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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


Special Alerts:

[Posted 08/31/2016]

AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice

ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication, available at: , for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.

FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication, available at: , for a Data Summary). Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.

FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.

BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures.

RECOMMENDATION: Health care professionalsshould limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.

Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

For more information visit the FDA website at: and .


Benzodiazepine; sedative and hypnotic.a c

Uses for Restoril

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


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


  • 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


Oral Administration

Administer at bedtime.a c


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.



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


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Pregnancy.a b

  • Known hypersensitivity to benzodiazepines.b



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


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


Category X.a


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




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


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



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



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




Conjugated in the liver to form inactive metabolites.a

Elimination Route

Excreted in urine as inactive metabolites.a b


About 8 hours.a b





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


  • 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

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • 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


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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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



Dosage Forms


Brand Names




7.5 mg*

Restoril ( C-IV)


15 mg*

Restoril ( C-IV)


Temazepam Capsules

Actavis, Mylan, Sandoz

22.5 mg

Restoril ( C-IV)


30 mg*

Restoril ( C-IV)


Temazepam Capsules

Actavis, Mylan, Sandoz

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Date published: May 01, 2004
Last reviewed: September 01, 2016
Date modified: September 02, 2016


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.