RESTORIL

Restoril Generic Name & Formulations

Legal Class

CIV

General Description

Temazepam 7.5mg, 15mg, 22.5mg, 30mg; caps.

Pharmacological Class

Benzodiazepine.

How Supplied

Caps 7.5mg—30, 100; 22.5mg—30; 15mg, 30mg—100

Manufacturer

Mallinckrodt, Inc.

Generic Availability

YES

Mechanism of Action

Temazepam works by enhancing the effects of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system.

Restoril Indications

Indications

Short-term (7–10 days) treatment of insomnia.

Restoril Dosage and Administration

Adult

Use lowest effective dose. Usual dose: 7.5mg–30mg at bedtime. Elderly or debilitated: initially 7.5mg.

Children

Not established.

Restoril Contraindications

Not Applicable

Restoril Boxed Warnings

Boxed Warning

Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

Restoril Warnings/Precautions

Warnings/Precautions

Increased risk of drug-related mortality from concomitant use with opioids. Risk of CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses before initiation. Reevaluate if insomnia fails to remit after 7–10 days of use. Depression. Suicidal tendencies. Abnormal thinking and behavioral changes. Chronic pulmonary insufficiency. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. Write ℞ for smallest practical amount. Renal or hepatic impairment. Elderly (higher risk of falls). Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

Restoril Pharmacokinetics

Distribution

96% plasma protein bound.

Metabolism

Conjugation.

Elimination

Renal (80–90%). Half-life: 3.5–18.4 hours.

Restoril Interactions

Interactions

Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Additive CNS depressant effects with alcohol, other CNS depressants.

Restoril Adverse Reactions

Adverse Reactions

Drowsiness, headache, fatigue, nervousness, lethargy, dizziness, nausea, hangover; CNS effects, complex behaviors (eg, sleep-driving), anaphylaxis, angioedema, withdrawal reactions.

Restoril Clinical Trials

See Literature

Restoril Note