Halcion

Triazolam comes as a tablet to take by mouth. It is usually taken as needed at bedtime, but not with or shortly after a meal. Triazolam may not work well if it is taken with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take triazolam exactly as directed.

You will probably become very sleepy soon after you take triazolam and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take triazolam and to stay in bed for 7 to 8 hours. Do not take triazolam if you will be unable to remain asleep for 7 to 8 hours after taking the medication. If you get up too soon after taking triazolam, you may experience memory problems.

Your sleep problems should improve within 7 to 10 days after you start taking triazolam. Call your doctor if your sleep problems do not improve during this time, if they get worse at any time during your treatment, or if you notice any changes in your thoughts or behavior.

Triazolam should normally be taken for short periods of time (usually 7 to 10 days). You should not take triazolam for more than 2 to 3 weeks without talking to your doctor. If you take triazolam for 7 to 10 days or longer, triazolam may not help you sleep as well as it did when you first began to take the medication, and you may wake up more easily during the last third of the night. You may also start to feel anxious or nervous during the day, and you may develop dependence ('addiction'; a need to continue taking the medication) on triazolam. Talk to your doctor about the risks of taking triazolam for 2 weeks or longer. Do not take a larger dose of triazolam, take it more often, or take it for a longer time than prescribed by your doctor.

If your doctor has told you to take triazolam regularly, talk to your doctor before you stop taking this medication. Your doctor will probably decrease your dose gradually. If you suddenly stop taking triazolam, you may develop unpleasant feelings or you may experience more severe withdrawal symptoms such as uncontrollable shaking of a part of the body, stomach and muscle cramps, vomiting, sweating, sad mood, seeing things or hearing sounds that do not exist, and rarely, seizures.

You may have more difficulty falling asleep or staying asleep on the first few nights after you stop taking triazolam than you did before you started taking the medication. This is normal and usually gets better without treatment after one or two nights.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with triazolam and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Common Side Effects of Triazolam

Tell your doctor if any of the following side effects become severe or don't go away:

• Daytime drowsiness, dizziness, or lightheadedness
• Unusual weakness
• Headache
• Coordination problems
• Nervousness
• Nausea
• Vomiting
• Tingling of the skin

Serious Side Effects of Triazolam

Tell your doctor right away if you experience any of the symptoms listed in the Triazolam Warnings section above, or any of the following serious side effects:

• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)
• Hoarseness
• Chest pain
• Shortness of breath
• Vision changes
• Urinary changes
• Yellowing of the skin or eyes

HALCION Tablets contain triazolam, a triazolobenzodiazepine hypnotic agent.

Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21.

The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α] [1,4] benzodiazepine.

The structural formula is represented below:

Each HALCION Tablet, for oral administration, contains 0.25 mg of triazolam. Inactive ingredients: 0.25 mg-cellulose, corn starch, docusate sodium, FD&C Blue No. 2, lactose, magnesium stearate, silicon dioxide, sodium benzoate.

Halcion is a prescription medicine used in adults for the short-term treatment (usually 7-10 days) of insomnia. It is not meant to be used by children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Grapefruit and grapefruit juice may interact with Halcion and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of Halcion for the treatment of short-term treatment of insomnia is 0.125 mg- 0.5 mg. A dose of 0.5 mg should not be exceeded.

Triazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) similar to Valium. Triazolam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Triazolam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Triazolam may also be used for other purposes not listed in this medication guide.

Some people using this medication have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking triazolam and talk with your doctor.

You should not use this medication if you are allergic to triazolam or similar medications, such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), flurazepam (Dalmane), or lorazepam (Ativan).

Sometimes it is not safe to use certain medications at the same time. The following drugs should not be used while you are taking triazolam:

• cimetidine (Tagamet);
• conivaptan (Vaprisol);
• nefazodone;
• an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);
• an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral); or
• medication to treat hepatitis C , HIV, or AIDS.

To make sure triazolam is safe for you, tell your doctor if you have any of these conditions:

• asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
• glaucoma;
• kidney or liver disease;
• myasthenia gravis; or
• a history of depression, drug or alcohol addiction, or suicidal thoughts or actions.

Triazolam may be habit forming. Never share triazolam with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use triazolam if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

It is not known whether triazolam passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medication.

The sedative effects of triazolam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking triazolam.

• Effects appear to be mediated through the inhibitory neurotransmitter GABA; the sites and mechanisms of action within the CNS appear to involve a macromolecular complex (GABAA-receptor-chloride ionophore complex) that includes GABAA receptors, high-affinity benzodiazepine receptors, and chloride channels.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule IV (C-IV) drug.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not take itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone (Serzone®), or certain HIV medicines (eg, indinavir, nelfinavir, lopinavir, ritonavir, saquinavir, Kaletra®, Norvir®). while you are using this medicine. Using these medicines together with triazolam may increase the chance of serious side effects.

Triazolam may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, nausea or vomiting, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth or throat while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while you are asleep or not fully awake. If these reactions occur, tell your doctor right away.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates (used for seizures), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, or less alert than they are normally. Even though triazolam is taken at bedtime, it may cause some people to feel drowsy or less alert the next morning. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to think or see well.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and have memory problems because the effects of the medicine have not had time to wear off.

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, sweating, tremors, vomiting, or unusual behavior.

If you develop any unusual and strange thoughts or behavior while you are taking triazolam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Change in the way you act.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Very bad dizziness.
• Change in balance.
• Feeling confused.
• Very nervous and excitable.
• A burning, numbness, or tingling feeling that is not normal.
• Feeling very tired or weak.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Halcion, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Halcion. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Halcion.

Review Date: October 4, 2017

Risks from Concomitant Use with Opioids

Concomitant use of benzodiazepines, including Halcion, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Halcion concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Halcion than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Halcion, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when Halcion is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Drug Interactions].

Persistent or Worsening Insomnia

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. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs. Because some of the important adverse effects of sedative-hypnotics appear to be dose related (see Precautions and Dosage and Administration), it is important to use the smallest possible effective dose, especially in the elderly.

"Sleep-driving" and Other Complex Behaviors

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviors, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a "sleep-driving" episode.

Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

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. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Halcion should not be rechallenged with the drug.

Central nervous system manifestations

An increase in daytime anxiety has been reported for Halcion after as few as 10 days of continuous use. In some patients this may be a manifestation of interdose withdrawal (see CLINICAL PHARMACOLOGY). If increased daytime anxiety is observed during treatment, discontinuation of treatment may be advisable.

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of benzodiazepine hypnotics including Halcion. Some of these changes may be characterized by decreased inhibition, eg, aggressiveness and extroversion that seem excessive, similar to that seen with alcohol and other CNS depressants (eg, sedative/hypnotics). Other kinds of behavioral changes have also been reported, for example, bizarre behavior, agitation, hallucinations, depersonalization. In primarily depressed patients, the worsening of depression, including suicidal thinking, has been reported in association with the use of benzodiazepines.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Because of its depressant CNS effects, patients receiving triazolam should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the concomitant ingestion of alcohol and other CNS depressant drugs during treatment with Halcion Tablets.

As with some, but not all benzodiazepines, anterograde amnesia of varying severity and paradoxical reactions have been reported following therapeutic doses of Halcion. Data from several sources suggest that anterograde amnesia may occur at a higher rate with Halcion than with other benzodiazepine hypnotics.

Triazolam interaction with drugs that inhibit metabolism via cytochrome P450 3A

The initial step in triazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP 3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of triazolam. Consequently, triazolam should be avoided in patients receiving very potent inhibitors of CYP 3A. With drugs inhibiting CYP 3A to a lesser but still significant degree, triazolam should be used only with caution and consideration of appropriate dosage reduction. For some drugs, an interaction with triazolam has been quantified with clinical data; for other drugs, interactions are predicted from in vitro data and/or experience with similar drugs in the same pharmacologic class.

The following are examples of drugs known to inhibit the metabolism of triazolam and/or related benzodiazepines, presumably through inhibition of CYP 3A.

Potent inhibitors of CYP 3A that should not be used concomitantly with triazolam include ketoconazole, itraconazole, nefazodone and several HIV protease inhibitors including ritonavir, indinavir, nelfinavir, saquinavir and lopinavir. Although data concerning the effects of azole-type antifungal agents other than ketoconazole and itraconazole on triazolam metabolism are not available, they should be considered potent CYP 3A inhibitors, and their coadministration with triazolam is not recommended (see CONTRAINDICATIONS).

Macrolide Antibiotics

Coadministration of erythromycin increased the maximum plasma concentration of triazolam by 46%, decreased clearance by 53%, and increased half-life by 35%; caution and consideration of appropriate triazolam dose reduction are recommended. Similar caution should be observed during coadministration with clarithromycin and other macrolide antibiotics.

Cimetidine

Coadministration of cimetidine increased the maximum plasma concentration of triazolam by 51%, decreased clearance by 55%, and increased half-life by 68%; caution and consideration of appropriate triazolam dose reduction are recommended.

Other drugs possibly affecting triazolam metabolism by inhibition of CYP 3A are discussed in the PRECAUTIONS section (see PRECAUTIONS–Drug Interactions).

Because of the potency of triazolam, some manifestations of overdosage may occur at 2 mg, four times the maximum recommended therapeutic dose (0.5 mg).

Manifestations of overdosage with Halcion Tablets include somnolence, confusion, impaired coordination, slurred speech, and ultimately, coma. Respiratory depression and apnea have been reported with overdosages of Halcion. Seizures have occasionally been reported after overdosages.

Death has been reported in association with overdoses of triazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including triazolam, and alcohol; benzodiazepine and alcohol levels seen in some of these cases have been lower than those usually associated with reports of fatality with either substance alone.

As in all cases of drug overdosage, respiration, pulse, and blood pressure should be monitored and supported by general measures when necessary. Immediate gastric lavage should be performed. An adequate airway should be maintained. Intravenous fluids may be administered.

Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS should be consulted prior to use.

Experiments in animals have indicated that cardiopulmonary collapse can occur with massive intravenous doses of triazolam. This could be reversed with positive mechanical respiration and the intravenous infusion of norepinephrine bitartrate or metaraminol bitartrate. Hemodialysis and forced diuresis are probably of little value. As with the management of intentional overdosage with any drug, the physician should bear in mind that multiple agents may have been ingested by the patient.

The oral LD50 in mice is greater than 1,000 mg/kg and in rats is greater than 5,000 mg/kg.

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0009-0017-58

Pfizer

Halcion®
triazolam
tablets, USP
CIV

0.25 mg

10 Tablets
Rx only

Applies to triazolam: oral tablet

General

Some side effects reported with triazolam (the active ingredient contained in Halcion) including drowsiness, dizziness, lightheadedness, and amnesia, appear to be dose related.[Ref]

Nervous system

Very common (10% or more): Drowsiness, sedation
Common (1% to 10%): Ataxia, concentration difficulty, dizziness, headache, impaired coordination, impaired equilibrium, lethargy, lightheadedness, tiredness
Uncommon (0.1% to 1%): Memory impairment
Frequency not reported: Amnestic symptoms (anterograde amnesia with appropriate or inappropriate behavior), clouding of consciousness, dysesthesia, dystonia, increased muscle spasticity, paresthesia, somnambulism, syncope, taste alteration, tinnitus, travelers amnesia[Ref]

Complex behaviors, such as "sleep-driving", other behaviors such as preparing and eating food, making phone calls, or having sex, with amnesia for these events, have been reported at therapeutic doses with this medicine.[Ref]

Psychiatric

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.

Withdrawal symptoms have included agitation, restlessness, anxiety, insomnia, psychosis, delirium, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Worsening of insomnia, depression, or the emergence of new thinking or behavior abnormalities, including suicidal thinking, have emerged during treatment with sedative-hypnotic drugs, including triazolam (the active ingredient contained in Halcion) 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).[Ref]

Common (1% to 10%): Anxiety, nervousness
Uncommon (0.1% to 1%): Confusional states, depression, euphoria
Frequency not reported: Abnormal dreams, acute rage, aggressiveness, agitation, bizarre behavior, delusions, dependence, depersonalization, derealization, disorientation in time or place, dysarthria, excitement, hallucinations, paranoia, hostility, nightmares, increased daytime anxiety, insomnia, sleep disturbances, stimulation, withdrawal syndrome[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia
Frequency not reported: Chest pain, palpitations[Ref]

Dermatologic

Frequency not reported: Angioneurotic edema, dermatitis, pruritus, skin alteration[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting
Frequency not reported: Burning tongue, constipation, diarrhea, dry mouth, glossitis, stomatitis[Ref]

Genitourinary

Frequency not reported: Changes in libido, incontinence, menstrual irregularities, urinary retention[Ref]

Hepatic

Frequency not reported: Jaundice[Ref]

Death from hepatic failure has been reported in a patient also receiving diuretic drugs.[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction, allergic edema, anaphylactic shock[Ref]

Metabolic

Frequency not reported: Anorexia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Pains/cramps[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbances[Ref]

Other

Frequency not reported: Congestion, falling, fatigue, weakness[Ref]

Respiratory

Frequency not reported: Hiccups, respiratory depression[Ref]

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.[Ref]

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.

Use should be avoided; use of this drug during lactation is contraindicated in Australia. Excreted into human milk: Unknown Excreted into animal milk: Yes

Little information is available on the use of triazolam during breastfeeding; an alternate short-acting hypnotic may be preferred (e.g., oxazepam or lorazepam), particularly when nursing a newborn or preterm infant. Because of its relatively short half-life, occasional use of triazolam during breastfeeding in an older infant should pose little risk; however, the infant should be monitored for excessive drowsiness.

Summary of Use during Lactation

Because little information is available on the use of triazolam during breastfeeding, an alternate hypnotic may be preferred, especially while nursing a newborn or preterm infant. Triazolam has a relatively short half-life, so occasional use while breastfeeding an older infant should pose little risk to the infant, but monitor the infant for excessive drowsiness.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

In a telephone follow-up study, 124 mothers who took a benzodiazepine while nursing reported whether their infants had any signs of sedation. One mother took triazolam while breastfeeding and reported no sedation in her infant.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Zaleplon, Zolpidem

References

1. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012;161:448-51. PMID: 22504099