Brand and Other Names:ProSom
- Classes: Sedative/Hypnotics
Dosing & Uses
Dosage Forms & Strengths
tablet: Schedule IV
1-2 mg PO qHS
Use caution; dose adjustment may be necessary
Safety & efficacy not established
Initial dose: 0.5 mg PO qDay in small elderly patients; healthy patients may receive 1 mg
Serious - Use Alternative
Significant - Monitor Closely
Neuromuscular & skeletal weakness
Abnormal coordination (4%)
Abnormal thinking (2%)
Sleep-driving (sleep-cooking, sleep eating, etc) may occur
Drug dependence may occur
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
Use caution in respiratory diseases, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), impaired gag reflex, clinical depression, suicide ideation, patients receiving other CNS depressants concurrently
Use caution in patients with history of drug abuse or acute alcoholism; tolerance, psychological and physical dependence may occur with prolonged use
May cause CNS depression that impairs mental and physical abilities
Hyperactive or aggressive behavior may occur
May impair ability to perform hazardous tasks
Pregnancy & Lactation
Pregnancy Category: X
Lactation: Enters breast milk/contraindicated
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.
Half-Life: 10-24 hr
Peak Plasma Time: 0.5-1.6 hr
Protein Bound: 93%
Half-life elimination: 10-24 h, and peak action is 2 h
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