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Triazolam is a brand name for Triazolam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam tablets are a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
Verbatim from this product's FDA label. Tap a section to expand.
25 mg once daily before bedtime. 125 mg once daily. 25 mg if no response. 25 mg once daily before bedtime. , patients with low body weight). 5 mg should be used only for patients who do not respond adequately to a trial of a lower dose.
5 mg once daily. Use the lowest effective dose for the patient as there are significant dose related adverse reactions. 6 )] . Prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply.
25 mg once daily. 125 mg once daily. 25 mg dose should be used only for patients who do not respond to a trial of the lower dose. 25 mg once daily. 5 )] . 3 Discontinuation or Dosage Reduction of Triazolam To reduce the risk of withdrawal reactions, use a gradual taper to discontinue triazolam or reduce the dosage.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. 3 )] .
11 )] Most common adverse reactions (incidence ≥4% and twice placebo) are drowsiness, dizziness, light-headedness, and coordination disorder/ataxia. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The incidences cited below are estimates of clinical reactions among 1,003 subjects who participated in the short term (duration of 1 to 42 days) placebo-controlled clinical trials of triazolam. Adverse reactions leading to discontinuation in two multi-dose placebo controlled clinical trials include coordination disorders, drowsiness, grogginess, somnolence, depression, restlessness, dizziness, lightheadedness, headache, nausea, visual disturbance, nervousness, abdominal distress, bladder trouble, aching limbs, backache, and blepharitis.
5%: euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, and visual disturbances. 5% include: constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, and death from hepatic failure in a patient also receiving diuretic drugs.
2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of triazolam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions:
5 WARNINGS AND PRECAUTIONS Persistent or Worsening Insomnia : Since 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. 4 ) "Sleep-driving" and Other Complex Behaviors : Complex behaviors such as "sleep-driving" have been reported.
The use of alcohol and other central nervous system (CNS) depressants with sedative-hypnotics appears to increase the risk, as well as doses exceeding the maximum recommended dose. 5 ) CNS Manifestations: An increase in daytime anxiety, abnormal thinking, and behavioral changes have been reported.
Emergence of any new behavioral changes require careful and immediate evaluation. 6 ) Effects on Driving and Operating Heavy Machinery: Patients receiving triazolam should be cautioned against driving or operating heavy machinery, as well as avoiding concomitant use with alcohol and other CNS depressant drugs.
7 ) Patients with Depression: Caution should be exercised in patients with signs or symptoms of depression that could be intensified by hypnotic drugs. Prescribe the least number of tablets feasible to avoid intentional overdose. 9 ) Neonatal Sedation and Withdrawal Syndrome : Triazolam use during pregnancy can result in neonatal sedation and/or neonatal withdrawal.
1 Risks From Concomitant Use With Opioids Concomitant use of benzodiazepines, including triazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs 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 triazolam 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.
4 CONTRAINDICATIONS Triazolam is contraindicated in: Patients with known hypersensitivity to triazolam, any of component of triazolam, or other benzodiazepines. Reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal.
1 )]. 8 , 17 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Paradoxical drug reaction, chest pain and fatigue Gastrointestinal disorders: Tongue discomfort, glossitis, stomatitis Hepatobiliary disorders: Jaundice Injury, poisoning and procedural complications: Fall Metabolism and nutrition disorders: Anorexia Nervous system disorders : Anterograde amnesia, altered state of consciousness, dystonia, sedation, syncope, dysarthria and muscle spasticity Psychiatric disorders: Confusional state (disorientation, derealisation, depersonalization), mania, agitation, restlessness, irritability, sleep disorder and libido disorder, hallucination, delusion, aggression, somnambulism, and abnormal behavior Renal and urinary disorders: Urinary retention and urinary incontinence Reproductive system and breast disorders: Menstruation irregular Skin and subcutaneous tissue disorders: Pruritis
In patients already receiving an opioid analgesic, prescribe a lower initial dose of triazolam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking triazolam, 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 triazolam is used with opioids. 1 )] . 2 Abuse, Misuse and Addiction The use of benzodiazepines, including triazolam, exposes users to the risks of abuse, misuse and addiction, which can lead to overdose or death.
2 )] . , using a standardized screening tool). Use of triazolam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of triazolam along with monitoring for signs and symptoms of abuse, misuse and addiction.
, opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. 3 )] . Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages and those who have had longer durations of use.
Acute Withdrawal Reactions The continued use of benzodiazepines, including triazolam, may lead to clinically significant physical dependence. 3 )] . 3 )] . 4 Persistent or Worsening Insomnia Since 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. , driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with triazolam use. 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 recommended dosages, the use of alcohol and other central nervous system (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. , 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, including triazolam.
As with sleep-driving, patients usually do not remember these events. 6 Central Nervous System Manifestations An increase in daytime anxiety has been reported for triazolam after as few as 10 days of continuous use. In some patients this may be a manifestation of interdose withdrawal.
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 triazolam.
, sedative/hypnotics). Other kinds of behavioral changes have also been reported, for example, bizarre behavior, agitation, hallucinations, depersonalization. 9 )] . Some adverse reactions reported in association with the use of triazolam such as drowsiness, dizziness, light-headedness, and amnesia appear to be dose related.
More serious behavioral phenomena such as confusion, bizarre or abnormal behavior, agitation, and hallucinations may also be dose related, but this evidence is inconclusive. 1 )] . 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. Anterograde amnesia of varying severity and paradoxical reactions have been reported following recommended dosages of triazolam.
Data from several sources suggest that anterograde amnesia may occur at a higher rate with triazolam than with other benzodiazepine hypnotics. Because triazolam can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.
Cases of "traveler's amnesia" have been reported by individuals who have taken triazolam to induce sleep while traveling, such as during an airplane flight. In some of these cases, insufficient time was allowed for the sleep period prior to awakening and before beginning activity.
Also, the concomitant use of alcohol may have been a factor in some cases. 7 Effects on Driving and Operating Heavy Machinery Due to 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 use of alcohol and other CNS depressant drugs during treatment with triazolam. 8 Triazolam Interaction With Drugs That Inhibit Metabolism via Cytochrome P450 3A The initial step in triazolam metabolism is hydroxylation catalyzed by CYP 3A.
Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of triazolam. 1 )] . Moderate and Weak CYP 3A Inhibitors Triazolam should be used with caution in patients receiving moderate or weak inhibitors of CYP 3A.
If coadministered, consider dose reduction of triazolam. 3 )] ; caution and consideration of appropriate triazolam dose reduction are recommended. Similar caution should be observed during coadministration with clarithromycin and other macrolide antibiotics.
3 )] ; caution and consideration of appropriate triazolam dose reduction are recommended. 9 Patients With Depression Benzodiazepines may worsen depression. , limiting the total prescription size and increased monitoring for suicidal ideation) should be considered in patients with depression .
1 )] . Monitor neonates exposed to triazolam during pregnancy or labor for signs of sedation and monitor neonates exposed to triazolam during pregnancy for signs of withdrawal; manage these neonates accordingly. 11 Compromised Respiratory Function In patients with compromised respiratory function, respiratory depression and apnea have been reported.
Closely monitor patients with compromised respiratory function. If signs and symptoms of respiratory depression or apnea occur, consider discontinuation.