propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.protriptylineMonitor Closely (1)temazepam and protriptyline both increase sedation. Use Caution/Monitor.quazepamMonitor Closely (1)quazepam and temazepam both increase sedation. Use Caution/Monitor.quetiapineMonitor Closely (1)temazepam and quetiapine both increase sedation. Use Caution/Monitor.ramelteonMonitor Closely (1)temazepam and ramelteon both increase sedation. Use Caution/Monitor.remimazolamMonitor Closely (1)remimazolam, temazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.rifabutinMinor (1)rifabutin decreases levels of temazepam by increasing metabolism. Minor/Significance Unknown.risperidoneMonitor Closely (1)temazepam and risperidone both increase sedation. Use Caution/Monitor.ropeginterferon alfa 2bSerious - Use Alternative (1)ropeginterferon alfa 2b and temazepam both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.sageMinor (1)temazepam and sage both increase sedation. Minor/Significance Unknown.salmeterolMonitor Closely (1)temazepam increases and salmeterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.scullcapMonitor Closely (1)temazepam and scullcap both increase sedation. Use Caution/Monitor.secobarbitalMonitor Closely (1)secobarbital and temazepam both increase sedation. Use Caution/Monitor.selinexorSerious - Use Alternative (1)selinexor, temazepam. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.sevofluraneMonitor Closely (1)sevoflurane and temazepam both increase sedation. Use Caution/Monitor.shepherd's purseMonitor Closely (1)temazepam and shepherd's purse both increase sedation. Use Caution/Monitor.sodium oxybateContraindicated (1)temazepam, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.stiripentolMonitor Closely (1)stiripentol, temazepam. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.sufentanilMonitor Closely (1)temazepam and sufentanil both increase sedation. Use Caution/Monitor.sufentanil SLSerious - Use Alternative (1)sufentanil SL, temazepam. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.tapentadolMonitor Closely (1)temazepam and tapentadol both increase sedation. Use Caution/Monitor.terbutalineMonitor Closely (1)temazepam increases and terbutaline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.thioridazineMonitor Closely (1)temazepam and thioridazine both increase sedation. Use Caution/Monitor.thiothixeneMonitor Closely (1)temazepam and thiothixene both increase sedation. Use Caution/Monitor.topiramateMonitor Closely (1)temazepam and topiramate both increase sedation. Modify Therapy/Monitor Closely.tramadolMonitor Closely (1)temazepam and tramadol both increase sedation. Use Caution/Monitor.trazodoneMonitor Closely (1)temazepam and trazodone both increase sedation. Use Caution/Monitor.triazolamMonitor Closely (1)temazepam and triazolam both increase sedation. Use Caution/Monitor.triclofosMonitor Closely (1)temazepam and triclofos both increase sedation. Use Caution/Monitor.trifluoperazineMonitor Closely (1)temazepam and trifluoperazine both increase sedation. Use Caution/Monitor.trimipramineMonitor Closely (1)temazepam and trimipramine both increase sedation. Use Caution/Monitor.triprolidineMonitor Closely (1)triprolidine and temazepam both increase sedation. Use Caution/Monitor.valerianSerious - Use Alternative (1)valerian and temazepam both increase sedation. Avoid or Use Alternate Drug.vinpocetineMinor (1)temazepam increases effects of vinpocetine by unspecified interaction mechanism. Minor/Significance Unknown. Desirable interaction enhanced memory improvement (based on preliminary trial).xylometazolineMonitor Closely (1)temazepam increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.yohimbineMonitor Closely (1)temazepam increases and yohimbine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.ziconotideMonitor Closely (1)temazepam and ziconotide both increase sedation. Use Caution/Monitor.ziprasidoneMonitor Closely (1)temazepam and ziprasidone both increase sedation. Use Caution/Monitor.zolpidemMinor (1)zolpidem, temazepam. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Additive CNS depression.zotepineMonitor Closely (1)temazepam and zotepine both increase sedation. Use Caution/Monitor. 1-10% Drowsiness (9.1%) Dizziness (4.5%) Lethargy (4.5%) Hangover (2.5%) Diarrhea (1.7%) Euphoria (1.5%) Weakness (1.4%) Confusion (1.3%) Vertigo (1.2%) < 1% Amnesia Angioedema Blood dyscrasias Sleep-related behavior (eg, sleep driving, sleep cooking, sleep eating) Ataxia 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 On 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 Narrow-angle glaucoma (questionable) Caution Use caution in COPD, sleep apnea, renal/hepatic disease, impaired gag reflex, open-angle glaucoma (questionable), alcoholism, respiratory disease, depression, suicidal ideation May impair ability to perform hazardous tasks Caution with IV use in shock, coma, and depressed respiration and in patients who recently received other respiratory depressants Anterograde amnesia may occur Use caution in patients with history of drug abuse or acute alcoholism; tolerance, psychological and physical dependence may occur with prolonged use Use in myasthenia gravis is allowed in limited circumstances Use caution in severe respiratory depression and depressed neuroses, psychotic reactions Paradoxical hyperactive aggressive behavior reported Therapy can cause drowsiness and a decreased level of consciousness; patients, particularly the elderly, are at higher risk of falls May cause hyperactive or aggressive behavior 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 using treated more frequently than recommended, to reduce risk of withdrawal reactions, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose) 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 Pregnancy There is pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for psychiatric Medications at 1-866-961-2388 or visiting online athttps://womensmentalhealth.org/pregnancyregistry/ Neonates born to mothers using benzodiazepines late in pregnancy reported to experience symptoms of sedation and/or neonatal withdrawal; available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates; monitor neonates exposed during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems; monitor neonates exposed to therapy during pregnancy for signs of withdrawal; manage these neonates accordingly Lactation This drug is present in breast milk; there are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk The effects of this drug on milk production are unknown; 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 breastfed infant from therapy or from underlying maternal condition infants exposed to therapy through breast milk should be monitored for sedation, poor feeding and poor weight gainPregnancy 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. 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. Absorption Peak plasma time: 2-3 hr Peak plasma concentration: 260-210 ng/mL Distribution Protein bound: 96% Vd: 1.4 L/kg Metabolism Metabolized by CYP3A4 (minor), glucuronic acid conjugation Metabolites: Inactive Elimination Half-life elimination: 9.5-12.4 hr Excretion: Urine (80-90%) BRAND FORM. UNIT PRICE PILL IMAGE temazepam oral- 30 mg capsuletemazepam oral- 7.5 mg capsuletemazepam oral- 30 mg capsuletemazepam oral- 7.5 mg capsuletemazepam oral- 30 mg capsuletemazepam oral- 15 mg capsuletemazepam oral- 15 mg capsuletemazepam oral- 15 mg capsuletemazepam oral- 30 mg capsuletemazepam oral- 22.5 mg capsuletemazepam oral- 15 mg capsuletemazepam oral- 30 mg capsuletemazepam oral- 15 mg capsuletemazepam oral- 7.5 mg capsuletemazepam oral- 30 mg capsuletemazepam oral- 22.5 mg capsuletemazepam oral- 7.5 mg capsuletemazepam oral- 15 mg capsuletemazepam oral- 22.5 mg capsuletemazepam oral- 15 mg capsuletemazepam oral- 7.5 mg capsuletemazepam oral- 22.5 mg capsuleRestoril oral- 30 mg capsuleRestoril oral- 7.5 mg capsuleRestoril oral- 22.5 mg capsuleRestoril oral- 15 mg capsuleCopyright © 2010 First DataBank, Inc.Print Patient Educationtemazepam oral TEMAZEPAM - ORAL (teh-MAZ-eh-pam) COMMON BRAND NAME(S): Restoril WARNING: Temazepam has a risk for abuse and addiction, which can lead to overdose and death. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of temazepam that works, and take it for the shortest possible time. Be sure you know how to take temazepam and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months. USES: This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Temazepam belongs to a class of drugs called benzodiazepines. It acts on your brain to produce a calming effect.Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment. HOW TO USE: See also Warning section.Read the Medication Guide provided by your pharmacist before you start