Temazepam, Restoril®

Brand name

  • Restoril®

Drug Class

  • Benzodiazepines
  • Sedative-Hypnotics
  • Muscle relaxants

Preparations

  • Capsule, oral: 7.5 mg, 15 mg, 22.5 mg, 30 mg
  • Restoril™: 7.5 mg, 15 mg, 22.5 mg, 30 mg

Indications

  • Short-term treatment of insomnia

Pharmacology

  • Half-life elimination: 9.5-12.4 hours
  • Time to peak, serum: 2-3 hours

Metabolism

  • Metabolism: Hepatic

Dosing

  • Insomnia: 7.5 mg to 30 mg at bedtime
  • Anxiety: open-label use

Drug Interactions

  • CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants.
  • Alcohol (Ethyl): may enhance the CNS depressant effect of Alcohol (Ethyl).
  • CloZAPine: Benzodiazepines may enhance the adverse/toxic effect of CloZAPine.
    • Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. 
  • Fospenytoin: Benzodiazepines may increase the serum concentration of Fosphenytoin.
  • Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine.
  • OLANZapine: May enhance the adverse effect of Benzodiazepines.
    • Management: Avoid concomitant use of parenteral benzodiazepines and IM olanzapine due to risks of additive adverse events (e.g., cardiorespiratory depression).
  • Phenytoin: Benzodiazepines may increase the serum concentration of Phenytoin
  • SSRIs: CNS Depressants may enhance the adverse effects of SSRIs
  • Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates

Adverse Effects

Reported 1% to 10%:

  • Central nervous system: Anxiety, confusion, dizziness, drowsiness, euphoria, fatigue, hangover, headache, lethargy, vertigo
  • Dermatologic: Rash
  • Endocrine & metabolic: Libido decreased
  • Gastrointestinal: Diarrhea
  • Neuromuscular & skeletal: Dysarthria, weakness
  • Ocular: Blurred vision
  • Miscellaneous: Diaphoresis

Contraindications

  • Hypersensitivity to temazepam or any component of the formulation
  • Narrow-angle glaucoma
  • Pregnancy

Pregnancy and Breastfeeding

  • Use with caution during pregnancy and breastfeeding

Precautions

Warning

  • Anterograde amnesia
  • CNS depression: patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving)
  • Paradoxical reactions: Paradoxical reactions, including hyperactive or aggressive behavior, have been 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

Section

This document is prepared by the “Mental Health for All” team. This document is provided for information purposes only and does not necessarily represent endorsement by or an official position of the Essentials of Medicine. Advice on the treatment or care of an individual patient should be obtained through consultation with a physician who has examined that patient or is familiar with that patient’s medical history.

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