Dosing and uses of Doral (quazepam)
Adult dosage forms and strengths
tablet: Schedule IV
- 7.5mg
- 15mg
Insomnia (Hypnotic)
Initial: 15 mg PO qHs
Maintenance: 7.5-15 mg PO qHs
May reduce dose after 1-2 nights
Renal Impairment
Caution; monitor for signs of overdose like excessive sedation or impaired coordination
Hepatic Impairment
Caution; monitor for signs of overdose like excessive sedation or impaired coordination
Pediatric dosage forms and strengths
Safety & efficacy not established
Geriatric dosage forms and strengths
Caution; use lower dose of 7.5 mg initially
Doral (quazepam) adverse (side) effects
>10%
Drowsiness (12%)
1-10%
Dizziness
Xerostomia
Dyspepsia
Fatigue
Headache
Hangover
Warnings
Contraindications
Documented hypersensitivity
Acute alcohol intoxication
Myasthenia gravis (allowable in limited circumstances)
Narrow angle glaucoma (questionable)
Severe respiratory depression
Depressed neuroses, psychotic reactions
IV use in shock, coma, depressed respiration, patients who recently received other respiratory depressants
Cautions
Use caution in COPD, sleep apnea, renal/hepatic disease, impaired gag reflex, respiratory disease, open-angle glaucoma (questionable), depression, suicide ideation
May impair ability to perform hazardous tasks
Hyperactive or aggressive behavior reported
Sleep-driving may occur (discontinue)
Use caution in patients with history of drug abuse or acute alcoholism; tolerance, psychological and physical dependence may occur with prolonged use
Pregnancy and lactation
Pregnancy category: d
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 Doral (quazepam)
Mechanism of action
Depresses all levels of CNS (eg, limbic and reticular formation), by increasing neuronal permeability to chloride ions may increase inhibitory activity of GABA on neuronal excitability
Pharmacokinetics
Peak Plasma Time: 2 hr
Peak plasma concentration: 20 ng/mL
Half-life elimination: 39 hr (metabolite 73 hr)
Protein bound: >95%
Metabolism: Glucuronic acid conjugation
Metabolites: 2-oxoquazepam, N-desalkyl-2-oxoquazepam
Excretion: Urine (31%), feces (23%)
