analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone; if a decision is made to prescribe this drug concomitantly with opioids, prescribe lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation Advise both patients and caregivers about risks of respiratory depression and sedation when this drug is used with opioids Abuse, misuse, and addiction The use of benzodiazepines, including Flurazepam hydrochloride capsules, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death Abuse and misuse of benzodiazepines often (but not always) involve use of doses greater than maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death Before prescribing medication and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (eg, using a standardized screening tool); use particularly in patients at elevated risk, necessitates counseling about risks and proper use of this medication along with monitoring for signs and symptoms of abuse, misuse, and addiction Prescribe lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); and advise patients on proper disposal of unused drug If a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate CNS-depressant effects and next-day impairment Dizziness, drowsiness, light-headedness, staggering, ataxia and falling can occur, particularly in elderly or debilitated persons; severe sedation, lethargy, disorientation and coma, probably indicative of drug intolerance or overdosage, reported This drug is a central nervous system (CNS) depressant and can impair daytime function even when used as prescribed; prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (eg, less than formal psychomotor testing) While pharmacodynamic tolerance or adaptation to some adverse depressant effects of this drug may develop, patients receiving therapy should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness Additive effects occur with concomitant use of other CNS depressants (eg, other benzodiazepines, opioids, tricyclic antidepressants, alcohol) Downward dose adjustment of this drug and concomitant CNS depressants should be considered; the potential for adverse drug interactions continues for several days following discontinuation of therapy, until serum levels of psychoactive metabolites decline Use with other sedative-hypnotics is not recommended; alcohol generally should not be used during treatment; the risk of next-day psychomotor impairment is increased if this drug is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than recommended dose taken; if coadministered with other CNS depressants Because this drug can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls Need to evaluate for comorbid behavior Because sleep disturbances may be 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 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 Severe anaphylactic or anaphylactoid reactions Rare cases of angioedema involving tongue, glottis, or larynx reported in patients after taking first or subsequent doses of sedative-hypnotics; some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis Some patients have required medical therapy in emergency department; if angioedema involves tongue, glottis, or larynx, airway obstruction may occur and be fatal; patients who develop angioedema after treatment should not be rechallenged with the drug Abnormal thinking and behavior changes Abnormal thinking and behavior changes have been reported in patients treated with sedative-hypnotics including this medication; some of these changes include decreased inhibition (eg, aggressiveness and extroversion that seemed out of character), bizarre behavior, and depersonalization; visual and auditory hallucinations also reported; amnesia, and other neuro-psychiatric symptoms, may occur Paradoxical reactions such as stimulation, agitation, increased muscle spasticity, and sleep disturbances may occur unpredictably Complex behaviors such as "sleep-driving" (eg, driving while not fully awake, with amnesia for the event) have been reported with use of sedative-hypnotics; these behaviors can occur with initial treatment or in patients previously tolerant of this medicaiton or other sedative-hypnotics Although these behaviors can occur with use at therapeutic doses, risk is increased by higher doses or concomitant use of alcohol or other CNS depressants; due to risk to patient and community, this drug should be discontinued if “sleep-driving” occurs Other complex behaviors (eg, preparing and eating food, making phone calls, or having sex) reported in patients who are not fully awake after taking a sedative-hypnotic; as with sleep-driving, patients usually do not remember these events Drug interaction overview Concomitant use of benzodiazepines and opioids increases risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration; benzodiazepines interact at GABAA sites, and opioids interact primarily at mu receptors; when benzodiazepines and opioids are combined, potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists; limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation Benzodiazepines, including this medication, produce additive CNS depressant effects when co-administered with ethanol or other CNS depressants (eg, psychotropic medications, anticonvulsants, antihistamines); downward dose adjustment of flurazepam and/or concomitant CNS depressants may be necessary because of additive effects Pregnancy To provide information regarding effects of in-utero exposure to this drug, physicians are advised to recommend that pregnant patients taking flurazepam enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; this can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves or their caregiver; information on the registry can also be found at website http://www.aedpregnancyregistry.org/ There are no adequate and well-controlled studies in pregnant women; available human data on risk of teratogenicity for benzodiazepines are inconclusive; there is insufficient evidence in humans to assess effect of benzodiazepine exposure during pregnancy or neurodevelopment Administration of benzodiazepines immediately prior to or during childbirth can result in syndrome of hypothermia, hypotonia, respiratory depression, and difficulty feeding In addition, infants born to mothers who have taken benzodiazepines during later stages of pregnancy can develop dependence, and subsequently withdrawal, during postnatal period This drug should be used during pregnancy only if potential benefit justifies the potential risk to fetus Animal data Administration of this medication to pregnant animals did not indicate a risk for adverse effects on morphological development at clinically relevant doses; however, animal data for other benzodiazepines suggest the possibility of adverse developmental effects (including long-term effects on neurobehavioral and immunological function) following prenatal exposure Lactation Manufacturer makes no recommendation regarding use during lactation Unknown if drug excreted into human milk; unknown if drug excreted into animal milk; data not available; effects in nursing infant are unknownPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Long-acting benzodiazepine that depresses all levels of CNS (eg, limbic and reticular formation), possibly by increasing activity of GABA. Pharmacokinetics Metabolism: Glucuronic acid conjugation Metabolites: Desalkylflurazepam, N-1-hydroxyethylflurazepam Excretion: Urine Half-life elimination: 48-120 h Peak plasma time: 0.5-3 hr Peak plasma concentration: 0.5-4 ng/mL No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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