Flurazepam: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is FLURAZEPAM used for?

FLURAZEPAM is used in adults to treat short-term insomnia. This is a sleep disorder that makes it hard to fall asleep, hard to stay asleep, or causes you to wake up too early. FLURAZEPAM should be only be used when the effects of insomnia affect your daytime activities.

If you are 65 years or older, talk to your doctor before starting FLURAZEPAM. FLURAZEPAM may not be an effective treatment for you and you may be more sensitive to experiencing side effects.

How does FLURAZEPAM work?

FLURAZEPAM belongs to a group of medicines called benzodiazepine sleeping pills. It works to decrease the time required to fall asleep and the number of times you wake up during sleep.

What are the ingredients in FLURAZEPAM?

Medicinal ingredient: Flurazepam hydrochloride.

Non-medicinal ingredients: D&C yellow #10, FD&C red #40 (15 mg), FD&C yellow #40 (30 mg), FD&C yellow #6, gelatin, lactose, silicon dioxide, sodium lauryl sulfate, starch, stearic acid, and titanium dioxide.

FLURAZEPAM comes in the following dosage forms:

Capsules: 15 mg and 30 mg of flurazepam hydrochloride.

Do not use FLURAZEPAM if:

• you are allergic to benzodiazepines, such as flurazepam hydrochloride, or to any other ingredients in FLURAZEPAM.
• you have severe lung or breathing problems (e.g., sleep apnea).
• you have myasthenia gravis (a condition characterized by weakness of your muscles).
• you have severe liver problems.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FLURAZEPAM. Talk about any health conditions or problems you may have, including if you:

• have ever had a problem with:

  • substance use, including prescribed or illegal drugs, or

  • alcohol.

• have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness)
• have lung or breathing problems.
• have liver problems.
• have kidney problems.
• have signs of depression or a history of depression.
• have a history of suicide thoughts or attempts.
• have a history of violent behaviours.
• have had an unexpected reaction to sedative medications in the past (e.g., such as irritability, aggression, hallucinations, etc.).
• are pregnant or planning to become pregnant, FLURAZEPAM is not recommended for use during pregnancy.
• are breast-feeding or planning to breast-feed. FLURAZEPAM is not recommended for use during breast-feeding.
• drink or plan to drink alcohol. Do not drink alcohol while you take FLURAZEPAM.
• are taking other medications, including over-the-counter medications, opioids, sedatives, medications that affect your central nervous system (CNS depressants).
• are taking illicit drugs.
• are unable to digest lactose, a milk sugar (lactose intolerance). Lactose is a component of FLURAZEPAM.
• are 65 years of age or older.
• have a condition that causes weakness or frailty.
• have impaired thinking, confusion or any other type of brain damage.

Other warnings you should know about:

Sleep-Related Behaviours:

Treatment with FLURAZEPAM can cause potentially dangerous sleeping-related behaviours such as getting out of bed while not fully awake after taking FLURAZEPAM and doing activities that you do not know you are doing. If this happens, you may not remember doing these activities when you wake up. These unusual behaviours are more likely to occur when FLURAZEPAM is taken with alcohol or other drugs that can make you sleepy (e.g., medicines used to treat depression or anxiety). If you drink alcohol, do not take FLURAZEPAM The activities you may do in these situations can put you and people around you in danger. This can include driving a car (“sleep-driving”), leaving the house, making and eating food, and talking on the phone.

You and people close to you should watch unusual types of behavior when you are asleep. If you find out that you have done any such activities for which you have no memory, you should call your healthcare professional immediately.

Memory Problems: In rare cases, FLURAZEPAM can cause a type of memory loss known as amnesia. This is characterized by having difficulty recalling events that recently occurred, usually several hours after taking the medication. If you intend to take FLURAZEPAM before sleeping, this is usually not a problem. However, if you take FLURAZEPAM to induce sleep while travelling, such as during an airplane flight, you may wake up to memory lapse caused by the drug. This has been called “traveller's amnesia” and can be a problem. Therefore, DO NOT TAKE FLURAZEPAM when a full night's sleep is not possible before you need to be active and functional (e.g., an overnight flight of less than 8 hours). Your body needs time to eliminate the medication from your system.

Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop FLURAZEPAM.

Your risk of going through withdrawal is higher if you are taking FLURAZEPAM for a long time or at high doses. However, symptoms can still occur if you are taking FLURAZEPAM as directed for a short period of time or slowly reducing the dose.

The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).

Tell your doctor right away if you experience any symptoms of withdrawal after changing or stopping your treatment.

Severe symptoms of withdrawal include:

• feeling like you cannot move or respond (catatonia)
• severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens)
• feeling depressed
• feeling disconnected from reality (dissociation)
• seeing or hearing things that are not there (hallucinations)
• overactive behaviour and thoughts (mania)
• believing in things that are not true (psychosis)
• convulsions (seizures), including some that do not stop
• thoughts or actions of suicide

For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).

To reduce your chances of going through withdrawal:

• always contact your doctor before stopping or reducing your dose of FLURAZEPAM or changing medications
• always follow your doctor’s instructions on how to reduce your dose carefully and safely
• tell your doctor right away if you experience any unusual symptoms after changing or stopping your treatment

FLURAZEPAM with Opioids: Taking FLURAZEPAM with opioid medicines can cause severe drowsiness and breathing problems.

Tell your doctor if you:

• are taking opioid medicines
• are prescribed an opioid medicine after you start taking FLURAZEPAM

Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and FLURAZEPAM affects you.

Falls and Fractures: Benzodiazepines like FLURAZEPAM can cause you to feel sleepy, dizzy and affect your balance. This increases your risks of falling, which can cause fractures or other fall related-injuries, especially if you:

• take other sedatives,
• consume alcohol,
• are elderly or
• have a condition that causes weakness or frailty.

Mental and Behavioural Changes: A variety of abnormal thinking and behaviour changes may occur when you take benzodiazepine sleeping pills, including FLURAZEPAM. Some of these changes include aggressiveness and extroversion that seem out of character confusion, strange behaviour, anxiety, restlessness, hallucinations, feeling like you are not yourself, worsening insomnia or depression, and suicidal thoughts. It is hard to determine if these symptoms are caused by the medication, by an illness that was present before the medication was used, or are natural. If you develop any unusual thoughts or behaviour while using FLURAZEPAM, tell your healthcare professional right away.

Worsening of Side Effects:

DO NOT CONSUME ALCOHOL WHILE TAKING FLURAZEPAM. Your symptoms of insomnia may worsen with FLURAZEPAM, especially if you are also taking other similar medications.

Severe Allergic Reaction: In rare cases, FLURAZEPAM has caused severe allergic reactions including anaphylaxis, which can be life-threatening. The symptoms of a severe allergic reaction include angioedema of the tongue or throat (swelling of tissues under the skin), shortness of breath, throat closing, nausea or vomiting. Angioedema can lead to a blocked airway and can be life-threatening. If you develop angioedema or you notice signs of a severe allergic reaction after taking FLURAZEPAM, you should stop taking FLURAZEPAM and tell your healthcare professional right away.

Elderly: If you are 65 years of age or older and take benzodiazepines including FLURAZEPAM, you are at a higher risk of falls and fractures.

Pregnancy: Benzodiazepines, such as FLURAZEPAM, may cause a risk to your unborn baby (e.g., birth defects) if you are pregnant. This typically occurs more often during the first trimester or last weeks of pregnancy. If you are able to get pregnant, want to be or think you are pregnant, there are specific risks you should discuss with your healthcare professional.

Monitoring and Testing: If you are prescribed FLURAZEPAM, your healthcare professional may conduct blood tests to assess your health. Your healthcare professional will interpret your results and may adjust or stop your dose of FLURAZEPAM.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FLURAZEPAM:

• alcohol. Do not take FLURAZEPAM if you drink alcohol,
• sedative antihistamines that are used to treat allergies but make you drowsy or sleepy after you take them,
• anticonvulsants used to prevent or treat seizures,
• antidepressants used to treat depression,
• medicines used to alter your mental state or mood,
• other benzodiazepines typically used to treat anxiety, insomnia, and seizures (e.g., oxazepam),
• medicines that inhibit certain liver enzymes, particularly cytochrome P450 (e.g., cimetidine and erythromycin). If you are unsure, talk to your healthcare professional.

DO NOT USE FLURAZEPAM along with other medications without first discussing this with your doctor.

How to take FLURAZEPAM:

• Take FLURAZEPAM just before going to bed. Do not take FLURAZEPAM if a full night’s sleep is not possible before you need to become active and functional again.
• Do not consume any alcohol while taking FLURAZEPAM.

Usual dose:

• Take FLURAZEPAM exactly as prescribed by your healthcare professional. They will determine the right dose and the length of FLURAZEPAM for you. This will depend on your age, current health, and if you take certain other medications.
• Your healthcare professional will also monitor how FLURAZEPAM is working for you, especially at the start of your treatment. They may adjust your dose to ensure that the lowest effective dose is prescribed.
• Your doctor will slowly decrease your dose and will tell you when to stop taking the medicine. Always follow your doctor’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms. However, if you notice any signs or symptoms of withdrawal, tell your healthcare professional right away.

Overdose:

Symptoms of an overdose with FLURAZEPAM include drowsiness, sleepiness, confusion and coma.

Missed Dose:

If you forget or miss a dose of FLURAZEPAM, do not take the missed dose. Instead, take the next scheduled dose at the usual time. Do not try to make up for the missed dose by taking a double dose.

What are possible side effects from using FLURAZEPAM?

These are not all the possible side effects you may have when taking FLURAZEPAM. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of FLURAZEPAM may include:

Very common (may affect more than 1 in 10 people):

• drowsiness,
• dizziness,
• light-headedness,
• difficulty with coordination.

Common (may affect up to 1 in 10 people):

• lethargy,
• disorientation (inability to know correct time, place or person),
• apprehension (worry about something or about what might happen),
• nervousness,
• heartburn,
• upset stomach,
• nausea,
• constipation,
• stomach pain,
• weakness,
• chest pains,
• urinary and genital problems,
• palpitations (heartbeats that become more noticeable).

Rare (may affect up to 1 in 10,000 people):

• flushing (redness of skin),
• blurred vision,
• fainting,
• itchiness,
• skin rash,
• dry mouth,
• bitter taste,
• excessive salivation,
• anorexia (a weight disorder characterized by low weight).

Unknown:

• falls and fractures.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store FLURAZEPAM capsules at 15°C to 25°C. Keep in a tightly closed, light-resistant container.

Keep out of reach and sight of children.

If you want more information about FLURAZEPAM:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.aapharma.ca/en/, or by calling 1-877-998-9097.

Last Revised: October 13, 2021