Yes

Benzodiazepine

Short-term treatment of insomnia Unlabeled use: Treatment of anxiety; adjunct in the treatment of depression; management of panic attacks

C-IV

X

Hypersensitivity to this drug or any component of its formulation (cross-sensitivity with other benzodiazepines may exist); narrow-angle glaucoma (not in product labeling, however, benzodiazepines are contraindicated); pregnancy

Should be used only after evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7-10 days may indicate psychiatric or medical illness. A worsening of insomnia or the emergence of new abnormalities of thought or behavior may represent unrecognized psychiatric or medical illness and requires immediate and careful evaluation.

Causes CNS depression (dose-related) resulting in sedation, dizziness, confusion, or ataxia which may impair physical and mental capabilities. Patients must be cautioned about performing tasks which require mental alertness (ie, operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents. Effects with other sedative drugs or ethanol may be potentiated. Benzodiazepines have been associated with falls and traumatic injury and should be used with extreme caution in patients who are at risk of these events (especially the elderly).

Use caution in patients with depression, particularly if suicidal risk may be present. Use with caution in patients with a history of drug dependence. Benzodiazepines have been associated with dependence and acute withdrawal symptoms on discontinuation or reduction in dose. Acute withdrawal, including seizures, may be precipitated after administration of flumazenil to patients receiving long-term benzodiazepine therapy.

Benzodiazepines have been associated with anterograde amnesia. Paradoxical reactions, including hyperactive or aggressive behavior, have been reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients. Does not have analgesic, antidepressant, or antipsychotic properties.

1% to 10%:

Central nervous system: Confusion, dizziness, drowsiness, fatigue, anxiety, headache, lethargy, hangover, euphoria, vertigo

Dermatologic: Rash

Endocrine & metabolic: Decreased libido

Gastrointestinal: Diarrhea

Neuromuscular & skeletal: Dysarthria, weakness

Otic: Blurred vision

Miscellaneous: Diaphoresis

<1%: Palpitations, anorexia, ataxia, tremor, increased dreaming, amnesia, paradoxical reactions, menstrual irregularities, vomiting, blood, reflex slowing, back pain, drug dependence

Symptoms of overdose include somnolence, confusion, coma, hypoactive reflexes, dyspnea, hypotension, slurred speech, impaired coordination

Treatment for benzodiazepine overdose is supportive. Rarely is mechanical ventilation required. Flumazenil has been shown to selectively block the binding of benzodiazepines to CNS receptors, resulting in a reversal of benzodiazepine-induced CNS depression.

CYP3A3/4 enzyme substrate

Oral contraceptives may increase the clearance of temazepam

Temazepam may decrease the antiparkinsonian efficacy of levodopa

Theophylline and other CNS stimulants may antagonize the sedative effects of temazepam

Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the central nervous system, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization.

Protein binding: 96%

Metabolism: In the liver

Half-life: 9.5-12.4 hours

Time to peak serum concentration: Within 2-3 hours

Elimination: 80% to 90% excreted in urine as inactive metabolites

Adults: Oral: 15-30 mg at bedtime; 15 mg in elderly or debilitated patients

Alcohol: Additive CNS effect, avoid use

Respiratory and cardiovascular status

Therapeutic: 26 ng/mL after 24 hours

No information available to require special precautions

>10% of patients will exhibit significant dry mouth; normal salivary flow returns with cessation of drug therapy

Use exactly as directed (do not increase dose or frequency or discontinue without consulting prescriber); may cause physical and/or psychological dependence. May take with food to decrease GI upset. While using this medication, do not use alcohol or other prescription or OTC medications (especially, pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, dizziness, lightheadedness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or dry mouth or gastrointestinal discomfort (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report CNS changes (confusion, depression, increased sedation, excitation, headache, abnormal thinking, insomnia, or nightmares, memory impairment, impaired coordination); muscle pain or weakness; difficulty breathing; persistent dizziness, chest pain, or palpitations; alterations in normal gait; vision changes; or ineffectiveness of medication. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. Consult prescriber for instruction on appropriate barrier contraceptive measures. This drug may cause severe fetal defects. Breast-feeding is not recommended.

Provide safety measures (ie, side rails, night light, and call button); remove smoking materials from area; supervise ambulation

Capsule: 7.5 mg, 15 mg, 30 mg

Divoll M, Greenblatt DJ, Harmatz JS, et al, "Effect of Age and Gender on Disposition of Temazepam," J Pharm Sci, 1981, 70(10):1104-7.

Grahame-Smith DG, "Misuse of Temazepam," Br Med J (Clin Res Ed), 1991, 302(6786):1210.

Ho PC, Triggs EJ, Heazlewood V, et al, "Determination of Nitrazepam and Temazepam in Plasma by High Performance Liquid Chromatography," Ther Drug Monit, 1983, 5(3):303-7.

Klotz U and Kanto J, "Pharmacokinetics and Clinical Use of Flumazenil (Ro 15-1788)," Clin Pharmacokinet, 1988, 14(1):1-12.

Scharf MB, Berkowitz DV, and Brannen DE, "Effectiveness of Low-Dose Temazepam on Sleep Patterns in Geriatric Insomniac Subjects," Consult Pharm, 1993, 8(12):1367-73.