Temazepam

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Substrate of
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Finland: Tenox-Orion; France: Normison; Germany: Norkotral Tema, Planum, Pronervon T, Remestan, Temazep; Greece: Normison; Hungary: Signopam; Ireland: Insomniger, Nortem, Tenox-Orion; Italy: Normison; Luxembourg: Normison; Malta: Temazepam; Netherlands: Normison, Temazepam; Poland: Signopam; Portugal: Normison; UK: Temazepam.

North America

Canada: Restoril, Temazepam; USA: Restoril, Temazepam.

Drug combinations

Chemistry

Temazepam: C~16~H~13~ClN~2~O~2~. Mw: 300.74. (1) 2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-; (2) 7-Chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. CAS-846-50-4 (1969).

Pharmacologic Category

Anxiolytics, Sedatives, and Hypnotics; Benzodiazepines. (ATC-Code: N05CD07).

Mechanism of action

A short half-life benzodiazepine. Binds to stereospecific benzodiazepine receptors on postsynaptic GABA neuron at several sites within CNS, including limbic system. Enhances 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.

Therapeutic use

Short-term treatment of insomnia.

Pregnancy and lactiation implications

Contraindicated in pregnancy and nursing.

Unlabeled use

Treatment of anxiety. Adjunct in treatment of depression. Management of panic attacks.

Contraindications

Hypersensitivity to temazepam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist). Narrow-angle glaucoma (benzodiazepines contraindicated). Pregnancy.

Warnings and precautions

Benzodiazepines associated with anterograde amnesia. May cause CNS depression. Postmarketing studies indicated that use of hypnotic/sedative agents for sleep associated with hypersensitivity reactions including anaphylaxis as well as angioedema. Paradoxical reactions, including hyperactive or aggressive behavior, reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients. Increased risk for hazardous sleep-related activities such as sleep-driving; cooking and eating food, and making phone calls while asleep also noted. Use caution in depression, particularly if suicidal risk may be present, and in history of drug abuse or acute alcoholism. Potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use. Use with caution in hepatic and renal impairment, in impaired gag reflux, in respiratory disease, and in patients receiving other CNS depressants or psychoactive medication. Effects with other sedative drugs or ethanol may be potentiated. Use with caution in debilitated patients, in the elderly and in patients who are at risk of falls; (benzodiazepines associated with falls and traumatic injury). Does not have analgesic, antidepressant, or antipsychotic properties. Failure of sleep disturbance to resolve after 7-10 days may indicate psychiatric or medical illness. Rebound or withdrawal symptoms may occur following abrupt discontinuation or large decreases in dose. Flumazenil may cause withdrawal in patients receiving long-term benzodiazepine therapy.

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