Use with caution in elderly or debilitated patients, patients with hepatic disease (including alcoholics), or renal impairment. Use with caution in patients with respiratory disease, or impaired gag reflex. Avoid use inpatients with sleep apnea.

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 (eg, 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 (may occur after as little as 10 days). 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

Ocular: Blurred vision

Miscellaneous: Diaphoresis

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

CNS depressants: Sedative effects and/or respiratory depression may be additive with CNS depressants; includes ethanol, barbiturates, narcotic analgesics, and other sedative agents; monitor for increased effect

Theophylline: May partially antagonize some of the effects of benzodiazepines; monitor for decreased response; may require higher doses for sedation

Ethanol: Avoid ethanol (may increase CNS depression).

Food: Serum levels may be increased by grapefruit juice.

Herb/Nutraceutical: St John's wort may decrease temazepam levels. Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).

Distribution: Vd: 1.4 L/kg

Protein binding: 96%

Metabolism: Hepatic

Half-life elimination: 9.5-12.4 hours

Time to peak, serum: 2-3 hours

Excretion: Urine (80% to 90% as inactive metabolites)

Adults: 15-30 mg at bedtime

Elderly or debilitated patients: 15 mg

Restoril®: 7.5 mg, 15 mg, 30 mg

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