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RESTORIL
Sleep-wake disorders
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Drug Name:

RESTORIL CIV

Generic Name and Formulations:
Temazepam 7.5mg, 15mg, 22.5mg, 30mg; caps.

Company:
Mallinckrodt, Inc.

Therapeutic Use:

Indications for RESTORIL:

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

Adult:

Use lowest effective dose. Usual dose: 7.5mg–30mg at bedtime. Elderly or debilitated: initially 7.5mg. Max 1 month/℞.

Children:

<18yrs: not established.

Contraindications:

Pregnancy (Cat.X).

Warnings/Precautions:

Risks from concomitant use with opioids; see Interactions. Suicidal tendencies. Depression. Pulmonary, renal, or hepatic impairment. Drug or alcohol abuse. Reevaluate if used ≥2 weeks. Sleep disturbances after stopping drug. Avoid abrupt cessation after prolonged use. Nursing mothers.

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 or other CNS depressants.

Pharmacological Class:

Benzodiazepine.

Adverse Reactions:

Drowsiness, headache, fatigue, nervousness, lethargy, dizziness, hangover, confusion, weakness, paradoxical excitement, euphoria; sleep-driving and other complex behaviors (eg, preparing/eating food), anaphylaxis, angioedema.

Generic Availability:

YES

How Supplied:

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

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