FLURAZEPAM

COMMON BRAND NAME(S): Dalmane

GENERIC NAME(S): FLURAZEPAM HCL

 

Description: Flurazepam is a long-acting benzodiazepine that works by depressing the central nervous system (brain), causing drowsiness to aid in falling asleep.

Onset: Hypnotic: 15-20 min.

Duration: 7-8 hr.

Pharmacokinetics:

Absorption: Readily absorbed from the GI tract. Time to peak plasma concentration: Approx 30-60 min.

Distribution: Crosses the placenta. Volume of distribution: 3.4 L/kg. Plasma protein binding: Approx 97%.

Metabolism: Undergoes hepatic metabolism to N-desalkylflurazepam (active) and N-hydroxyethylflurazepam.

Excretion: Via urine (mainly as conjugated metabolites). Elimination half-life: 2.3 hr (parent drug).

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.

 

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.

 

This drug is a prescription only drug.

 

How to use flurazepam:

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.

Not available.

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.

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.

 

Interactions

 

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.

If overdose is suspected, contact a poison control center or emergency room immediately. 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.

 

Brands

 

Also marketed as

Dalmane [ ICN ]

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