Generic Name: Temazepam
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
Introduction
Benzodiazepine; sedative and hypnotic.a c
Uses for Restoril
Insomnia
Short-term (generally 7–10 days) management of insomnia.a c
Decreases sleep latency, reduces early morning awakening, and improves sleep maintenance in patients with chronic insomnia; similar effects in patients with transient insomnia.a
Restoril 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 Restoril
Contraindications
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 Restoril
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
|
|
Restoril 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
ActionsActions
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 03/2011. 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/$351.4 or 60/$701.11
Restoril 22.5MG Capsules (MALLINCKRODT): 30/$332.05 or 90/$965.92
Restoril 30MG Capsules (MALLINCKRODT): 30/$332.05 or 60/$652.05
Restoril 7.5MG Capsules (MALLINCKRODT): 30/$332.05 or 60/$652.05
Temazepam 15MG Capsules (MYLAN): 30/$12.99 or 90/$22.97
Temazepam 30MG Capsules (MYLAN): 30/$14.99 or 90/$25.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 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.
More Restoril resources
- Restoril Side Effects (in more detail)
- Restoril Dosage
- Restoril Use in Pregnancy & Breastfeeding
- Drug Images
- Restoril Drug Interactions
- Restoril Support Group
- 17 Reviews for Restoril - Add your own review/rating
- Restoril Prescribing Information (FDA)
- Restoril Consumer Overview
- Restoril Advanced Consumer (Micromedex) - Includes Dosage Information
- Restoril MedFacts Consumer Leaflet (Wolters Kluwer)
- Temazepam Prescribing Information (FDA)
- Temazepam Professional Patient Advice (Wolters Kluwer)
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