temazepam (Rx)

Brand and Other Names:Restoril
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule: Schedule IV

  • 7.5mg
  • 15mg
  • 22.5mg
  • 30mg

Insomnia

15-30 mg PO qHS

Debilitated patients: 7.5 mg PO qHS

Discontinuation: Gradually taper after extended therapy; abrupt discontinuation should be avoided

Safety and efficacy not established

Insomnia

7.5 mg PO qHS; limit use to 10-14 days

Preferred drug in elderly when benzodiazepine indicated because of lack of active metabolite

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Interactions

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            Adverse Effects

            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

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            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

            • 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

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            Pregnancy & Lactation

            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 gain

            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.

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            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.

            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%)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Restoril oral
            -
            7.5 mg capsule
            Restoril oral
            -
            30 mg capsule
            Restoril oral
            -
            15 mg capsule
            Restoril oral
            -
            22.5 mg capsule
            temazepam oral
            -
            30 mg capsule
            temazepam oral
            -
            30 mg capsule
            temazepam oral
            -
            30 mg capsule
            temazepam oral
            -
            15 mg capsule
            temazepam oral
            -
            7.5 mg capsule
            temazepam oral
            -
            30 mg capsule
            temazepam oral
            -
            15 mg capsule
            temazepam oral
            -
            7.5 mg capsule
            temazepam oral
            -
            15 mg capsule
            temazepam oral
            -
            30 mg capsule
            temazepam oral
            -
            22.5 mg capsule
            temazepam oral
            -
            15 mg capsule
            temazepam oral
            -
            15 mg capsule
            temazepam oral
            -
            22.5 mg capsule
            temazepam oral
            -
            22.5 mg capsule
            temazepam oral
            -
            7.5 mg capsule
            temazepam oral
            -
            15 mg capsule
            temazepam oral
            -
            15 mg capsule
            temazepam oral
            -
            7.5 mg capsule
            temazepam oral
            -
            22.5 mg capsule
            temazepam oral
            -
            30 mg capsule
            temazepam oral
            -
            7.5 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            temazepam 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 using temazepam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually just before you get into bed. The dosage is based on your medical condition, age, and response to treatment.Although unlikely, this drug can rarely cause temporary short-term memory loss. To lessen the chance of this, do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss.When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.Tell your doctor if your condition lasts after 7 to 10 days, or if it gets worse.You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1 or 2 nights. If this effect continues, contact your doctor.

            SIDE EFFECTS: See also Warning section.Dizziness or difficulty with coordination may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness or falling, get up slowly when rising from a sitting or lying position.This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking temazepam.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking temazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, oxazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), mental/mood problems (such as depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of sleepwalking, a certain muscle disease (myasthenia gravis).Since this drug makes you drowsy, do not drive, use machinery, or do anything that needs alertness until you can do it safely. Alcohol or marijuana (cannabis) can make you more drowsy. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling.Temazepam must not be used during pregnancy. It may harm an unborn baby. If you are a woman of childbearing age, use a reliable form of birth control while taking this drug. If you are planning pregnancy, do not take this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: sodium oxybate.The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include slowed breathing or a deep sleep from which you cannot be awakened.

            NOTES: Do not share this medication with others. Sharing it is against the law.As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.

            MISSED DOSE: If you miss a dose, do not take it unless you have time to sleep for 7 to 8 hours afterward. (See also How to Use section.)

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised January 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.