September 16, 2014
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Sublinox

(zolpidem)

DIN (Drug Identification Number)

02370433 SUBLINOX 10MG ORALLY DISINTEGRATING TABLET

What side effects are possible with Sublinox?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • diarrhea
  • dizziness
  • drowsiness
  • dry mouth
  • fatigue
  • flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
  • headache
  • heartburn
  • hiccups
  • loss of appetite
  • nausea
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • aggressiveness
  • agitation
  • behaviour changes (e.g., mood or mental changes, irritability, anger, aggression)
  • clumsiness or unsteadiness
  • confusion (more common for seniors)
  • daytime anxiety or restlessness
  • drowsiness (severe)
  • "drugged" feeling
  • fast, irregular, pounding heartbeat
  • hallucinations (seeing or hearing things that aren't there)
  • joint pain
  • memory problems
  • muscle aches
  • signs of breathing problems (e.g., shortness of breath; troubled breathing; wheezing or tightness in chest; fast, or irregular breathing)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of a urinary tract infection such as difficult or painful urination, or blood in the urine
  • skin rash
  • sleepwalking
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • chest pain
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Sublinox?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

January 3, 2014

Health Canada has issued new information concerning the use of Sublinox (zolpidem). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

A previous advisory on Sublinox was issued on December 5, 2011. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Allergic reaction: In rare cases, some people may develop a serious allergic reaction to medications like zolpidem involving swelling of the tongue, glottis, or larynx. Some people have had shortness of breath, nausea, vomiting, or throat closing.

Other signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If you experience any of these symptoms after taking zolpidem, seek immediate medical attention.

Behaviour changes: This medication may cause agitated or aggressive behaviour. If you experience these symptoms or any other behaviour change while taking this medication, contact your doctor immediately.

Family members or caregivers of people who are taking this medication should contact the person's doctor immediately if they notice unusual behaviour changes.

Breathing problems: Zolpidem can suppress breathing. If you are at risk for breathing difficulties, such as asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Confusion: This medication affects mental efficiency (e.g., concentration, attention, and vigilance). The risk of confusion is greater for seniors and those with brain damage.

Dependence and withdrawal: Physical dependence, psychological dependence, and abuse have occurred with the use of zolpidem. If you have a history of past or current substance use problems you may be at greater risk of developing abuse or addiction while taking this medication.

Withdrawal symptoms have been observed after stopping the medication suddenly (after having taken it regularly over a period of time). These symptoms include:

  • abdominal cramps
  • anxiety
  • diarrhea
  • fatigue
  • flushing
  • headache
  • irritability
  • memory impairment
  • nausea
  • nervousness
  • restlessness
  • seizures
  • sleep problems such as rebound insomnia
  • sweating
  • tension
  • tremors
  • vomiting

If you have been taking this medication for longer than 10 days, discuss with your doctor the best way to stop zolpidem.

Depression: Medications used for sleep disturbances have been known to cause mood swings and symptoms of depression. Zolpidem may worsen symptoms of depression, including thoughts of suicide or wanting to harm others.

If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Drowsiness/reduced alertness: Zolpidem can cause excessive daytime drowsiness and decreased mental alertness. Do not drive, operate machinery, or perform other dangerous tasks until you know how this medication affects you.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Memory disturbance: Although rare, amnesia of varying severity has been reported following normal doses of medications like zolpidem. If you experience any memory problems while taking this medication, contact your doctor.

Performing activities while not fully awake: People taking zolpidem may perform activities such as sleepwalking, driving, preparing and eating food, and making phone calls while not fully awake and unaware of their actions. The next morning, they may not remember what happened. This may be more likely to occur if you use alcohol or other sedative medications. If you discover this has happened to you, contact your doctor immediately.

Family members or caregivers of people who are taking this medication should contact the person's doctor immediately if they notice any of these unusual behaviours.

Rebound insomnia: As with other medications used to aid in sleeping, you may experience a temporary return of your sleeping difficulties when zolpidem is stopped.

Pregnancy: The use of zolpidem during pregnancy has not been studied. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking zolpidem, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of zolpidem have not been established for use by children and adolescents less than 18 years of age.

Seniors: People over 65 years of age are more likely to experience dose-related side effects of zolpidem, such as drowsiness, dizziness, or impaired coordination. Zolpidem is not recommended for use in seniors.

What other drugs could interact with Sublinox?

There may be an interaction between zolpidem and any of the following:

  • alcohol
  • anti-anxiety medications (e.g., clonazepam, lorazepam)
  • anticonvulsants (medications used to prevent seizures; e.g., phenytoin, valproic acid, carbamazepine)
  • antihistamines that cause drowsiness (e.g., chlorpheniramine, diphenhydramine)
  • antipsychotic medications (e.g., olanzapine, quetiapine) or mood-altering medications (e.g., lithium)
  • "azole" antifungals (e.g., ketoconazole, itraconazole, voriconazole)
  • cimetidine
  • clarithromycin
  • conivaptan
  • dimenhydrinate
  • droperidol
  • methotrimeprazine
  • narcotic or opioid medications (e.g., codeine, fentanyl, morphine, oxycodone)
  • nefazodone
  • nicardipine
  • protease inhibitors (e.g., darunavir, ritonavir, saquinavir)
  • rifampicin
  • rifampin
  • sedatives or tranquilizers (e.g., diazepam, zopiclone)
  • St. John's wort
  • telithromycin
  • tricyclic antidepressants (e.g., amitriptyline, desipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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