Flurazepam Hydrochloride
Capsule · Oral
Current shortage
Flurazepam Hydrochloride, Capsule, 30 mg (NDC 62135-737-30) – Available (Chartwell Molecular Holdings LLC, updated Sep 15, 2026)
Flurazepam Hydrochloride, Capsule, 30 mg (NDC 62135-737-90) – Available (Chartwell Molecular Holdings LLC, updated Sep 15, 2026)
Flurazepam Hydrochloride, Capsule, 15 mg (NDC 62135-736-30) – Available (Chartwell Molecular Holdings LLC, updated Sep 15, 2026)
Flurazepam Hydrochloride, Capsule, 15 mg (NDC 62135-736-90) – Available (Chartwell Molecular Holdings LLC, updated Sep 15, 2026)
Uses
Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings [see Clinical Studies ( 14 ) ]. 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. ( 1 )
Dosage and administration
Use the lowest dose effective for the patient. Recommended initial dose is 15 mg for women and 15 mg or 30 mg for men. ( 2.1 ) Elderly or debilitated patients: recommended dose is 15 mg. ( 2.2 ) 2.1 Dosage in Adults Use the lowest dose effective for the patient, as important adverse effects of flurazepam hydrochloride capsules are dose related. The recommended initial dose is 15 mg for women and either 15 mg or 30 mg for men. The 15 mg dose can be increased to 30 mg if necessary for efficacy. The recommended initial doses for women and men are different because flurazepam clearance is lower in women [see Pharmacokinetics ( 12.3 ) ]. 2.2 Dosage in Elderly or Debilitated Patients Elderly or debilitated patients may be especially sensitive to flurazepam. Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly or debilitated patients, it is recommended that in such patients the dosage be limited to 15 mg. Staggering and falling have also been reported, particularly in geriatric patients [see Warnings and Precautions ( 5.2 ) ]. 2.3 Discontinuation or Dosage Reduction of Flurazepam Hydrochloride Capsules To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [ see Warnings and Precautions ( 5.3 ) and Drug Abuse and Dependence ( 9.3 ) ].
Dosage forms and strengths
Flurazepam Hydrochloride Capsules, USP are available containing either 15 mg or 30 mg of Flurazepam Hydrochloride, USP. Flurazepam Hydrochloride Capsules, USP 15 mg are Size #2 hard gelatin capsules, Blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 28 ” on the body with black ink, filled with white to off-white powder. Flurazepam Hydrochloride Capsules, USP 30 mg are Size #2 hard gelatin capsules, Blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 29 ” on the body with black ink, filled with white to off-white powder. 15 mg and 30 mg capsules. ( 3 )
Contraindications
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. ( 4 )
Warnings and precautions
5 WARNINGS AND PRECAUTIONS 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. ( 5.4 ) 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. ( 5.5 ) Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ( 5.6 ) Sleep driving and other complex behaviors while not fully awake: Risk increases with dose and concomitant CNS depressants and alcohol. Immediately evaluate any new onset behavioral changes. ( 5.7 ) Worsening of depression or suicidal thinking may occur: Prescribe the least number of capsules feasible to avoid intentional overdose. ( 5.8 ) Neonatal Sedation and Withdrawal Syndrome: Flurazepam use during pregnancy can result in neonatal sedation and/or neonatal withdrawal. ( 5.9 ) 5.1 Risks from Concomitant Use of Opioids Concomitant use of benzodiazepines, including flurazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe flurazepam concomitantly with opioids, prescribe the 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 the risks of respiratory depression and sedation when flurazepam is used with opioids [see Drug Interactions ( 7 )]. 5.2 Abuse, Misuse, and Addiction The use of benzodiazepines, including flurazepam hydrochloride capsules, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the 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 [see Drug Abuse and Dependence ( 9.2 ) ]. Before prescribing flurazepam hydrochloride capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of flurazepam hydrochloride capsules, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of flurazepam hydrochloride capsules along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. 5.3 Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules or reduce the dosage (a patient-specific plan should be used to taper the dose) [see Dosage and Administration ( 2.3 )] . Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions: The continued use of benzodiazepines, including flurazepam hydrochloride capsules, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of flurazepam hydrochloride capsules after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [ see Drug Abuse and Dependence ( 9.3 ) ]. Protracted Withdrawal Syndrome: In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [ see Drug Abuse and Dependence ( 9.3 ) ]. 5.4 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, have been reported. Flurazepam 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 (i.e., less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of flurazepam may develop, patients using flurazepam 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 (e.g., other benzodiazepines, opioids, tricyclic antidepressants, alcohol). Downward dose adjustment of flurazepam and concomitant CNS depressants should be considered. The potential for adverse drug interactions continues for several days following discontinuation of flurazepam, until serum levels of psychoactive metabolites decline. Use of flurazepam with other sedative-hypnotics is not recommended.
Side effects
The following serious adverse reactions are discussed in greater detail in other sections of the label: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 ) ] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 ) ] CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.4 )] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions ( 5.6 )] Abnormal thinking and behavior changes, and complex behaviors [see Warnings and Precautions ( 5.7 )] Worsening of depression [see Warnings and Precautions ( 5.8 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.9 )] Adverse reactions: dizziness, drowsiness, light-headedness, staggering, ataxia, falling. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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 leukopenia, granulocytopenia, sweating, flushes, difficulty in focusing, blurred vision, burning eyes, faintness, hypotension, shortness of breath, pruritus, skin rash, dry mouth, bitter taste, excessive salivation, anorexia, euphoria, depression, slurred speech, confusion, restlessness, hallucinations and elevated SGOT, SGPT, total and direct bilirubin elevations, and elevated alkaline phosphatase.
Drug interactions
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, and death. ( 7.1 ) CNS Depressants: Downward dose adjustment may be necessary due to additive effects. ( 7.2 ) 7.1 Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the 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. 7.2 CNS Depressants Benzodiazepines, including flurazepam, produce additive CNS depressant effects when co-administered with ethanol or other CNS depressants (e.g., psychotropic medications, anticonvulsants, antihistamines). Downward dose adjustment of flurazepam and/or concomitant CNS depressants may be necessary because of additive effects.
Use in specific populations
Lactation: Breastfeeding not recommended. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including flurazepam, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/ . Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [ see Warnings and Precautions ( 5.9 ) and Clinical Considerations]. Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to flurazepam during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to HALCION during pregnancy for signs of withdrawal. Manage these neonates accordingly [see Warnings and Precautions ( 5.9 )]. Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data Administration of flurazepam 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 that possibility of adverse developmental effects (including long-term effects on neurobehavioral and immunological function) following prenatal exposure. 8.2 Lactation Risk Summary There are no data on the presence of flurazepam in human or animal milk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. The effects of flurazepam on milk production are unknown. Because of the flurazepam’s long half-life, the potential for flurazepam to accumulate in breast milk, and the potential for serious adverse reactions, including sedation and withdrawal symptoms in breastfed infants, advise patients that breastfeeding is not recommended during treatment with flurazepam. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Flurazepam may cause confusion and over-sedation in the elderly. Elderly patients generally should be started on a low dose of flurazepam and observed closely. Elderly or debilitated patients may be more sensitive to benzodiazepines, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Overdosage
Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal [see Warnings and Precautions ( 5.2 )] . Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information. Consider contacting a poison center (1-800-222-1222), poisoncontrol.org , or a medical toxicologist for additional overdosage management recommendations.
Description
Flurazepam Hydrochloride, USP is chemically 7-chloro-1-[2-(diethylamino)ethyl]-5-( ο -fluro-phenyl)-1,3-dihydro-2 H -1,4- benzodiazepin-2-one dihydrochloride. It is a pale yellow, crystalline compound, freely soluble in alcohol and very soluble in water. It has a molecular weight of 460.81 and the following structural formula: Each capsule, for oral administration, contains either 15 mg or 30 mg of Flurazepam Hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue #1, FD&C Red #3, gelatin, mannitol, magnesium stearate, talc, and titanium dioxide. Additionally, capsule shells of 15 mg and 30 mg are imprinted with black pharmaceutical ink. The compositions of the black pharmaceutical ink are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. flurazepam-hydrochloride-structure
How supplied
Flurazepam Hydrochloride Capsules, USP are available containing either 15 mg or 30 mg of Flurazepam Hydrochloride, USP. Flurazepam Hydrochloride Capsules, USP 15 mg are Size #2 hard gelatin capsules, Blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 28 ” on the body with black ink, filled with white to off-white powder. They are available as follows, Bottle of 30's - NDC 62135-736-30 Bottle of 90’s - NDC 62135-736-90 Flurazepam Hydrochloride Capsules, USP 30 mg are Size #2 hard gelatin capsules, Blue opaque cap with white opaque body, imprinted with “ CE ” on the cap and “ 29 ” on the body with black ink, filled with white to off-white powder. They are available as follows, Bottle of 30's - NDC 62135-737-30 Bottle of 90’s - NDC 62135-737-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Patient information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Risks from Concomitant Use with Opioids: Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when flurazepam hydrochloride capsules are used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )]. Abuse, Misuse, and Addiction: Inform patients that the use of flurazepam hydrochloride capsules, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances . Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions ( 5.2 ) and Drug Abuse and Dependence ( 9.2 )]. Withdrawal Reactions: Inform patients that the continued use of flurazepam hydrochloride capsules may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of flurazepam hydrochloride capsules may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of flurazepam hydrochloride capsules may require a slow taper [see Warnings and Precautions ( 5.3 ) and Drug Abuse and Dependence ( 9.3 )]. CNS Depressant Effects and Next-Day Impairment: Tell patients that flurazepam can cause next-day impairment, even in the absence of symptoms. Caution patients against driving or engaging in other hazardous activities or activities requiring complete mental alertness when using flurazepam. Tell patients that daytime impairment may persist for several days following discontinuation of flurazepam. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions ( 5.4 )]. Abnormal Thinking and Behavior Change: Instruct patients that sedative hypnotics can cause abnormal thinking and behavior change, including “sleep-driving” and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients to call you immediately if they develop any of these symptoms [see Warnings and Precautions ( 5.7 )]. Severe Allergic Reactions: Inform patients that severe allergic reactions can occur from flurazepam. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if these occur. Worsening of Depression: Tell patients that flurazepam can worsen depression, and to immediately report any suicidal thoughts [see Warnings and Precautions ( 5.8 )]. Alcohol and Other Drugs: Ask patients about alcohol consumption, medicines they are taking now, and drugs they may be taking without a prescription. Advise patients that alcohol generally should not be used during treatment with flurazepam. Pregnancy: Advise pregnant females that use flurazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 )] . Instruct patients to inform their healthcare provider if they are pregnant. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to flurazepam during pregnancy [see Use in Specific Populations ( 8.1 )]. Lactation Advise patients that breastfeeding is not recommended during treatment with flurazepam [see Use in Specific Populations ( 8.2 )] . Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Revised: 12/2023 L71652 Print Medication Guides at: www.chartwellpharma.com/medguides
Label text from the FDA structured product label by Chartwell RX, LLC (revised Oct 28, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Flurazepam Hydrochloride in 2 products
Flurazepam Hydrochloride NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 62135-736 | Flurazepam Hydrochloride 15 mg/1 Capsule | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-737 | Flurazepam Hydrochloride 30 mg/1 Capsule | Chartwell RX, LLC | ANDA · DEA CIV |
Frequently asked questions
What is Flurazepam Hydrochloride used for?
Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings [see Clinical Studies ( 14 ) ]. 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…
What are the side effects of Flurazepam Hydrochloride?
The following serious adverse reactions are discussed in greater detail in other sections of the label: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 ) ] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 ) ] CNS-depressant effects and next-day impairment [see Warnings and… See the full label for the complete list.
Who makes Flurazepam Hydrochloride?
Flurazepam Hydrochloride is listed by 1 labeler in the FDA NDC directory, including Chartwell RX, LLC.