Mogadon: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MOGADON is intended to help you sleep if you have transient and short-term insomnia. Symptoms of insomnia include difficulty in falling asleep, and/or waking up often during the night or too early in the morning. Treatment with MOGADON should usually not go on for more than 7 to 10 days and should be restricted for insomnia where disturbed sleep results in impaired daytime functioning. MOGADON does not treat the underlying cause of your insomnia.

• MOGADON is also useful for the management of myoclonic seizures.

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

What it does:

‘Mogadon’ is one of several benzodiazepine sleeping pills that have generally similar properties such as a calming effect.

If you are prescribed one of these medications, you should consider both their benefits and risks. Important risks and limitations include the following:

• the longer you use the medication, the less effective it may become,
• you may become dependent on the medication,
• the medication may affect your mental alertness or memory, particularly when not taken as prescribed. (see “WARNINGS AND PRECAUTIONS”)

When it should not be used:

Do not take MOGADON (nitrazepam) if you have:

• known allergy to nitrazepam or other benzodiazepines, or to any of the ingredients MOGADON contains (see “What the nonmedicinal ingredients are”).
• severe lung or respiratory disease, including sleep apnea.
• myasthenia gravis, a chronic disease characterized by weakness of the skeletal muscles.
• a severe liver condition.

MOGADON is not to be used for insomnia in children under 18 years of age

What the medicinal ingredient is:

The medicinal ingredient in MOGADON is nitrazepam.

What the non-medicinal ingredients are:

MOGADON Tablets also contain the following non-medicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

What dosage forms it comes in:

MOGADON is available in tablets of 5 mg and 10 mg strengths for oral administration.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

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 MOGADON. For example, you may experience an increase in sleep difficulties (rebound insomnia) and/or increased daytime anxiety (rebound anxiety) for one or two days after discontinuing MOGADON.
• Your risk of going through withdrawal is higher if you are taking MOGADON for a long time or at high doses. However, symptoms can still occur if you are taking MOGADON 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, how often they happen 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 MOGADON 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

MOGADON with Opioids: Taking MOGADON 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 MOGADON

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

Falls and Fractures: Benzodiazepines like MOGADON can cause you to feel sleepy, dizzy and affect your balance. This increases your risk 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

Complex Sleep-Related Behaviours:

There have been reports of people getting out of bed while not fully awake after taking MOGADON and doing activities that they did not know they were doing. The next morning, they did not remember doing those activities. This unusual behaviour is more likely to occur when MOGADON is taken with alcohol or other drugs that can make you sleepy such as those for the treatment of depression or anxiety. The activities you may do in these situations can put you and people around you in danger. Reported activities included driving a car (“sleep-driving”), leaving the house, making and eating food, talking on the phone, etc.

Important:

1. 1. Do not take more MOGADON than prescribed.
2. 2. Do not take MOGADON if you drink alcohol.
3. 3. Talk to your doctor about all of your medicines, including over-the-counter medicines and herbal products. Your doctor will tell you if you can take MOGADON with your other medicines.
4. 4. You and people close to you should watch for the type of unusual behaviour described above. If you find out that you have done any such activities for which you have no memory you should call your doctor immediately.

Mental Alertness:

MOGADON may affect your ability to be alert. DO NOT DRIVE A CAR or operate potentially dangerous machinery until you experience how this drug will affect you.

Memory Problems:

All benzodiazepine sleeping pills can cause a special type of memory loss (amnesia); you may not recall events that occurred during some period of time, usually several hours, after taking the drug. This lapse is usually not a problem, because the person taking the sleeping pill intends to be asleep during this critical period of time. But it can be a problem if you take the medication to induce sleep while travelling, such as during an airplane flight, because you may wake up before the effect of the drug is gone.

This has been called “traveler's amnesia”. DO NOT TAKE MOGADON when a full night's sleep is not possible before you would again need to be active and functional; e.g., an overnight flight of less than 8 hours. Memory lapses may occur in such situations. Your body needs time to eliminate the medication from your system.

Dependence/Abuse:

All benzodiazepine sleeping pills can cause dependence (addiction) especially when used regularly for more than a few weeks, or at higher doses. Some people develop a need to continue taking these drugs, either at the prescribed dose or at higher doses - not only for continued therapeutic effect, but also to avoid withdrawal symptoms or to achieve non-therapeutic effects.

Individuals who depend, or have depended at any time in the past, on alcohol or other drugs may be at particular risk of becoming dependent on drugs of this class. But ALL PEOPLE ARE AT SOME RISK. Consider this matter before you take these medications beyond a few weeks.

Mental and Behavioural Changes:

A variety of abnormal thinking and behaviour changes may occur when you use benzodiazepine sleeping pills. Some of these changes include aggressiveness and extroversion which seem out of character. Other changes, although rare, can be more unusual and extreme such as confusion, strange behaviour, restlessness, illusions, hallucinations, feeling like you are not yourself, worsening insomnia and worsening depression, including suicidal thinking.

It is rarely clear whether such symptoms are caused by the medication, or by an illness that was present before the medication was used, or are simply spontaneous happenings. If you develop any unusual disturbing thoughts or behaviour while using MOGADON, discuss the matter immediately with your doctor.

Excessive Salivation:

On rare occasions in infants and young children, as well as elderly, bed-ridden patients, there may be excessive secretion of saliva and fluid in the lungs which may lead to chest infections.

Worsening of Side Effects:

DO NOT CONSUME ALCOHOL WHILE TAKING MOGADON. Some medicines may also worsen side effects that some patients experience with MOGADON (see “INTERACTIONS WITH THIS MEDICATION”).

Effects on Pregnancy:

Certain benzodiazepine sleeping pills have been linked to birth defects when taken during pregnancy. In addition, benzodiazepine sleeping pills taken during the last weeks of pregnancy have been known to sedate the baby and may also cause withdrawal symptoms after birth. DO NOT TAKE MOGADON at any time during pregnancy.

BEFORE you use MOGADON talk to your doctor or pharmacist if:

• You have a lung disease or breathing problems.
• You have liver or kidney condition.
• You have a history of depression and/or suicide thoughts or attempts.
• You have had unexpected reactions to alcohol or sedative medications in the past, such as irritability, aggression, hallucinations, etc.

• You have ever had a problem with:

  • substance use, including prescribed or illegal drugs, or
  • alcohol
• You have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness)
• You are planning to become pregnant, you are pregnant, or you become pregnant while taking this medication.
• You are breastfeeding.
• You consume alcohol.
• You are taking other medicines, including drugs you can buy without a prescription.
• You have lactose intolerance.

INTERACTIONS WITH THIS MEDICATION

Nitrazepam may produce more pronounced side effects when co-administered with alcohol, other tranquilizers or sleeping pills, sedative antihistamines, narcotic analgesics (opioids) (see Serious Warnings and Precautions box), anticonvulsants, antipsychotics (neuroleptics), anesthetics, or antidepressant agents or psychotropic medications which themselves can make you sleepy.

Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines and benzodiazepine-like agents. Examples include cimetidine or erythromycin.

Do not take MOGADON if you drink alcohol. DO NOT USE MOGADON along with other medications without first discussing this with your doctor.

PROPER USE OF THIS MEDICATION

Benzodiazepine sleeping pills are effective medications and are relatively free of serious problems when used for the short-term management of insomnia. Insomnia may last only for a short time and may respond to brief treatment. The risks and benefits of prolonged use should be discussed with your doctor.

Usual dose in Insomnia:

• MOGADON is a prescription medication intended to help you sleep. Follow your doctor's advice about how to take MOGADON, when to take it, and how long to take it.

• 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.

Adults: The usual adult dose is 5 or 10 mg before retiring.

Elderly and/or Debilitated Patients: It is recommended that in these patients therapy be initiated with 2.5 mg until individual responses are determined. Doses higher than 5 mg are usually not recommended in the elderly.

DO NOT TAKE MOGADON if it is not prescribed for you.

DO NOT TAKE MOGADON for more than 7 to 10 days without first consulting your doctor. If you still have problems sleeping after you finish your tablets, contact your doctor again.

The lowest effective dose should be used.

DO NOT INCREASE THE PRESCRIBED DOSE.

Do not take MOGADON if you drink alcohol.

Do not take MOGADON when a full night’s sleep is not possible before you would again need to be active and functional.

Do not drive a car or operate potentially dangerous machinery until you experience how MOGADON will affect you the next day.

MOGADON is not for use for insomnia in children under 18 years of age.

Overdose:

The principal manifestations of overdosage are drowsiness, confusion, reduced reflexes, increasing sedation, and coma. Effects on respiration, pulse and blood pressure are noticed with large overdoses. Patients exhibit some jitteriness and over stimulation usually when the effects of the drug begin to wear off.

Contact your doctor, regional Poison Control Centre or pharmacist immediately if you suspect you have taken an overdose or someone else accidentally takes your MOGADON. If you are unable to contact them, go to a hospital emergency department for medical help, even though you may not feel sick. Show your doctor your bottle of tablets.

Missed Dose:

If you forget to take MOGADON Tablets, do not take a double dose to make up for the forgotten individual dose. Take the next dose at the usual time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Common Side Effects:

Benzodiazepine sleeping pills may cause drowsiness, dizziness, light-headedness, and difficulty with coordination. Users must be cautious about engaging in hazardous activities requiring complete mental alertness, e.g., operating machinery or driving a motor vehicle.

DO NOT drink alcohol while using MOGADON. DO NOT USE MOGADON along with other medications without first discussing this with your doctor.

How sleepy you are the day after you use one of these sleeping pills depends on your individual response and on how quickly your body gets rid of the medication. The larger the dose, the more likely that you will experience drowsiness, etc., the next day. For this reason, it is important that you use the lowest dose possible that will still help you sleep at night. Benzodiazepines which are eliminated rapidly tend to cause less drowsiness the next day, but may cause withdrawal problems the day after use.

Elderly patients are especially susceptible to side effects.

Falls and Fractures: Excessive drowsiness in the elderly may result in falls and fractures.

Rare cases of severe allergic reactions have been reported.

Symptoms may include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking MOGADON.

Withdrawal-related side effects: See “WARNINGS AND

PRECAUTIONS, Tolerance/Withdrawal Symptoms”.

This is not a complete list of side effects. For any unexpected effects while taking MOGADON, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15°C to 30°C). Protect from light.

Keep out of reach of children.

Reporting Side Effects

MORE INFORMATION

If you want more information about MOGADON:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website (https://www.aapharma.ca/en/products) or by calling 1-877-998-9097.

Last revised: August 12, 2021