Flurazepam (patient information)

IMPORTANT WARNING

[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.

Why this medication is prescribed

Flurazepam is used to treat insomnia (difficulty falling asleep and staying asleep). Flurazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain.

How this medication should be used

Flurazepam comes as a capsule to take by mouth . It usually is taken before bedtime when needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take flurazepam exactly as directed.

Flurazepam can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor.

Flurazepam starts working slowly and continues to work for a short time after you stop taking it. It may take two or three nights before you experience the full benefit of flurazepam. You may continue to feel the effects of flurazepam for one to two nights after you stop taking the medication.

Do not stop taking flurazepam without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking flurazepam, especially after taking it regularly, you may develop withdrawal symptoms such as sadness, difficulty sleeping, seizures, shaking of a part of your body that you cannot control, stomach and muscle cramps, vomiting, and sweating.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking flurazepam:

• tell your doctor and pharmacist if you are allergic to flurazepam, any other medications, or corn.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take during your treatment with flurazepam and for several days afterward. Be sure to mention any of the following: antihistamines; medications for anxiety,depression mental illness, or seizures; ; muscle relaxants; sedatives; sleeping pills;andtranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had depression; mental illness; glaucoma; or lung, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking flurazepam, call your doctor immediately.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking flurazepam.
• you should know that this medication may make you drowsy and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night.Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while you are taking flurazepam and for several days after you stop taking the medication.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
• you should know that your mental health may change in unexpected ways while you are taking this medication. It is hard to tell if these changes are caused by flurazepam or if they are caused by physical or mental illnesses that you already have or suddenly develop. Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.

What to do if you forget a dose

Flurazepam should only be taken at bedtime. If you forget to take 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 flurazepam at that time. Do not take a double dose of flurazepam to make up for a missed dose.

Side effects

Minor side effects

Flurazepam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness or lightheadness
• loss of coordination
• headache
• heartburn
• upset stomach
• vomiting
• stomach pain
• diarrhea
• constipation
• nervousness
• talking more than usual
• weakness
• difficulty urinating

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• pounding heartbeat
• chest pain
• confusion
• rash

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• confusion
• coma

Other information

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Dalmane®