Silenor: Uses, Side Effects and Dosage

What SILENOR is used for:

SILENOR is used to treat adults who have trouble staying asleep.

How SILENOR works:

SILENOR belongs to a group of medicines known as tricyclic antidepressants. It is not known exactly how SILENOR works, but it is thought to reduce the release of a chemical called histamine in your body. Reducing this chemical helps to promote and maintain sleep.

The ingredients in SILENOR are:

Medicinal ingredient: doxepin hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, D&C yellow no. 10 aluminum lake (6 mg tablets only), FD&C blue no. 1 aluminum lake, magnesium stearate and microcrystalline cellulose

SILENOR comes in the following dosage forms:

Tablets: 3 mg and 6 mg

Do not use SILENOR if:

• you are allergic to doxepin hydrochloride, other dibenzoxepine compounds, or to any of the other ingredients in SILENOR (see The ingredients in SILENOR are:)
• you have an eye problem called narrow angle glaucoma that is not being treated
• you have difficulty urinating
• you take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare professional if you are not sure if your medicine is an MAOI.

Talk to your healthcare professional before taking this medicine if you have any of these conditions.

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

• suffer from depression or have a history of depression and/or suicidal thoughts
• have breathing problems at night (sleep apnea)
• have a liver disease

• have a history of drug or alcohol abuse or addiction

• are pregnant, plan to become pregnant or you become pregnant while taking this medication

• are breastfeeding or plan to breastfeed. SILENOR may pass into your milk and may harm your baby. You should not breastfeed while taking SILENOR.

Other warnings you should know about:

Sleep problems can be a symptom of many physical and/or psychiatric disorders. Your healthcare professional will evaluate your medical history before starting treatment with SILENOR. If your sleep problems get worse or do not get better within 7 to 10 days, talk to your healthcare professional. This may mean that there is another condition causing your sleep problem.

Complex Sleep Behaviours: SILENOR can cause dangerous sleeping-related behaviours such as getting out of bed while not fully awake and doing activities that you do not know you are doing. You may not remember doing these activities when you wake up. These unusual behaviours may occur whether or not you drink alcohol but is more likely to occur with alcohol. These behaviours may also occur if you take other medicines that can make you sleepy, such as medicines used to treat depression or anxiety. 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, having sex and talking on the phone. These behaviours can cause serious injuries, including death.

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

Depression or Suicide: If you have thoughts of harming or killing yourself at any time, talk to a healthcare professional or go to a hospital right away. You may find it helpful to tell a relative or close friend that you are depressed or have other mental illnesses. Ask them to read this leaflet. You might ask them to tell you if they:

• think your depression or mental illness is getting worse, or
• are worried about changes in your behaviour.

Driving and Using Machines: SILENOR can affect your ability to drive and operate machinery. Do not drive or operate machinery until you know how SILENOR affects you.

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

Serious drug interactions

The following may also interact with SILENOR:

• alcohol. Do not use SILENOR if you drink alcohol.
• other hypnotics or sedatives that are used to help with sleeping
• certain allergy medicines (antihistamines)
• other medicines that can make you sleepy or affect your breathing (narcotic analgesics)
• medicines used to control or prevent convulsions (anticonvulsants)
• mood altering drugs, which themselves can make you sleepy (antipsychotics, antidepressants and other psychotropic medications)
• cimetidine (an anti-acid medication)
• medicines that block, or are a substrate of an enzyme called “CYP2D6”, such as quinidine and selective serotonin reuptake inhibitors (SSRIs)
• medicines that mimic the effects of the sympathetic nervous system (sympathomimetics), such as ephedrine, phenylephrine and phenylpropanolamine

How to take SILENOR:

• Take SILENOR exactly as your healthcare professional tells you to take it.
• Take SILENOR within 30 minutes of bedtime. After taking SILENOR, you should only do activities to get ready for bed.
• Only take SILENOR if you are able to get a full night of sleep (7 to 8 hours).
• To minimize any next day side effects, do NOT take SILENOR within 3 hours of a meal.
• Remember: This medication is for you only. Never give it to others. It may harm them even if their symptoms are the same as yours.

Usual dose:

Adults: The recommended dose is 6 mg once daily. Depending on your response, your healthcare professional may decrease your daily dose to 3 mg.

Elderly (65 years of age and older): The recommended starting dose is 3 mg once daily. Depending on your response, your healthcare professional may increase your daily dose to 6 mg.

The maximum daily dose is 6 mg.

Overdose:

If you think you, or a person you are caring for, have taken too much SILENOR, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

• Do NOT take SILENOR if you take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare professional if you are not sure if your medicine is an MAOI.

Missed dose:

If you forget to take your dose at bedtime, wait and take your next dose at your regular time the next night. Do NOT take 2 doses at the same time to make up for a missed dose.

Possible side effects from using SILENOR:

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

Side effects may include:

• sleepiness or drowsiness
• nausea or vomiting
• headache
• dry mouth
• stomach pain
• upper respiratory tract infection
• a cold
• diarrhea
• tooth infection
• falls or joint sprains
• joint stiffness or back pain
• tingling or prickling
• altered sense of taste
• abnormal dreams
• anxiety

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature between 15°C and 30°C and protect from light.

Keep out of reach and sight of children.

If you want more information about SILENOR:

• 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://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.