Dosing & Uses
Dosage Forms & Strengths
tablet: Schedule IV
- 0.125mg
- 0.25mg
Insomnia
0.125-0.25 mg PO qHS
Maximum dose: 0.5 mg PO qHS
Dosage Modifications
Hepatic impairment: Administer a lower dose; avoid use in cirrhosis
Safety and efficacy not established
Initiate a lower dose of 0.125 mg at bedtime; not to exceed 0.25 mg/day
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Drowsiness (14%)
1-10%
Headache (5-10%)
Dizziness (5-10%)
Nervousness (5-10%)
Ataxia (4-5%)
Lightheadedness (4-5%)
N/V (4-5%)
<1%
Anterogade amnesia
Paradoxical reactions
Travelers amnesia-especially if combined with EtOH
Confusion
Cramps
Fatigue
Memory impairment
Depression
Visual disturbance
Xerostomia
Anterograde amnesia
Dreaming/nightmares
Confusion
Warnings
Black Box Warnings
Risks from concomitant use with opioids
- Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death
- Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
- Limit dosages and durations to the minimum required
- Follow patients for signs and symptoms of respiratory depression and sedation
- Inform patients and caregivers that potentially fatal additive effects may occur if drug is used with opioids and that such drugs should not be used concomitantly unless supervised by a health care provider
- Prescribers should advise caregivers that they expect to be informed immediately if a patient develops any new findings which are not typical of the patient’s characteristic seizure episode
Addiction, abuse, and misuse
- In September 2020, FDA addressed serious risks of benzodiazepine addiction, abuse, and misuse, which can lead to overdose and death
- Physical dependence can occur when taken steadily for several days to weeks, even as prescribed
- Stopping abruptly or reducing dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening
- Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes; before prescribing and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction
- Assess each patient’s risk prior to prescribing and monitor regularly for the development of these conditions
- Risks of dependence and withdrawal increase with longer treatment duration and higher daily dose; although injection is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction may precipitate acute withdrawal reactions, including seizures, which can be life-threatening; use gradual taper when discontinuing therapy to reduce withdrawal reactions risk
Contraindications
Documented hypersensitivity
Acute alcohol intoxication
Myasthenia gravis (allowable in limited circumstances)
Narrow angle glaucoma (questionable)
Severe respiratory depression
Depressed neuroses, psychotic reactions
IV use in shock, coma, depressed respiration, patients who recently received other respiratory depressants
Medications that significantly impair oxidative metabolism mediated by cytochrome P450 3A (CYP 3A) including ketoconazole, itraconazole, nefazodone, and several HIV protease inhibitors
Caution
Use caution in COPD, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), impaired gag reflex, depression, suicide ideation
Benzodiazepines may worsen depression; take appropriate precautions (e.g., limiting total prescription size and increased monitoring for suicidal ideation) in patients with depression
Anterograde amnesia may occur
Hypersensitivity reactions reported
Sleep related activities (sleep driving, sleep-cooking, sleep-eating etc) may occur
Hyperactive aggressive behavior may occur
May impair ability to perform hazardous tasks
Failure of insomnia to remit after 7 - 10 days of treatment may indicate presence of primary psychiatric and/or medical illness that should be evaluated
Increase in daytime anxiety may occur; consider therapy discontinuation if this occurs
Use caution and consider appropriate dose reduction when used concomitantly with weak or moderate CYP450 3A inhibitors
Therapy can cause drowsiness and a decreased level of consciousness; patients, particularly the elderly, are at higher risk of falls
Use of Halcion during later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in neonates; observe newborns for signs of sedation and neonatal withdrawal syndrome and manage accordingly
Benzodiazepines expose users to risks of abuse, misuse, and addiction, which can lead to overdose or death; abuse and misuse of benzodiazepines often (but not always) involve use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death
Use of drug, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency
Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate
For patients treated more frequently than recommended, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose), to reduce risk of withdrawal reactions
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
In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months
Withdrawal effects
- Withdrawal phenomena results in increased wakefulness during last third of the night, and appearance of increased signs of daytime anxiety or nervousness
- Withdrawal effects can occur after discontinuing these drugs following use for only a week or two, but may be more common and more severe after longer periods of continuous use
- A phenomena known as ‘rebound insomnia’ may occur after stopping therapy, on the first few nights after drug is stopped, insomnia is actually worse than before the sleeping pill was given
- Other withdrawal phenomena following abrupt stopping of benzodiazepine sleeping pills range from mild unpleasant feelings to a major withdrawal syndrome which may include abdominal and muscle cramps, vomiting, sweating, tremor, and convulsions
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Other Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/
Infants born to mothers using benzodiazepines during later stages of pregnancy reported to experience symptoms of sedation and neonatal withdrawal
At this time, there is no clear evidence that triazolam exposure in early pregnancy can cause major birth defects
Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates; monitor neonates exposed to therapy during pregnancy and labor for signs of sedation, respiratory depression, withdrawal, and feeding problems and manage accordingly
Animal data
- Oral administration to male and female rats before mating, and continuing during gestation and lactation did not result in embryotoxicity at doses up to approximately 100 times the MRHD based on mg/m2 body surface area, but did cause an increase in number of stillbirths and postnatal pup mortalities at doses greater than or equal to approximately 40 times the MRHD based mg/m2 body surface area
Lactation
There are no data on presence of drug in human milk or effects on milk production; there are reports of central nervous system depression (sedation, respiratory depression), withdrawal symptoms, and feeding problems in infants who are breastfed by mothers taking benzodiazepines
The drug and its metabolites are present in the milk of lactating rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from drug or from underlying maternal condition
Infants exposed to drug through breast milk should be monitored for sedation, respiratory depression, withdrawal symptoms, and feeding problems; a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 28 hours (approximately 5 elimination half-lives) after therapy administration in order to minimize drug exposure to a breast fed infant
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Depresses all levels of CNS (eg, limbic and reticular formation), possibly by increasing membrane permeability to chloride ions, which in turn increases the inhibitory activity of GABA on neuronal excitability.
Pharmacokinetics
Half-Life: 1.5-5.5 hr
Peak plasma time: 0.5-2 hr
Onset of action: 15-30 min
Vd: 0.8-1.8 L/kg
Protein binding: 89%
Duration: 6-7 hr
Peak plasma concentration: 1-6 ng/mL
Metabolism: CYP3A4, glucuronic acid conjugation
Metabolites: Inactive metabolites
Excretion: Urine
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Formulary
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