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More frequently reported side effects include: dizziness, insomnia, rebound insomnia, headache, and irritability. See below for a comprehensive list of adverse effects.For the Consumer
Applies to triazolam: oral tablet
Oral route (Tablet)
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosage and duration to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.
Along with its needed effects, triazolam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking triazolam:
Incidence not known
Some side effects of triazolam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
For Healthcare Professionals
Applies to triazolam: oral tabletGeneral
The most commonly reported side effects included drowsiness/sedation, dizziness/lightheadedness, headache, and ataxia.Nervous system
Very common (10% or more): Sedation (up to 19.4%), drowsiness (up to 14%)
Common (1% to 10%): Anterograde amnesia with appropriate/inappropriate behavior, ataxia, concentration difficulty, coordination disorders/impaired coordination, dizziness, headache, impaired equilibrium, lethargy, lightheadedness, memory impairment
Rare (0.01% to 0.1%): Dysesthesia, paresthesia, taste alterations
Frequency not reported: Amnestic symptoms, clouding of consciousness, dysarthria, dystonia, slurred speech, somnambulism, syncope
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.Genitourinary
Very common (10% or more): WBC/high power field (HPF) in urinalysis (up to 11.3%)
Common (1% to 10%): Albuminuria, red blood cells/HPF in urinalysis
Frequency not reported: Incontinence, menstrual irregularities, urinary retentionHematologic
Very common (10% or more): Low eosinophil count (up to 10.2%)
Common (1% to 10%): High eosinophil count, low monocyte count, low/high basophil count, low/high lymphocyte count, low/high neutrophil count, low/high WBC countMetabolic
Common (1% to 10%): High bilirubin, increased alkaline phosphatase, low/high creatinine
Frequency not reported: AnorexiaPsychiatric
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 this drug. The frequency and extent to which this drug 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 this drug. 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 this drug is associated with a greater risk of adverse behavioral effects than other benzodiazepines (including temazepam).
Common (1% to 10%): Anxiety, nervousness
Uncommon (0.1% to 1%): Confusional states, depression, euphoria
Rare (0.01% to 0.1%): Dreaming, insomnia, nightmares
Frequency not reported: Abnormal dreams, abuse, acute rage, addiction, aggressiveness, agitation, agitational state, bizarre behavior, changes in libido, delusions, depersonalization, derealization, disorientation, disorientation in time/place, excitation, hallucinations, inappropriate behavior, irritability, mania, other adverse behavioral effects, paranoia, restlessness, sleep disturbances, stimulationGastrointestinal
Common (1% to 10%): Nausea, vomiting
Rare (0.01% to 0.1%): Constipation, diarrhea, dry mouth
Frequency not reported: Burning tongue, glossitis, stomatitisOther
Common (1% to 10%): Tiredness
Uncommon (0.1% to 1%): Pain
Rare (0.01% to 0.1%): Tinnitus, weakness
Frequency not reported: Falling, paradoxical reactionsHepatic
Death from hepatic failure has been reported in a patient also receiving diuretic drugs.
Common (1% to 10%): High AST levels
Rare (0.01% to 0.1%): Death (from hepatic failure)
Frequency not reported: JaundiceDermatologic
Uncommon (0.1% to 1%): Pruritus, skin rash
Rare (0.01% to 0.1%): DermatitisCardiovascular
Uncommon (0.1% to 1%): Palpitations, tachycardia
Frequency not reported: Chest painRespiratory
Uncommon (0.1% to 1%): Hiccups
Rare (0.01% to 0.1%): Congestion
One study of patients with obstructive sleep apnea has suggested that this drug may increase the maximum apnea duration and lower the minimum oxygen saturation of apneic patients.Musculoskeletal
Uncommon (0.1% to 1%): Cramps
Frequency not reported: Increased muscle spasticityOcular
Uncommon (0.1% to 1%): Visual disturbancesHypersensitivity
Rare (0.01% to 0.1%): Allergy
Postmarketing reports: Anaphylactic shock, anaphylactoid reaction, allergic edema, angioneurotic edema, hypersensitivity reaction
August 31, 2020
May 12, 2020
November 24, 2020
December 2, 2020
November 15, 2020
December 2, 2020