Flurazepam
Brand name: Dalmane
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Drug monograph
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Contents
Pharmacology
Indications
Contraindications
Warnings
Precautions
Adverse Effects
Overdose
Dosage
Supplied
Research
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Pharmacology
Hypnotic
Flurazepam, a benzodiazepine derivative, is a hypnotic agent which does not appear to decrease dream time as measured by rapid eye movements (REM). Furthermore, it decreases sleep latency and number of awakenings for a consequent increase in total sleep time.
In controlled sleep laboratory studies of 20 human insomniac subjects utilizing all night electroencephalograph (EEG), electromyograph (EMG), and electro-oculograph (EOG) recordings, flurazepam usually induced sleep within 22 minutes and usually provided 7 to 8 hours of sleep.
Flurazepam is rapidly absorbed from the gastrointestinal tract and is rapidly metabolized. Both hydroxyethyl flurazepam (the major metabolite) and N-desalkyl flurazepam are active. The N-desalkyl metabolite is slowly excreted in the urine as the conjugated form. Because of the long half-life of this metabolite (47 to 100 hours), peak hypnotic effect of flurazepam may be reached after 2 to 3 nights of use.
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Indications
Insomnia, characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakening. For short-term and intermittent use in patients with recurring insomnia and poor sleeping habits; however, the safety and efficacy of long-term use has not been established.
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Contraindications
Known hypersensitivity to benzodiazepines. Since clinical investigations of flurazepam have not been carried out in children, currently it is not recommended for use in children under 15 years of age.
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Warnings
Pregnancy and Lactation:
The safety of the use of flurazepam in pregnancy has not been established. Therefore, flurazepam is not recommended for use during pregnancy or lactation. Several studies have suggested an increased risk of congenital malformations associated with the use of the benzodiazepines chlordiazepoxide and diazepam, and meprobamate during the first trimester of pregnancy. Since flurazepam is also a benzodiazepine derivative, its administration is rarely justified in women of childbearing potential. If the drug is prescribed for a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation of the drug if she intends to become or suspects that she is pregnant.
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Precautions
Geriatrics:
In elderly and debilitated patients, the initial dosage should be limited to 15 mg to preclude the development of oversedation, dizziness and/or ataxia.
Use in Emotional Disorders:
The usual precautions are indicated for severely depressed patients or where there is any evidence of latent depression, particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.
Potentiation of Drug Effects:
Careful consideration should be given if flurazepam is to be combined with other drugs having known hypnotic or CNS depressant effects, because the pharmacological action of these agents might potentiate the action of flurazepam. Patients should be advised against the simultaneous ingestion of alcohol and other CNS depressant drugs during flurazepam therapy.
Physical and Psychological Dependence:
Although physical and psychological dependence have not been reported or observed in patients taking recommended doses of flurazepam, at the present time the potential for addiction is not known. As with any hypnotic, caution must be exercised in administering flurazepam to individuals known to be addiction prone or those whose history suggests they may increase the dosage on their own initiative.
Occupational Hazards:
General:
Patients should be cautioned against engaging in activities requiring complete mental alertness, such as in operating machinery or driving a motor vehicle, shortly after ingesting the drug.
Should flurazepam be used repeatedly, periodic blood counts and liver and kidney function tests should be performed. The usual precautions should be observed in patients with impaired renal or hepatic function.
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Adverse Effects
The most common adverse effects are dizziness, drowsiness, lightheadedness and ataxia. These adverse effects are particularly common in elderly and debilitated patients. (See Precautions). Severe sedation, lethargy, disorientation, probably indicative of drug intolerance or overdosage, have been reported.
Isolated instances of headache, heartburn, upset stomach, nausea, vomiting, constipation, diarrhea, gastrointestinal pain, nervousness, apprehension, irritability, weakness, palpitations, chest pains, and genitourinary complaints have been reported. However, in controlled studies, these appeared as often or more often with placebo than with the active drug.
There have also been rare occurrences of sweating, flushes, difficulty in focusing, blurred vision, faintness, hypotension, shortness of breath, pruritus, skin rash, dry mouth, bitter taste, excessive salivation, anorexia, euphoria, depression, slurred speech, confusion, restlessness, and hallucinations. Elevated AST (SGOT), ALT (SGPT), total and direct bilirubins, and alkaline phosphatase have been observed. Paradoxical reactions, such as excitement, stimulation and hyperactivity, have also been reported in rare instances.
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Overdose
Symptoms:
Somnolence, confusion, coma.
Treatment:
Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension and CNS depression may be combated by judicious use of appropriate therapeutic agents. The value of dialysis has not been determined. If excitation occurs in patients following flurazepam overdosage, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.
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Dosage
Should be individualized for maximal beneficial effects. For severe insomnia, the usual adult dosage is 30 mg before retiring. In elderly and/or debilitated patients, therapy should be initiated with 15 mg until individual responses are determined.
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Supplied
15 mg:
Each orange and ivory No. 2 hard gelatin capsule imprinted {ENCR:ROCHEoverC} and {ENCR
ALMANEover15} contains: Flurazepam HCl 15 mg. Also contains lactose 276 mg. Energy: 5.0 kJ (1.2 kcal). Nonmedicinal ingredients: Allura red AC, cornstarch, erythrosine, gelatin, lactose, magnesium stearate, methylparaben, potassium sorbate, propylparaben, quinoline yellow WS, sunset yellow FCF, talc. Gluten-free, sodium-free, sulfite-free and tartrazine-free. Bottles of 100 and 500.
30 mg:
Each red and ivory No. 2 hard gelatin capsule imprinted with black ink {ENCR:ROCHEoverC} and {ENCR
ALMANEover30} contains: Flurazepam HCl 30 mg. Also contains lactose 263 mg. Energy: 5.0 kJ (1.2 kcal). Nonmedicinal ingredients: Allura red AC, brillant blue FCF, cornstarch, erythrosine, gelatin, lactose, magnesium stearate, methylparaben, quinoline yellow WS, potassium sorbate, propylparaben, sodium salt, sunset yellow FCF. Gluten-free, sodium-free, sulfite-free and tartrazine-free. Bottles of 100 and 500.
Store in a tightly closed, light-resistant container. Store at 15 to 30°C.
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