Brand and Other Names:Restoril
- Classes: Sedative/Hypnotics
Dosing & Uses
Dosage Forms & Strengths
capsule: Schedule IV
15-30 mg PO qHS
Debilitated patients: 7.5 mg PO qHS
- Discontinuation: Gradually taper after extended therapy; abrupt discontinuation should be avoided
Safety and efficacy not established
Preferred drug in elderly when benzodiazepine indicated because of lack of active metabolite
7.5 mg PO qHS; limit use to 10-14 days
Serious - Use Alternative
Significant - Monitor Closely
Sleep-related behavior (eg, sleep driving, sleep cooking, sleep eating)
Acute alcohol intoxication
Narrow-angle glaucoma (questionable)
Use caution in COPD, sleep apnea, renal/hepatic disease, impaired gag reflex, open-angle glaucoma (questionable), alcoholism, respiratory disease, depression, suicidal ideation
May impair ability to perform hazardous tasks
Caution with IV use in shock, coma, and depressed respiration and in patients who recently received other respiratory depressants
Anterograde amnesia may occur
Use in myasthenia gravis is allowed in limited circumstances
Use caution in severe respiratory depression and depressed neuroses, psychotic reactions
Paradoxical hyperactive aggressive behavior reported
May impair physical or mental abilities
May cause hyperactive or aggressive behavior
Pregnancy & Lactation
Pregnancy Category: X
Lactation: Avoid if breastfeeding
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)
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Depresses all levels of CNS (eg, limbic and reticular formation), possibly by increasing membrane permeability to chloride ions, which in turn increases the inhibitory activity of GABA on neuronal excitability.
Peak plasma time: 2-3 hr
Peak plasma concentration: 260-210 ng/mL
Protein bound: 96%
Vd: 1.4 L/kg
Metabolized by CYP3A4 (minor), glucuronic acid conjugation
Half-life elimination: 9.5-12.4 hr
Excretion: Urine (80-90%)
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