VA Class:CN302

AHFS Class:

• Benzodiazepines 28:24.08

Generic Name(s):

• Flurazepam Hydrochloride

Associated Monographs

• Benzodiazepines General Statement

Flurazepam hydrochloride is a benzodiazepine.

Flurazepam shares the actions of other benzodiazepines and is used as a hypnotic agent in the short-term treatment of insomnia for periods up to 4 weeks in duration. Prolonged use of hypnotics is usually not indicated and should be undertaken only upon further evaluation of the patient. The possibility that insomnia may be a symptom of an underlying condition for which there may be a more specific treatment should be considered.

Administration

Flurazepam hydrochloride is administered orally at bedtime.

Dosage

Dosage of flurazepam hydrochloride must be individualized, and the smallest effective dosage should be used (especially in geriatric or debilitated patients or in those with liver disease or low serum albumin). Prolonged administration of flurazepam should be avoided.

The usual adult dose of flurazepam hydrochloride is 30 mg; however, 15 mg may be adequate in some patients. In geriatric or debilitated patients, an initial dose of 15 mg should be used. In patients who have received prolonged (e.g., for several months) flurazepam hydrochloride therapy, abrupt discontinuance of the drug should be avoided since manifestations of withdrawal can be precipitated; if the drug is to be discontinued in such patients, it is recommended that dosage be gradually tapered.

Precautions

A boxed warning has been included in the prescribing information for all benzodiazepines describing the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions associated with all drugs in this class.900 Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs.900 Frequent follow-up with patients receiving benzodiazepines is important.900 Reassess patients regularly to manage their medical conditions and any withdrawal symptoms.900 Clinicians should assess a patient's risk of abuse, misuse, and addiction. 900 Standardized screening tools are available ([Web]).900 To reduce the risk of acute withdrawal reactions, use a gradual dose taper when reducing the dosage or discontinuing benzodiazepines.900 Take precautions when benzodiazepines are used in combination with opioid medications.900

Flurazepam shares the toxic potentials of the benzodiazepines, and the usual precautions of benzodiazepine administration should be observed. (See Cautions in the Benzodiazepines General Statement 28:24.08.)

Pediatric Precautions

Safety and efficacy of flurazepam in children younger than 15 years of age have not been established.

Chemistry and Stability

Chemistry

Flurazepam hydrochloride is a benzodiazepine. Flurazepam occurs as an off-white to yellow, crystalline powder which may have a slight odor. The drug is freely soluble in water and in alcohol and has pK_a values of 1.9 and 8.16.

Stability

Commercially available flurazepam hydrochloride capsules should be stored in tight, light-resistant containers at a temperature less than 40°C, preferably at 15-30°C.

Additional Information

For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, chronic toxicity, acute toxicity, drug interactions, laboratory test interferences, and dosage and administration of flurazepam, see the Benzodiazepines General Statement 28:24.08.

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