|Apo®-Flurazepam; Novo-Flupam; PMS-Flupam;
Somnol®; Som Pam®|
Short-term treatment of insomnia
Hypersensitivity to this drug or any component of its formulation
(cross-sensitivity with other benzodiazepines may exist); narrow-angle glaucoma;
Use with caution in elderly or debilitated patients, patients with hepatic
disease (including alcoholics), or renal impairment. Active metabolites with
extended half-lives may lead to delayed accumulation and adverse effects. Use
with caution in patients with respiratory disease, or impaired gag reflex. Avoid
use in patients with sleep apnea.
Use caution in patients with depression, particularly if suicidal risk may be
present. Use with caution in patients with a history of drug dependence.
Benzodiazepines have been associated with dependence and acute withdrawal
symptoms on discontinuation or reduction in dose. Acute withdrawal, including
seizures, may be precipitated in patients after administration of flumazenil to
patients receiving long-term benzodiazepine therapy.
As a hypnotic, should be used only after evaluation of potential causes of
sleep disturbance. Failure of sleep disturbance to resolve after 7-10 days may
indicate psychiatric or medical illness. A worsening of insomnia or the
emergence of new abnormalities of thought or behavior may represent unrecognized
psychiatric or medical illness and requires immediate and careful evaluation.
Benzodiazepines have been associated with anterograde amnesia. Paradoxical
reactions, including hyperactive or aggressive behavior have been reported with
benzodiazepines, particularly in adolescent/pediatric or psychiatric patients.
Does not have analgesic, antidepressant, or antipsychotic properties.
Cardiovascular: Palpitations, chest pain
Central nervous system: Drowsiness, ataxia, lightheadedness, memory
impairment, depression, headache, hangover, confusion, nervousness, dizziness,
falling, apprehension, irritability, euphoria, slurred speech, restlessness,
hallucinations, paradoxical reactions, talkativeness
Dermatologic: Rash, pruritus
Gastrointestinal: Xerostomia, constipation, excessive salivation, heartburn,
upset stomach, nausea, vomiting, diarrhea, increased or decreased appetite,
bitter taste, weight gain or loss, increased salivation
Hematologic: Euphoria, granulocytopenia
Hepatic: Elevated SGOT/SGPT, total bilirubin, alkaline phosphatase,
Neuromuscular & skeletal: Dysarthria, body/joint pain, reflex slowing,
Ocular: Blurred vision, burning eyes, difficulty focusing
Respiratory: Apnea, shortness of breath
Miscellaneous: Diaphoresis, drug dependence
Symptoms of overdose include respiratory depression, hypoactive reflexes,
unsteady gait, hypotension
Treatment for benzodiazepine overdose is supportive. Rarely is mechanical
ventilation required. Flumazenil has been shown to selectively block the binding
of benzodiazepines to CNS receptors, resulting in a reversal of
benzodiazepine-induced CNS depression.
Carbamazepine, rifampin, rifabutin may enhance the metabolism of flurazepam
and decrease its therapeutic effect; consider using an alternative
Cimetidine, ciprofloxacin, clarithromycin, clozapine, CNS depressants,
diltiazem, disulfiram, digoxin, erythromycin, ethanol, fluconazole, fluoxetine,
fluvoxamine, grapefruit juice, isoniazid, itraconazole, ketoconazole, labetalol,
levodopa, loxapine, metoprolol, metronidazole, miconazole, nefazodone,
omeprazole, phenytoin, protease inhibitors like amprenavir and ritonavir,
rifabutin, rifampin, troleandomycin, valproic acid, verapamil may increase the
serum level and/or toxicity of flurazepam; monitor for altered benzodiazepine
Store in light-resistant containers
Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA
neuron at several sites within the central nervous system, including the limbic
system, reticular formation. Enhancement of the inhibitory effect of GABA on
neuronal excitability results by increased neuronal membrane permeability to
chloride ions. This shift in chloride ions results in hyperpolarization (a less
excitable state) and stabilization.
Onset of hypnotic effect: 15-20 minutes
Peak: 3-6 hours
Duration of action: 7-8 hours
Metabolism: In the liver to N-desalkylflurazepam (active)
Half-life: Adults: 40-114 hours
<15 years: Dose not established
>15 years: 15 mg at bedtime
Adults: 15-30 mg at bedtime
Alcohol: Additive CNS effect, avoid use
Respiratory and cardiovascular status
Therapeutic: 0-4 ng/mL (SI: 0-9 nmol/L); Metabolite N-desalkylflurazepam:
20-110 ng/mL (SI: 43-240 nmol/L); Toxic: >0.12
|Dental Health: Local
No information available to require special precautions
Effects on Dental Treatment|
>10% of patients experience dry mouth
Use exactly as directed (do not increase dose or frequency or discontinue
without consulting prescriber); may cause physical and/or psychological
dependence. May take with food to decrease GI upset. While using this
medication, do not use alcohol or other prescription or OTC medications
(especially, pain medications, sedatives, antihistamines, or hypnotics) without
consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless
instructed to restrict fluid intake). You may experience drowsiness, dizziness,
lightheadedness, or blurred vision (use caution when driving or engaging in
tasks requiring alertness until response to drug is known); dry mouth, nausea or
vomiting (small frequent meals, frequent mouth care, chewing gum, or sucking
lozenges may help); difficulty urinating (void before taking medication); or
altered libido (resolves when medication is discontinued). Report CNS changes
(confusion, depression, increased sedation, excitation, headache, abnormal
thinking, insomnia, or nightmares, memory impairment, impaired coordination);
muscle pain or weakness; difficulty breathing; persistent dizziness, chest pain,
or palpitations; alterations in normal gait; vision changes; ringing in ears; or
ineffectiveness of medication. Pregnancy/breast-feeding precautions:
Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month
following therapy. Consult prescriber for instruction on appropriate barrier
contraceptive measures. This drug may cause severe fetal defects. Breast-feeding
is not recommended.
Provide safety measures (ie, side rails, night light, and call button);
remove smoking materials from area; supervise ambulation; avoid abrupt
discontinuance in patients with prolonged therapy or seizure
Capsule, as hydrochloride: 15 mg, 30 mg
Maletta G, Mattox KM, and Dysken M,
"Guidelines for Prescribing Psychoactive Drugs in the Elderly: Part 1,"
Geriatrics, 1991, 46(9):40-7.
Reidenberg MM, Levy M, Warner H, et al,
"Relationship Between Diazepam Dose, Plasma Level, Age, and Central Nervous System Depression,"
Clin Pharmacol Ther, 1978, 23(4):371-4.
Ruff RL, Kutt H, and Hafler D, "Prolonged Benzodiazepine Coma," N Y State
J Med, 1981, 81(5):776-7.
"Adult Respiratory Distress Syndrome Associated With Flurazepam Overdose," J
R Soc Med, 1985, 78(1)1:74-5.
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