Drugs Details

Drugs Info of Dalmane
Drugs Details
  • Drugs Type  : FDA
  • Date : 13th Jan 2015 01:00 am
  • Brand Name : Dalmane
  • Generic Name : flurazepam (Pronunciation: flure AZ e pam)
Descriptions

Dalmane (flurazepam) is available as capsules containing 15 mg or 30 mg flurazepam hydrochloride. Each 15-mg capsule also contains cornstarch, lactose, magnesium stearate and talc; gelatin capsule shells contain the following dye systems: D&C Red No. 28, FD&C Red No. 40, FD&C Yellow No. 6 and D&C Yellow No. 10. Each 30-mg capsule also contains cornstarch, lactose and magnesium stearate; gelatin capsule shells contain the following dye systems: FD&C Blue No. 1, FD&C Yellow No. 6, D&C Yellow No. 10 and either FD&C Red No. 3 or FD&C Red No. 40.

Flurazepam hydrochloride is chemically 7-chloro-1-[2-(diethylamino)ethyl]-5-(o- fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one dihydrochloride. It is a pale yellow, crystalline compound, freely soluble in USP alcohol and very soluble in water. It has a molecular weight of 460.826 and the following structural formula:

Dalmane (Flurazepam hydrochloride) structural formula illustration

What are the possible side effects of flurazepam (Dalmane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • staggering walk, loss of balance or coordination;
  • agitation, confusion, slurred speech, hallucinations, feelings of extreme happiness or sadness;
  • chest pain, fast or pounding heartbeats, feeling short of breath;
  • fever, chills, body aches, flu symptoms;
  • problems with...

Read All Potential Side Effects and See Pictures of Dalmane »

What are the precautions when taking flurazepam (Dalmane)?

Before taking flurazepam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), mental/mood problems (such as depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol/other substances, personal or family history of sleepwalking, a certain muscle disease (myasthenia gravis).

Since this drug makes you drowsy, do not drive, use machinery,...

Read All Potential Precautions of Dalmane »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Dalmane (flurazepam) is a hypnotic agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Dalmane (flurazepam) can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have objectively determined that Dalmane (flurazepam) is effective for at least 28 consecutive nights of drug administration. 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.

Dosage Administration

Dosage should be individualized for maximal beneficial effects. The usual adult dosage is 30 mg before retiring. In some patients, 15 mg may suffice. In elderly and/or debilitated patients, 15 mg is usually sufficient for a therapeutic response and it is therefore recommended that therapy be initiated with this dosage.

How Supplied

Dalmane (flurazepam hydrochloride) Capsules are available in the following presentations:

15 mg hard gelatin capsules in bottles of 100 (NDC 0187-4051-10), with ICN logo imprinted on the opaque orange cap and Dalmane® (flurazepam) 15 imprinted on the opaque ivory body.

30 mg hard gelatin capsules in bottles of 100 (NDC 0187-4052-10), with ICN logo imprinted on the opaque red cap and Dalmane® (flurazepam) 30 imprinted on the opaque ivory body.

Store at 25ºC (77ºF); excursions permitted to 15Cº-30ºC (59ºF-86ºF). [See USP Controlled Room Temperature]

Valeant Pharmaceuticals North America, Aliso Viejo, CA 92656. Rev. April 2007. FDA rev date: 10/30/2007


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Dizziness, drowsiness, light-headedness, staggering, ataxia and falling have occurred, particularly in elderly or debilitated persons. Severe sedation, lethargy, disorientation and coma, probably indicative of drug intolerance or overdosage, have been reported.

Also 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 bilirubins, and alkaline phosphatase. Paradoxical reactions, eg, excitement, stimulation and hyperactivity, have also been reported in rare instances.

DRUG ABUSE AND DEPENDENCE

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of the drug and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of benzodiazepines. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving flurazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Read the Dalmane (flurazepam) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.

Read the Dalmane Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Because sleep disturbances may be the 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 presents of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the 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. Because some of the important adverse effects of sedative-hypnotics appear to be dose related (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), it is important to use the smallest possible effective dose, especially in the elderly.

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative- hypnotics appears to increase the risk of such behaviors, as does the use of sedative- hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patients and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a "sleep-driving" episode.

Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative- hypnotic. As with sleep-driving, patients usually do not remember these events.

Severe anaphylactic and anaphylactoid reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Dalmane (flurazepam) . 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 the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Dalmane (flurazepam) should not be rechallenged with the drug.

Patients receiving Dalmane (flurazepam) should be cautioned about possible combined effects with alcohol and other CNS depressants. Also, caution patients that an additive effect may occur if alcoholic beverages are consumed during the day following the use of Dalmane (flurazepam) for nighttime sedation. The potential for this interaction continues for several days following discontinuance of flurazepam, until serum levels of psychoactive metabolites have declined.

Patients should also be cautioned about engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities which may occur the day following ingestion of Dalmane (flurazepam) .

Usage in Children: Clinical investigations of Dalmane (flurazepam) have not been carried out in children. Therefore, the drug is not currently recommended for use in persons under 15 years of age.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines. (See DRUG ABUSE AND DEPENDENCE Section.)

Precautions

Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly and debilitated patients, it is recommended that in such patients the dosage be limited to 15 mg. If Dalmane (flurazepam) is to be combined with other drugs having known hypnotic properties or CNS- depressant effects, due consideration should be given to potential additive effects.

The usual precautions are indicated for severely depressed patients or those in whom there is any evidence of latent depression; particularly the recognition that suicidal tendencies may be present and protective measures may be necessary.

The usual precautions should be observed in patients with impaired renal or hepatic function and chronic pulmonary insufficiency.

Geriatric Use: Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly and 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.

Following single-dose administration of flurazepam, the elimination half-life for desalkyl-flurazepam was longer in elderly male subjects compared with younger male subjects, while values between elderly and young females were not significantly different. After multiple dosing, elimination half-life of desalkyl-flurazepam was longer in all elderly subjects compared with younger subjects, and mean steady-state serum concentrations were higher only in elderly male subjects relative to younger subjects (see CLINICAL PHARMACOLOGY: Geriatric Pharmacokinetics).


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Manifestations of Dalmane (flurazepam) overdosage include somnolence, confusion and coma. Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension and CNS depression may be combated by judicious use of appropriate therapeutic agents. The value of dialysis has not been determined. If excitation occurs in patients following Dalmane (flurazepam) overdosage, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be useful in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, should be consulted prior to use.

ContrainDications

Dalmane (flurazepam) is contraindicated in patients with known hypersensitivity to the drug.

Usage in Pregnancy: Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies.

Dalmane (flurazepam) is contraindicated in pregnant women. Symptoms of neonatal depression have been reported; a neonate whose mother received 30 mg of Dalmane (flurazepam) nightly for insomnia during the 10 days prior to delivery appeared hypotonic and inactive during the first 4 days of life. Serum levels of N1-desalkyl-flurazepam in the infant indicated transplacental circulation and implicate this long-acting metabolite in this case. If there is a likelihood of the patient becoming pregnant while receiving flurazepam, she should be warned of the potential risks to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Flurazepam hydrochloride is rapidly absorbed from the GI tract. Flurazepam is rapidly metabolized and is excreted primarily in the urine. Following a single oral dose, peak flurazepam plasma concentrations ranging from 0.5 to 4.0 ng/mL occur at 30 to 60 minutes post-dosing. The harmonic mean apparent half-life of flurazepam is 2.3 hours. The blood level profile of flurazepam and its major metabolites was determined in man following the oral administration of 30 mg daily for 2 weeks. The N1-hydroxyethyl-flurazepam was measurable only during the early hours after a 30-mg dose and was not detectable after 24 hours. The major metabolite in blood was N1-desalkyl-flurazepam, which reached steady-state (plateau) levels after 7 to 10 days of dosing, at levels approximately 5- to 6-fold greater than the 24-hour levels observed on Day 1. The half-life of elimination of N1-desalkyl-flurazepam ranged from 47 to 100 hours. The major urinary metabolite is conjugated N1-hydroxyethyl- flurazepam which accounts for 22% to 55% of the dose. Less than 1% of the dose is excreted in the urine as N1-desalkyl-flurazepam.

This pharmacokinetic profile may be responsible for the clinical observation that flurazepam is increasingly effective on the second or third night of consecutive use and that for 1 or 2 nights after the drug is discontinued both sleep latency and total wake time may still be decreased.

Geriatric Pharmacokinetics: The single dose pharmacokinetics of flurazepam were studied in 12 healthy geriatric subjects (aged 61 to 85 years). The mean elimination half- life of desalkyl-flurazepam was longer in elderly male subjects (160 hours) compared with younger male subjects (74 hours), while mean elimination half-life was similar in geriatric female subjects (120 hours) and younger female subjects (90 hours). After multiple dosing, mean steady-state plasma levels of desalkyl-flurazepam were higher in elderly male subjects (81 ng/ml) compared with younger male subjects (53 ng/ml), while values were similar between elderly female subjects (85 ng/ml) and younger female subjects (86 ng/ml). The mean washout half-life of desalkyl-flurazepam was longer in elderly male and female subjects (126 and 158 hours, respectively) compared with younger male and female subjects (111 and 113 hours, respectively).1

REFERENCE:

1. Greenblatt DJ, Divoll M, Harmatz JS, MacLauglin DS, Shader RI: Kinetics and clinical effects of flurazepam in young and elderly noninsomniacs. Clin Pharmacol Ther 30:475-486, 1981.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

MEDICATION GUIDE

Dalmane (flurazepam) ®
(DAL-main) Capsules, 15 mg and 30 mg

is a Sedative-Hypnotic indicated for Insomnia

Generic name: flurazepam (flew-raz-e-pam) hydrochloride capsules

Read this Medication Guide carefully before you start taking your medicine and each time you get more, since there may be new information. It does not contain all the information about your medicine that you may need to know, so please ask your doctor, nurse or pharmacist if you have any questions.

IMPORTANT

YOUR DOCTOR HAS PRESCRIBED THIS DRUG FOR YOUR USE ONLY. DO NOT LET ANYONE ELSE USE IT. KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN AND PETS. If a child puts a Dalmane® (flurazepam) capsule in his or her mouth or swallows it, call your local Poison Control Center or go immediately to the nearest emergency room.

What is the most important information I should know about sedative-hypnotic drugs?

After taking a sedative-hypnotic drug, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medications that make you sleepy with a sedative-hypnotic drug.

Reported activities include:

  • driving a car ("sleep-driving")
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking

Important:

  1. Take a sedative-hypnotic drug exactly as prescribed:
    • Do not take more sedative-hypnotic drugs than prescribed.
    • Take the sedative-hypnotic drug right before you get in bed, not sooner.
  2. Do not take a sedative-hypnotic drug if you:
    • drink alcohol
    • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take a sedative-hypnotic drug with your other medicines
    • cannot get a full night sleep
  3. Call your doctor right away if you find out that you have done any of the above activities after taking a sedative-hypnotic drug.

What is Dalmane® (flurazepam) ?

Dalmane® (flurazepam) is a sedative-hypnotic agent used to treat insomnia (difficulty falling asleep and staying asleep).

Who should not take Dalmane® (flurazepam) ?

Do not use Dalmane® (flurazepam) if you are:

  • allergic to anything in Dalmane® (flurazepam) . (Being allergic may include having a rash, itching, swelling or breathing difficulties.) See the end of this Medication Guide for a complete list of ingredients in Dalmane® (flurazepam) . In rare cases patient have had additional symptoms such as shortness of breath, throat closing, or nausea and vomiting that suggest an allergic reaction. Some patients have required medical therapy in the emergency department as these rare complications could be fatal. Patients who experience these symptoms should seek medical attention and discontinue taking the sedative-hypnotic drug.
  • pregnant or intending to become pregnant. If a woman becomes pregnant while taking Dalmane® (flurazepam) , she should discontinue use immediately.
  • under 15 years of age. Dalmane® (flurazepam) has not been studied in children.

How should I take Dalmane® (flurazepam) ?

Dalmane® (flurazepam) comes as a capsule to take by mouth. You should take Dalmane® (flurazepam) , or other sedative-hypnotic medications, exactly as directed by your doctor. It usually is taken right before you get in bed, not sooner. If you forget to take Dalmane® (flurazepam) at bedtime, you are unable to fall asleep, and you will still be able to stay in bed for a full night's sleep, you may take Dalmane® (flurazepam) at that time. Do not take a double dose of Dalmane® (flurazepam) to make up for a missed dose.

The smallest possible effective dose is suggested for elderly patients due to the risk of the development of oversedation, dizziness, confusion and/or loss of coordination.

Sleep problems are often temporary, requiring treatment for a very short time. You should not use Dalmane® (flurazepam) , or any other sedative-hypnotic medications, for long periods of time without talking to your doctor about the risks and benefits of prolonged use.

In the case of a suspected overdose, you should contact your local poison control center immediately.

What should I avoid while taking Dalmane® (flurazepam) ?

Do not drink alcohol or take other medications that depress the central nervous system.

While taking Dalmane® (flurazepam) , do not engage in any hazardous occupations requiring complete mental alertness such as operating machinery or driving a car.

What are the possible or reasonably likely side effects of Dalmane® (flurazepam) ?

Dizziness, drowsiness, light-headedness, staggering, loss of coordination and falling have occurred, particularly in elderly or debilitated persons. Severe sedation, lethargy, disorientation and coma, probably indicative of drug intolerance or overdosage, have been reported. Also reported are headache, heartburn, upset stomach, nausea, vomiting, diarrhea, constipation, nervousness, talking more than usual, anxiety, irritability, weakness, pounding heartbeat, chest pain, body and joint pains and difficulty urinating.

General information about the safe and effective use of Dalmane® (flurazepam)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns about taking this, or any sedative-hypnotic medication, please ask your doctor. For detailed information regarding Dalmane® (flurazepam) please consult the physician's package insert. Do not use for conditions for which this medication was not prescribed. Do not give this medication to others.

What are the ingredients of Dalmane (flurazepam) ® Capsules?

Active Ingredient: flurazepam hydrochloride (15 mg or 30 mg)
Inactive Ingredients
: Each 15 mg capsule also contains cornstarch, lactose, magnesium stearate and talc; gelatin capsule shells contain D&C Red No. 28, FD&C Red No. 40, FD&C Yellow No. 6 and D&C Yellow No. 10. Each 30 mg capsule also contains cornstarch, lactose and magnesium stearate; gelatin capsule shells contain FD&C Blue No. 1, FD&C Yellow No. 6, D&C Yellow No. 10 and either FD&C Red No. 3 or FD&C Red No. 40.

How should I store Dalmane® (flurazepam) Capsules?

  • Store Dalmane® (flurazepam) Capsules at 25°C (77°F); excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].
  • KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN. If a child accidentally takes Dalmane® (flurazepam) , call your local Poison Control Center or go immediately to the nearest emergency room.

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by: Valeant Pharmaceuticals North America Aliso Viejo, CA 92625 U.S.A. Rev. Date: 3/09


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

FLURAZEPAM - ORAL

 

(flur-AZ-e-pam)

 

COMMON BRAND NAME(S): Dalmane

 

USES: This medication is used to treat sleep problems (insomnia). It may help you fall asleep faster, stay asleep longer, and lessen how often you wake up during the night, so you can get a better night's rest. Flurazepam belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.

Use of this medication is usually limited to treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking flurazepam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually just before you get into bed. The dosage is based on your medical condition, age, and response to treatment.

Although unlikely, this drug can infrequently cause temporary short-term memory loss. To lessen the chance of this, do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea, vomiting, flushing, stomach cramps, nervousness, shakiness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition persists after 7 to 10 days, or if it worsens.

You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1 or 2 nights. If this effect continues, contact your doctor.

Consumer Overview Side Effect

SIDE EFFECTS: Dizziness or difficulty with coordination may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly. To reduce the risk of dizziness or falling, get up slowly when rising from a sitting or lying position.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking flurazepam.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Dalmane (flurazepam) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking flurazepam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), mental/mood problems (such as depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol/other substances, personal or family history of sleepwalking, a certain muscle disease (myasthenia gravis).

Since this drug makes you drowsy, do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling.

Flurazepam must not be used during pregnancy. It may harm an unborn baby. If you are a woman of childbearing age, use a reliable form of birth control while taking this drug. If you are planning pregnancy, do not take this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication may pass into breast milk and have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: sodium oxybate.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, other medicine for sleep or anxiety (such as alprazolam, diazepam, lorazepam), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include slowed breathing or a deep sleep from which you cannot be awakened.

 

NOTES: Do not share this medication with others. It is against the law.

As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.

 

MISSED DOSE: If you miss a dose, do not take it unless you have time to sleep for 7 to 8 hours afterward. (See also How to Use section.)

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Dalmane

Generic Name: flurazepam (Pronunciation: flure AZ e pam)

  • What is flurazepam (Dalmane)?
  • What are the possible side effects of flurazepam (Dalmane)?
  • What is the most important information I should know about flurazepam (Dalmane)?
  • What should I discuss with my healthcare provider before taking flurazepam (Dalmane)?
  • How should I take flurazepam (Dalmane)?
  • What happens if I miss a dose (Dalmane)?
  • What happens if I overdose (Dalmane)?
  • What should I avoid while taking flurazepam (Dalmane)?
  • What other drugs will affect flurazepam (Dalmane)?
  • Where can I get more information?

What is flurazepam (Dalmane)?

Flurazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) similar to Valium. Flurazepam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Flurazepam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Flurazepam may also be used for purposes not listed in this medication guide.

Dalmane 30 mg

red/yellow, imprinted with DALMANE 30 ROCHE

What are the possible side effects of flurazepam (Dalmane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • staggering walk, loss of balance or coordination;
  • agitation, confusion, slurred speech, hallucinations, feelings of extreme happiness or sadness;
  • chest pain, fast or pounding heartbeats, feeling short of breath;
  • fever, chills, body aches, flu symptoms;
  • problems with urination;
  • vision problems, burning in your eyes; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness, weakness, daytime drowsiness (or during hours when you are not normally sleeping);
  • headache, blurred vision, depressed mood;
  • stomach pain, heartburn, upset stomach, nausea, vomiting, diarrhea, constipation;
  • feeling nervous, excited, or irritable;
  • increased sweating;
  • flushing (warmth, redness, or tingly feeling);
  • mild itching or rash; or
  • dry mouth, unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Dalmane (flurazepam) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about flurazepam (Dalmane)?

Flurazepam may cause a severe allergic reaction. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Take flurazepam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medication have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking flurazepam and talk with your doctor about another treatment for your sleep disorder.

This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use flurazepam if you are pregnant.

Before taking flurazepam, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, myasthenia gravis, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Flurazepam may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Contact your doctor if your insomnia does not improve after taking flurazepam for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions.

Side Effects Centers
  • Dalmane

Patient Detailed How Take

What should I discuss with my healthcare provider before taking flurazepam (Dalmane)?

Some people using this medication have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking flurazepam and talk with your doctor.

You should not use this medication if you are allergic to flurazepam or similar medications, such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or triazolam (Halcion).

To make sure flurazepam is safe for you, tell your doctor if you have any of these conditions:

  • asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
  • glaucoma;
  • kidney or liver disease;
  • myasthenia gravis; or
  • a history of depression, drug or alcohol addiction, or suicidal thoughts or actions.

Flurazepam may be habit forming. Never share flurazepam with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Do not use flurazepam if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Flurazepam can harm an unborn baby or cause birth defects. Use an effective form of birth control while you are using this medication.

Flurazepam may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of flurazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking flurazepam.

How should I take flurazepam (Dalmane)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take flurazepam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Call your doctor if your insomnia does not improve after taking flurazepam for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions.

Do not stop using flurazepam suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using flurazepam.

Your insomnia symptoms may return when you stop using flurazepam after using it over a long period of time. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Flurazepam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers
  • Dalmane

Patient Detailed Avoid Taking

What happens if I miss a dose (Dalmane)?

Since flurazepam is taken as needed, you are not likely to be on a dosing schedule. Take flurazepam only when you have time for several hours of sleep.

What happens if I overdose (Dalmane)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of flurazepam can be fatal, especially if taken with alcohol.

Overdose symptoms may include extreme drowsiness, confusion, weak or shallow breathing, fainting, or coma.

What should I avoid while taking flurazepam (Dalmane)?

Do not drink alcohol while you are taking flurazepam. It can increase some of the side effects, and could possibly cause a fatal overdose.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect flurazepam (Dalmane)?

Cold or allergy medicine, other sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by flurazepam.

Tell your doctor about all other medicines you use, especially:

  • cimetidine (Tagamet);
  • clozapine (Clozaril, FazaClo);
  • droperidol (Inapsine);
  • fluvoxamine (Luvox);
  • nefazodone (an antidepressant); or
  • itraconazole (Sporanox) or ketoconazole (Nizoral).

This list is not complete and other drugs may interact with flurazepam. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about flurazepam.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 8.01. Revision date: 11/12/2012.

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Side Effects Centers
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