Pronunciation: tem-AZE-uh-pam
Class: Benzodiazepine

Trade Names

Restoril
- Capsules 7.5 mg
- Capsules 15 mg
- Capsules 22.5 mg
- Capsules 30 mg

Apo-Temazepam (Canada)
CO Temazepam (Canada)
Gen-Temazepam (Canada)
PMS-Temazepam (Canada)
ratio-Temazepam (Canada)

Pharmacology

Potentiates action of GABA, an inhibitory neurotransmitter, resulting in increased neuronal inhibition and CNS depression, especially in limbic system and reticular formation.

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Pharmacokinetics

Absorption

Temazepam is completely absorbed. T _max is 2 to 3 h.

Distribution

Steady state is reached on the third day after a once-daily regimen; 96% bound to plasma proteins.

Metabolism

Temazepam undergoes minimal (about 8%) first-pass metabolism.

Elimination

Temazepam t _½ is approximately 10 h and 80% to 90% is excreted in urine.

Onset

Onset of action is 20 to 40 min.

Indications and Usage

Short-term management of insomnia (generally 7 to 10 days).

Contraindications

Hypersensitivity to benzodiazepines; pregnancy.

Dosage and Administration

Adults

PO 7.5 to 30 mg at bedtime; individualize therapy.

Elderly or Debilitated Patients

PO 7.5 mg until individual response is determined.

Storage/Stability

Store capsules at controlled room temperature (68° to 77°F).

Drug Interactions

Alcohol, other CNS depressants

Additive CNS depressant effects.

Digoxin

Serum digoxin concentrations may increase.

Theophylline

May antagonize sedative effects.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Drowsiness, headache (9%); dizziness, fatigue, lethargy, nervousness (5%); hangover (3%); anxiety, depression, euphoria (2%); confusion, nightmares, vertigo, weakness (1%); amnesia; ataxia; equilibrium loss; hallucinations; increased dreaming; paradoxical reactions (eg, excitement, agitation); tremor.

EENT

Blurred vision (1%); burning eyes; hyperhidrosis.

GI

Nausea (3%); abdominal discomfort, diarrhea, dry mouth (2%); anorexia; vomiting.

Miscellaneous

Blood dyscrasias; elevated AST, ALT, bilirubin; physical and psychological dependence; tolerance.

Precautions

Pregnancy

Category X .

Lactation

Undetermined. Similar drugs excreted in breast milk.

Children

Not for use in children younger than 18 yr of age.

Elderly

Increased adverse reactions; start with lowest dose.

Renal Function

Use with caution. Abnormal blood dyscrasias have occurred.

Hepatic Function

Use with caution. Abnormal LFT results and blood dyscrasias have occurred.

Anterograde amnesia

Has occurred with similar drugs. Alcohol may increase risk.

Dependence/Withdrawal

Prolonged use can lead to psychological or physical dependence. Withdrawal syndrome may occur; dose must be tapered gradually.

Depression/Suicide

Supervise depressed patients at risk during initial therapy. Prescribe the smallest quantity consistent with good patient management in order to reduce the risk of overdose.

Rebound sleep disorder

Characterized by recurrence of insomnia to levels worse than before treatment began, may occur during abrupt withdrawal.

Overdosage

Symptoms

Symptoms of decreased CNS function: somnolence, confusion, respiratory depression, decreased BP, seizures, coma, impaired coordination, slurred speech.

Patient Information

• Advise patient to read the patient information leaflet before starting therapy and with each refill.
• Review lifestyle changes that may improve sleep (eg, quiet and dark environment, avoidance of caffeine and nicotine, warm water bath, relaxation techniques).
• Advise patient that medication is usually started at a low dose and then gradually increased until maximum benefit is obtained.
• Advise patient to take prescribed dose 15 to 30 min before attempting to go to sleep.
• Caution patient not to take temazepam unless able to get a full night's sleep before being active again. Advise patient that taking temazepam with less than a full night's sleep may result in daytime amnesia or memory loss.
• Review safety precautions with regard to falls, especially for elderly and debilitated patients.
• Caution patient that medication may be habit forming and to take as prescribed and not to stop taking or change the dose unless advised by health care provider.
• Advise patient to take without regard to meals but to take with a snack if stomach upset occurs.
• Advise patient that sleep may be disturbed for 1 or 2 nights following discontinuation of temazepam therapy.
• Advise patient that if medication needs to be discontinued after long-term use it will be slowly withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Instruct patient to contact health care provider if symptoms do not appear to be getting better or worsen, or if bothersome adverse reactions (eg, daytime drowsiness, dizziness, incoordination, memory problems, changes in thinking or behavior) occur. Caution patient not to increase the dose on their own if symptoms do not appear to be improving.
• Advise patient that drug may cause drowsiness or impair judgment, thinking, or reflexes and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise women of childbearing potential to use effective contraception while using temazepam.

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