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Temazepam

Pronunciation

Class: Benzodiazepines
VA Class: CN302
Chemical Name: 7-Chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one
Molecular Formula: C16H13ClN2O2
CAS Number: 846-50-4
Brands: Restoril

Introduction

Benzodiazepine; sedative and hypnotic.a c

Uses for Temazepam

Insomnia

Short-term (generally 7–10 days) management of insomnia.a c

Slideshow: Need To Catch Some Shut-Eye? Tips on Getting the Sleep You Need

Decreases sleep latency, reduces early morning awakening, and improves sleep maintenance in patients with chronic insomnia; similar effects in patients with transient insomnia.a

Temazepam Dosage and Administration

General

  • Use only when able to get 7–8 hours of sleep before being active again.a

  • Generally limit hypnotic therapy to 7–10 days.a

  • Avoid abrupt discontinuance; after extended therapy at doses >15 mg, taper dosage gradually.a

Administration

Oral Administration

Administer at bedtime.a c

Dosage

Adults

Insomnia
Oral

7.5–30 mg; 15 mg is the usual recommended dose.a c In patients with transient insomnia, 7.5 mg may be sufficient.a

Special Populations

Geriatric or Debilitated Patients

Possible increased sensitivity to benzodiazepines.a b Initially, 7.5 mg.a c

Cautions for Temazepam

Contraindications

  • Pregnancy.a b

  • Known hypersensitivity to benzodiazepines.b

Warnings/Precautions

Warnings

Adequate Patient Evaluation

Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.a

Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric and/or medical condition.a

Immediately evaluate any new behavioral sign or symptom.a

Adverse Psychiatric Events

Abnormal thinking and behavioral changes (e.g., aggressiveness, uncharacteristic extroversion, bizarre behavior, agitation, hallucinations, depersonalization, amnesia) may occur unpredictably in patients receiving benzodiazepines.a

Some adverse effects appear to be dose related; use the lowest effective dose.a

Complex Sleep-related Behaviors

Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug, with no memory of the event), making phone calls, or preparing and eating food while asleep.

Abuse Potential

Psychologic and physical dependence may occur following prolonged use.a

Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.a

Withdrawal Effects

Rapid dosage reduction or abrupt discontinuance may result in signs and symptoms of withdrawal (similar to barbiturates or alcohol).a c

Sensitivity Reactions

Potential risk of anaphylaxis and angioedema; may occur as early as with the first dose of drug.

General Precautions

Suicide

Use with caution in depressed patients; potential for suicidal tendencies.a Prescribe and dispense drug in the smallest feasible quantity.a b

CNS Effects

Performance of activities requiring mental alertness and physical coordination may be impaired.a b In clinical studies, risk of residual daytime sedation and impaired psychomotor and mental performance appeared to be minimal.a

Concurrent use of other CNS depressants may potentiate CNS depression.a b (See Specific Drugs under Interactions.)

Respiratory Effects

Use with caution in patients with compromised respiratory function.a

Specific Populations

Pregnancy

Category X.a

Lactation

Benzodiazaepines generally are distributed into milk; not known whether temazepam is distributed into milk.a

Caution advised if used in nursing women.a

Pediatric Use

Safety and efficacy not established in children <18 years of age.a c

Geriatric Use

Potential increased sensitivity (increased risk of oversedation, dizziness, confusion, and/or ataxia); use low initial dose and monitor closely.a (See Geriatric or Debilitated Patients under Dosage and Administration.)

Common Adverse Effects

Drowsiness, fatigue, lethargy, dizziness, hangover, anxiety, diarrhea, euphoria, weakness, confusion, vertigo.a

Interactions for Temazepam

Specific Drugs

Drug

Interaction

Comments

CNS depressants (e.g., sedatives, psychotropic drugs, anticonvulsants, antihistamines, alcohol)

Additive depressant effecta b

Do not use with alcohol; consider dosage reduction if temazepam is administered concomitantly with other CNS depressantsa b

Diphenhydramine

Possible synergistic effecta b

Concomitant use in a pregnant woman at term was associated with stillbirth 8 hours after administration; causal relationship not establisheda b

Temazepam Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration,a b with peak plasma concentrations achieved in about 1.2–1.6 hours.a

Distribution

Extent

Benzodiazepines are widely distributed into body tissues and cross the blood-brain barrier.b

Benzodiazepines generally cross the placenta and are distributed into milk;b not known whether temazepam distributes into milk.a

Plasma Protein Binding

96%.a

Elimination

Metabolism

Conjugated in the liver to form inactive metabolites.a

Elimination Route

Excreted in urine as inactive metabolites.a b

Half-life

About 8 hours.a b

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 20–25°C.a

Actions

  • Effects appear to be mediated through the inhibitory neurotransmitter GABA; the sites and mechanisms of action within the CNS appear to involve a macromolecular complex (GABAA-receptor-chloride ionophore complex) that includes GABAA receptors, high-affinity benzodiazepine receptors, and chloride channels.

Advice to Patients

  • Provide patient with a copy of manufacturer’s patient information.a

  • Importance of taking only as prescribed; do not increase dosage or duration of therapy unless otherwise instructed by a clinician.a

  • Importance of informing clinicians of any behavioral or mental changes, memory impairment, tolerance, or dependence/withdrawal symptoms.a

  • Importance of taking only when able to get a full night’s sleep (i.e., 7–8 hours) before being active again.a

  • Potential for drug to impair mental alertness or physical coordination; use caution when operating machinery or performing hazardous tasks until effects on individual are known.a

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescriptions and OTC drugs, and of concomitant illnesses, particularly depression.a

  • Importance of not consuming alcoholic beverages.a

  • Risk of rebound insomnia for 1 or 2 nights after discontinuance.a

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b

  • Importance of informing patients of other important precautionary information. (See Cautions.)a

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule IV (C-IV) drug.a

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Temazepam

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

7.5 mg*

Restoril (C-IV)

Mallinckrodt

15 mg*

Restoril (C-IV)

Mallinckrodt

Temazepam Capsules

Actavis, Mylan, Sandoz

22.5 mg

Restoril (C-IV)

Mallinckrodt

30 mg*

Restoril (C-IV)

Mallinckrodt

Temazepam Capsules

Actavis, Mylan, Sandoz

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Restoril 15MG Capsules (MALLINCKRODT): 30/$368.93 or 60/$733.78

Restoril 22.5MG Capsules (MALLINCKRODT): 30/$348.75 or 90/$1,014.01

Restoril 30MG Capsules (MALLINCKRODT): 30/$348.76 or 60/$685.44

Restoril 7.5MG Capsules (MALLINCKRODT): 30/$348.76 or 60/$584.60

Temazepam 15MG Capsules (MYLAN): 30/$12.99 or 90/$22.97

Temazepam 22.5MG Capsules (MALLINCKRODT PHARM): 30/$199.98 or 90/$579.99

Temazepam 30MG Capsules (MYLAN): 30/$14.99 or 90/$25.97

Temazepam 7.5MG Capsules (MALLINCKRODT PHARM): 30/$155.99 or 90/$449.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Mallinckrodt. Restoril (temazepam) capsules prescribing information. St. Louis, MO. 2006 May 24.

b. AHFS drug information 2003. McEvoy GK, ed. Benzodiazepine general statement. Bethesda, MD: American Society of Hospital Pharmacists; 2003:2353-60.

c. AHFS drug information 2003. McEvoy GK, ed. Temazepam. Bethesda, MD: American Society of Hospital Pharmacists; 2003:2380.

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