Dosing and uses of Restoril (temazepam)
Adult dosage forms and strengths
capsule: Schedule IV
- 7.5mg
- 15mg
- 22.5mg
- 30mg
Insomnia
15-30 mg PO qHs
Debilitated patients: 7.5 mg PO qHs
Dosing considerations
- Discontinuation: Gradually taper after extended therapy; abrupt discontinuation should be avoided
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
Preferred drug in elderly when benzodiazepine indicated because of lack of active metabolite
Insomnia
7.5 mg PO qHS; limit use to 10-14 days
Restoril (temazepam) adverse (side) effects
1-10%
Drowsiness (9.1%)
Dizziness (4.5%)
Lethargy (4.5%)
Hangover (2.5%)
Diarrhea (1.7%)
Euphoria (1.5%)
Weakness (1.4%)
Confusion (1.3%)
Vertigo (1.2%)
< 1%
Amnesia
Angioedema
Blood dyscrasias
Sleep-related behavior (eg, sleep driving, sleep cooking, sleep eating)
Ataxia
Warnings
Contraindications
Documented hypersensitivity
Acute alcohol intoxication
Narrow-angle glaucoma (questionable)
Caution
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 and 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)
Pregnancy categories
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.
Pharmacology of Restoril (temazepam)
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.
Absorption
Peak plasma time: 2-3 hr
Peak plasma concentration: 260-210 ng/mL
Distribution
Protein bound: 96%
Vd: 1.4 L/kg
Metabolism
Metabolized by CYP3A4 (minor), glucuronic acid conjugation
Metabolites: Inactive
Elimination
Half-life elimination: 9.5-12.4 hr
Excretion: Urine (80-90%)