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flurazepam (Dalmane, Som Pam, Somnol)

 

Classes: Sedative/Hypnotics

Dosing and uses of Dalmane, Som Pam (flurazepam)

 

Adult dosage forms and strengths

capsule: Schedule IV

  • 15mg
  • 30mg

 

Insomnia

15-30 mg PO qHs

 

Pediatric dosage forms and strengths

<15 years old: not recommended

 

Geriatric dosage forms and strengths

Not drug of choice in elderly because of long-acting metabolite; associated with increased falls

 

Insomnia

15 mg PO qHs

 

Dalmane, Som Pam (flurazepam) adverse (side) effects

Frequency not defined

Common

  • Ataxia
  • Dizziness
  • Drowsiness
  • Lethargy
  • Light-headedness

Less Common

  • Chest pain, palpitations
  • Headache, irritability, nervousness, weakness
  • GI complaints
  • Myalgia
  • GU complaints

Rare

  • Elevations of AST, ALT, bilirubin (T&D), alk phos

 

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

Lactation

 

Cautions

Use caution in COPD, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicide ideation

May impair ability to perform hazardous tasks

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: X

Lactation: Excretion in milk unknown; not recommended

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 Dalmane, Som Pam (flurazepam)

Mechanism of action

Long-acting benzodiazepine that depresses all levels of CNS (eg, limbic and reticular formation), possibly by increasing activity of GABA.

 

Pharmacokinetics

Metabolism: Glucuronic acid conjugation

Metabolites: Desalkylflurazepam, N-1-hydroxyethylflurazepam

Excretion: Urine

Half-life elimination: 48-120 h

Peak plasma time: 0.5-3 hr

Peak plasma concentration: 0.5-4 ng/mL