Short-term management of insomnia. Has been used effectively for periods up to 4 weeks in duration.
Has been used effectively in individuals with difficulty in falling asleep, nocturnal awakenings, and/or early morning awakening.
May exhibit carryover effect (i.e., more effective on second, third, and fourth nights of use than on first night) because of accumulation of active metabolite. Effect may persist on first and sometimes second night after discontinuance.
Because of long half-life, may be more likely to result in residual sedative effects and in impaired psychomotor and mental performance during continued therapy, although partial tolerance to these effects can occur. Differences among hypnotics in residual and cumulative CNS depressant effects may be particularly important in geriatric patients, those with potentially impaired elimination of the drugs, and those whose job or life-style requires unimpaired intellectual or psychomotor function.
Dosage and Administration
General
Use hypnotics only when able to get a full night's sleep before being active again.
Use the smallest effective dose (especially in geriatric or debilitated patients and in those with liver disease or low serum albumin).
Avoid prolonged administration.
Reevaluate patient's condition if hypnotic use exceeds 2–3 weeks.
Avoid abrupt discontinuance in patients who have received prolonged therapy (e.g., several months) because of potential for precipitating withdrawal manifestations. Gradually taper dosage.
Many manufacturers state that benzodiazepines are contraindicated in patients with acute angle-closure glaucoma (but may be administered to patients with open-angle glaucoma receiving appropriate therapy); however, clinical rationale for this contraindication has been questioned.
Warnings/Precautions
Warnings
Fetal/Neonatal Morbidity and Mortality
May cause fetal harm; avoid use of benzodiazepines as hypnotics during pregnancy. If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.
Adequate Patient Evaluation
Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.
Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric and/or medical condition.
Complex Sleep-related Behaviors
Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug with no memory of the event), making phone calls, or preparing and eating food, while asleep.
Adverse Psychiatric Events
Abnormal thinking and behavioral changes (e.g., aggressiveness, uncharacteristic extroversion, bizarre behavior, agitation, hallucinations, depersonalization, amnesia) may occur in patients receiving benzodiazepines.
Immediately evaluate any new behavioral sign or symptom.
CNS Depression
Performance of activities requiring mental alertness and physical coordination may be impaired.
Concurrent use of other CNS depressants may cause additive or potentiated CNS depression. (See Specific Drugs under Interactions.)
Dependence and Abuse Potential
Psychologic and physical dependence may occur following prolonged use.
Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.
Tolerance and Withdrawal Effects
Tolerance may occur following prolonged benzodiazepine use.
Abrupt discontinuance may result in symptoms of withdrawal (similar to barbiturates or alcohol).
Sensitivity Reactions
Potential risk of anaphylaxis and angioedema; may occur even with the first dose of drug.
General Precautions
Suicide
Use with caution in depressed patients; potential for suicidal tendencies. Prescribe and dispense drug in the smallest feasible quantity.
Respiratory Effects
Use with caution in patients with compromised pulmonary function.
Specific Populations
Pregnancy
Category X. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
If used during the last weeks of pregnancy, potential for neonatal CNS depression.
Lactation
Benzodiazepines generally are distributed into milk; not known whether flurazepam is distributed into milk, but distribution into milk should be expected.
Pediatric Use
Safety and efficacy not established in children <15 years of age.
Geriatric Use
Potential increased sensitivity (increased risk of oversedation, dizziness, confusion, and/or ataxia); use low initial dose and monitor closely.
Half-life of desalkylflurazepam is prolonged following multiple doses in geriatric men and women and after single-dose administration in geriatric men.
Hepatic Impairment
Use with caution. Use reduced dosage.
Renal Impairment
Use with caution.
Common Adverse Effects
Dizziness, drowsiness, lightheadedness, staggering, ataxia, falling (particularly in geriatric or debilitated patients).
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