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Temazepam

Brand Name: Restoril

Generic Name: Temazepam

Drug Class: Sedative/Hypnotics

What Is Temazepam and How Does It Work?

Temazepam is indicated for the short-term treatment of insomnia (generally 7 - 10 days).

For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7-10 days).

The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

Temazepam is available under the following different brand names: Restoril.

Dosage of Temazepam:

Dosage Forms and Strengths

Capsule: Schedule IV

  • 7.5 mg
  • 15 mg
  • 22.5 mg
  • 30 mg

Dosing Consideraations – Should be Given as Follows:

Insomnia

  • Adult: 15-30 mg orally at bedtime
  • Debilitated patients: 7.5 mg orally at bedtime
  • Geriatric: 7.5 mg orally at bedtime; limit use to 10-14 days
  • Preferred drug in elderly when benzodiazepine indicated because of lack of active metabolite
  • Discontinuation: Gradually taper after extended therapy; abrupt discontinuation should be avoided
  • Pediatric: Safety and efficacy not established

What Are Side Effects Associated with Using Temazepam?

Common Side effects of Temazepam include:

Less common side effects of temazepam include:

  • Amnesia
  • Blood dyscrasias
  • Problems with coordination
  • Skin swelling
  • Sleep-related behavior (e.g., sleep driving, sleep cooking, sleep eating)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

 

What Other Drugs Interact with Temazepam?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of temazepam include:

Serious Interactions of temazepam include:

  • fentanyl
  • fentanyl intranasal
  • fentanyl iontophoretic transdermal system
  • fentanyl transdermal
  • fentanyl transmucosal
  • hydrocodone
  • valerian

Temazepam has moderate interactions with at least 182 different drugs.

Mild Interactions of temazepam include:

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

 

What Are Warnings and Precautions for Temazepam?

Warnings

  • This medication contains temazepam
  • Do not take Restoril if you are allergic to temazepam or any ingredients contained in this drug
  • In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

Effects of Drug Abuse

  • No information available

Short-Term Effects

  • See "What Are Side Effects Associated with Using Temazepam?"

Long-Term Effects

  • See "What Are Side Effects Associated with Using Temazepam?"

Cautions

Pregnancy and Lactation

  • Do not use temazepam in pregnancy
  • The risks involved outweigh potential benefits. Safer alternatives exist.
  • Minor tranquilizers should be avoided in 1st trimester of pregnancy due to increased risk of congenital malformations
  • Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence)
  • Prenatal benzodiazepine exposure slightly increased oral cleft risk (limited or inconsistent evidence)
  • Avoid temazepam if breastfeeding