,
  • daytime drowsiness (or during hours when you are not normally sleeping),
  • loss of coordination,
  • headache,
  • depression,
  • memory problems,
  • numbness or tingly feeling,
  • nervousness,
  • excitability,
  • irritability,
  • changes in menstrual periods,
  • itching,
  • increased or decreased interest in sex, or
  • blurred vision.

Tell your doctor if you have serious side effects of Halcion including:

  • memory loss, or
  • mental/mood/behavior changes (such as new or worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, or anxiety).

Rarely, after taking Halcion, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking Halcion, tell your doctor right away.

The recommended dose of Halcion for most adults is 0.25 mg before retiring. Halcion may interact with birth control pills, cyclosporine, grapefruit juice, ranitidine, antibiotics, antidepressants, ergotamine, heart medications, or other medicines that make you sleepy (such as cold or allergy medicine, other sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). Tell your doctor all medications you use. Halcion must not be used during pregnancy. Other medications in this class cause birth defects when used in the first three months of pregnancy. Other medications in this class also cause drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used during pregnancy. Use birth control while taking this drug. Based on information from related drugs, Halcion may pass into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this drug is not recommended. Withdrawal symptoms may occur if this drug is abruptly stopped.

Our Halcion (triazolam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Halcion Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Halcion (Triazolam)

Halcion Professional Information

SIDE EFFECTS

During placebo-controlled clinical studies in which 1,003 patients received HALCION 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 HALCION. 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.)

Number of Patients % Patients Reporting: HALCION 1003 PLACEBO 997
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% 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 HALCION 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 HALCION. The following incidences of abnormalities were observed in patients receiving HALCION and the corresponding placebo group. None of these changes were considered to be of physiological significance.

Number of Patients % of Patients Reporting: HALCION 380 PLACEBO 361
Low High Low Hig
Hematology
Hematocrit * * * *
Hemoglobin * * * *
T otal 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
Albumi 1.1 *
Sugar * *
RBC/HPF 2.9 2.9
WBC/HPF Blood chemistry 11.7 7.9
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 HALCION 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 HALCION and are of no known significance.

Drug Abuse And Dependence

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Controlled Substance

Triazolam is a controlled substance under the Controlled Substance Act, and HALCION 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 HALCION. 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 HALCION. As with all hypnotics, repeat prescriptions should be limited to those who are under medical supervision.

Read the entire FDA prescribing information for Halcion (Triazolam)

Related Resources for Halcion

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