Temazepam

Temazepam
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Temazepam is a benzodiazepines that is FDA approved for the treatment of It is indicated for the short-term treatment of insomnia (generally 7 to 10 days).. Common adverse reactions include anorexia, ataxia, equilibrium loss, tremor, increased dreaming, dyspnea, palpitations, vomiting, backache, hyperhidrosis, burning eyes, amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%)..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• It is indicated for the short-term treatment of insomnia (generally 7 to 10 days).
• For patients with short-term insomnia, instructions in the prescription should indicate that Restoril™ (temazepam) should be used for short periods of time (7 to 10 days).
• The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
• While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Temazepam in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Temazepam in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Temazepam FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Temazepam in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Temazepam in pediatric patients.

Contraindications

• Benzodiazepines may cause fetal harm when administered to a pregnant woman. * An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies.
• Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.
• Reproduction studies in animals with temazepam were performed in rats and rabbits.
• In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality.
• Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher.
• In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship.
• Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls.
• At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls.
• Restoril is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Warnings

• Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder.
• Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.
• 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 may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior. Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class.
• Because some of the worrisome adverse effects of benzodiazepines, including Restoril, appear to be dose related, it is important to use the lowest possible effective dose. Elderly patients are especially at risk.
• Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol.
• Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported.
• 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 Restoril alone at therapeutic doses, the use of alcohol and other CNS depressants with Restoril appears to increase the risk of such behaviors, as does the use of Restoril at doses exceeding the maximum recommended dose.
• Due to the risk to the patient and the community, discontinuation of Restoril should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., 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. As with sleep-driving, patients usually do not remember these events.
• Amnesia and other neuro-psychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics.
• 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.
• Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines.

Severe Anaphylactic and Anaphylactoid Reactions

• Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Restoril.
• Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department.
• If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Restoril should not be rechallenged with the drug.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Temazepam Clinical Trials Experience in the drug label.

Postmarketing Experience

The following adverse events have been reported less frequently (0.5% to 0.9%):

Central Nervous System

Anorexia, ataxia, equilibrium loss, tremor, increased dreaming

Cardiovascular

Dyspnea, palpitations

Gastrointestinal

Vomiting

Musculoskeletal

Backache

Special Senses

Hyperhidrosis, burning eyes

Psychological

Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).

Drug Interactions

There is limited information regarding Temazepam Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Temazepam in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Temazepam in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Temazepam during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Temazepam with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Temazepam with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Temazepam with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Temazepam with respect to specific gender populations.

Race

There is no FDA guidance on the use of Temazepam with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Temazepam in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Temazepam in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Temazepam in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Temazepam in patients who are immunocompromised.

Administration and Monitoring

Administration

• While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

Monitoring

There is limited information regarding Temazepam Monitoring in the drug label.

IV Compatibility

Intravenous

Overdosage

• Manifestations of acute overdosage of Restoril can be expected to reflect the CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension.
• The oral LD50 of Restoril was 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits.

Treatment

• If the patient is conscious, vomiting should be induced mechanically or with emetics.
• Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and pulmonary complications.
• Maintenance of adequate pulmonary ventilation is essential. The use of pressor agents intravenously may be necessary to combat hypotension.
• Fluids should be administered intravenously to encourage diuresis. The value of dialysis has not been determined. If excitation occurs, barbiturates should not be used.
• It should be borne in mind that multiple agents may have been ingested. Flumazenil (Romazicon®)*, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected.
• Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access.
• Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose.
• Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment.
• The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.
• Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians.

DOSAGE AND ADMINISTRATION

• While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency.
• In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

Pharmacology

Mechanism of Action

Structure

File:Temazepam01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Temazepam in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Temazepam in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Temazepam in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Temazepam in the drug label.

How Supplied

Storage

There is limited information regarding Temazepam Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Temazepam in the drug label.

Precautions with Alcohol

• Alcohol-Temazepam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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