| Drug Index |
| GENERIC NAME : |
| flurazepam |
| BRAND NAMES : |
| Dalmane capsules (15 mg, 30 mg) |
| STREET NAMES : |
| downers, benzo's, tranq's |
| BRIEF DESCRIPTION : |
| Flurazepam is categorized as a central nervous system sedative/hypnotic (tranquilizer). It belongs to a class of drugs known as benzodiazepines, which are the most widely prescribed medications that affect central nervous system function. Flurazepam hydrochloride is rapidly absorbed from the G.I. tract. Flurazepam is rapidly metabolized in the liver and is excreted primarily in the urine. Peak flurazepam plasma concentrations occur at 30 to 60 minutes post-dosing. The harmonic mean apparent half-life (the time it takes to eliminate half of the drug from the blood stream) of flurazepam is 2.3 hours. The N1-hydroxyethyl-flurazepam was measurable only during the early hours after a 30 mg dose and was not detectable after 24 hours. The major metabolite in blood was N1-desalkyl-flurazepam which reached steady-state (plateau) levels after 7 to 10 days of dosing, at levels approximately five- to sixfold greater than the 24-hour levels observed on Day 1. The half-life of elimination of N1-desalkyl-flurazepam ranged from 47 to 100 hours. The major urinary metabolite is conjugated N1-hydroxyethyl-flurazepam which accounts for 22 to 55 percent of the dose. Less than 1% of the dose is excreted in the urine as N1-desalkyl-flurazepam. |
| INDICATIONS FOR USE : |
| Flurazepam hydrochloride is a hypnotic (sleep inducing) agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Flurazepam hydrochloride can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have objectively determined that flurazepam hydrochloride is effective for at least 28 consecutive nights of drug administration. Since insomnia is often transient and intermittent short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be under-taken with appropriate evaluation of the patient by a physician. |
| ABUSE AND ADDICTIVE POTENTIAL : |
| Flurazepam is a short acting benzodiazepine and demonstrates potential for dependence (addiction). This is especially true in individuals with a history of drug addiction or alcoholism. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving flurazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence. In general, flurazepam should be prescribed for short periods of time (less than 30 days). Extension of the treatment period should not take place without reevaluation of the need for continued therapy. Withdrawal can appear following cessation of recommended doses. Generally speaking, the longer the medication is used and/or the higher the dose the more withdrawal symptoms may occur. Abrupt discontinuation should be avoided if it has been used for several consecutive months. Tolerance can occur in some individuals after taking the medication for several weeks or months. This means that dosages prescribed for treatment may need to be increased some over time to achieve the therapeutic response. It also means that individuals who have become addicted to flurazepam will need to progressively increase the dosage to achieve the desired mood state that the addict is seeking. Addicted individuals often take several times the recommended dosage. |
| OVERDOSAGE : |
Manifestations of overdoseage may include: • somnolence (extreme drowsiness or deep, prolonged sleep) • confusion • slurred speech • impaired coordination • diminished reflexes • coma • death Emergency medical treatment is advised if overdose is suspected. |
| CAUTIONS : |
| Flurazepam should not be used simultaneously with alcohol or any other central nervous system depressant drugs. Taken together, these drugs can potentiate the potency and effect of each drug. Precaution should be observed in using this medication in patients who have impaired kidney or liver function. Also, in geriatric patients the half-life of elimination of the drug may be extended several hours, requiring careful monitoring and possibly a lower dosage range of prescribing medication. If flurazepam is given concomitantly with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of all agents. Always check first with a physician or pharmacist before taking estazolam while taking any other prescription medications. Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs. Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative hypnotics appears to increase the risk of such behaviors, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patients and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events. Withdrawal symptoms, similar in character to those noted with other benzodiazepines, barbiturates and alcohol (e.g., convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of flurazepam. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Patients with a history of seizures, regardless of their concomitant antiseizure drug therapy, should not be withdrawn abruptly from benzodiazepines. Consequently, after extended therapy, abrupt discontinuation should generally be done under the supervision of a physician and often involves tapering the medication slowly and/or use of other medications to manage withdrawal symptoms. |
| SIDE EFFECTS : |
| Dizziness, drowsiness, light-headedness, staggering, ataxia and falling have occurred, particularly in elderly or debilitated persons., have been reported. Also reported were headache, heartburn, upset stomach, nausea, vomiting, diarrhea, constipation, gastrointestinal pain, nervousness, talkativeness, apprehension, irritability, weakness, palpitations, chest pains, body and joint pains and genitourinary complaints. There have also been rare occurrences of leucopenia/granulocytopenia (lowering of white blood cell count), sweating, flushes, difficulty in focusing, blurred vision, burning eyes, faintness, hypotension (abnormally low blood pressure), shortness of breath, pruritus (itching), skin rash, dry mouth, bitter taste, excessive salivation, anorexia (loss of appetite), euphoria, depression, slurred speech, confusion, restlessness, hallucinations, and elevated liver enzymes. Paradoxical reactions (reactions that are opposite to those expected), such as excitement, stimulation and hyperactivity, have also been reported in rare instances. *This is not a complete list of side effects and others may occur. Tell your doctor or pharmacist about |
| FOR MORE INFORMATION : |
| *this is a condensed description of this medication. For more details check with your physician, pharmacist, or other resources such as The Physicians' Desk Reference (PDR) or http://www.drugs.com. |
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