Flurazepam

Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. 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 undertaken concomitantly with appropriate evaluation of the patient. Flurazepam, a gamma-aminobutyric (GABA A ) agonist, is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Flurazepam, like other central nervous system agents of the 1,4-benzodiazepine class, presumably exerts its effects by binding to stereo-specific receptors at several sites within the central nervous system (CNS). The exact mechanism of action is unknown.

Use the lowest dose effective for the patient. Recommended initial dose is 15 mg for women and 15 mg or 30 mg for men. Elderly or debilitated patients: recommended dose is 15 mg.

Flurazepam hydrochloride capsules are contraindicated in patients with known hypersensitivity to flurazepam or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of flurazepam. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should not be rechallenged with flurazepam. Hypersensitivity to flurazepam or other benzodiazepines.

Boxed warning: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. CNS depressant effects: Impaired alertness and motor coordination, including risk of falling. Daytime impairment. Caution patients against driving and other activities requiring complete mental alertness. 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. Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.

The following serious adverse reactions are discussed in greater detail in other sections of the label: Risks from Concomitant Use with Opioids Abuse, Misuse, and Addiction Dependence and Withdrawal Reactions CNS-depressant effects and next-day impairment Severe Anaphylactic and Anaphylactoid Reactions Abnormal thinking and behavior changes, and complex behaviors Worsening of depression Neonatal Sedation and Withdrawal Syndrome Adverse reactions: dizziness, drowsiness, light-headedness, staggering, ataxia, falling.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, and death. CNS Depressants: Downward dose adjustment may be necessary due to additive effects.

Store at 20° to 25°C (68° to 77°F). Protect from light and moisture.