• Sleep-wake disorders

Sleep-wake disorders:

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.

Children:

Not established.

Contraindications:

Pregnancy (Cat.X).

Boxed Warning:

Risks from concomitant use with opioids.

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. Drug or alcohol abuse. Chronic pulmonary insufficiency. Renal or hepatic impairment. Write ℞ for smallest practical amount. Withdraw gradually. Elderly (higher risk of falls). Debilitated. Nursing mothers.

Pharmacologic Class:

Benzodiazepine.

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.

Adverse Reactions:

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

Generic Availability:

YES

How Supplied:

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

Pricing for RESTORIL

15mg capsule (Qty: 30)
Appx. price $11
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