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 Silenor (Doxepin). If you are concerned about side effects, discuss the risks and benefits of Silenor (Doxepin) with your doctor.

The following side effects have been reported by at least 1% of people taking Silenor (Doxepin). 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.

• dizziness
• drowsiness
• Dry Mouth
• headache
• nausea
• tiredness

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

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

• anxiety
• confusion
• nervousness or restlessness
• sleepwalking or doing other activities while asleep (e.g., eating, driving)
• thoughts of death or suicide
• vomiting

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

• symptoms of a Anaphylaxis (severe allergic reaction) (e.g., swelling of face and tongue, difficulty breathing, Hives)

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 Silenor (Doxepin).

3mg
Each blue, oval tablet debossed with "3" on one side and "SP" on the other contains Silenor (Doxepin) 3 mg. Nonmedicinal ingredients: microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, D&C Lake Yellow, and FD&C Lake Blue.

6 mg
Each green, oval tablet debossed with "6" on one side and "SP" on the other contains Silenor (Doxepin) 6 mg. Nonmedicinal ingredients: microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, D&C Lake Yellow, and FD&C Lake Blue.

Silenor (Doxepin) should not be taken by anyone who:

• is allergic to Silenor (Doxepin) or to any of the ingredients of the medication
• is allergic to any other dibenzoxepin compounds
• has untreated narrow-angle Glaucoma
• has taken a MAO inhibitor (e.g., Phenelzine, Tranylcypromine) within the last 14 days
• has severe urinary retention (unable to urinate)

There may be an interaction between Silenor (Doxepin) and any of the following:

• Abiraterone
• acetylsalicylic acid (Asa)
• aclidinium
• alcohol
• alpha/beta agonists (e.g., Epinephrine, norepinephrine)
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• asunaprevir
• atropine
• azelastine
• "azole" antifungals (e.g., fluconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., Phenobarbital)
• benzodiazepines (e.g., Diazepam, Lorazepam)
• beta-2 agonists (e.g., salmeterol, formoterol, fenoterol, terbutaline)
• Bromocriptine
• Benztropine
• botulinum toxin
• brimonidine
• Buprenorphine
• Bupropion
• cannabis
• Celecoxib
• chloral hydrate
• chloroquine
• cholinesterase inhibitors (e.g., Donepezil, Galantamine, Rivastigmine)
• Cimetidine
• Cinacalcet
• Clonidine
• Decongestant Nasal sprays (e.g., oxymetazoline, phenylephrine, naphazoline)
• Darifenacin
• Degarelix
• Desmopressin
• dexmethylphenidate
• Dextromethorphan
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• Eluxadoline
• ergot alkaloids (e.g., ergotamine, Dihydroergotamine)
• Flavoxate
• Flecainide
• Glucagon
• glycopyrronium
• glycopyrrolate
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• ipratropium
• levodopa
• lithium
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• methylene blue
• Methylphenidate
• mifepristone
• Metoclopramide
• Mirabegron
• Mirtazapine
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, Selegiline, tranylcypromine)
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Nitroglycerin
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., celecoxib, Diclofenac, Ibuprofen, Naproxen)
• Olopatadine
• Oxybutynin
• potassium chloride
• procainamide
• Propafenone
• protein kinase inhibitors (e.g., imatinib, Lapatinib, Nilotinib, Pazopanib, Sunitinib)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Ofloxacin, )
• Ropinirole
• Rotigotine
• St. John's wort
• Safinamide
• scopolamine
• seizure medications (e.g., Carbamazepine, Clobazam, , Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• sodium oxybate
• sodium phosphates
• Sotalol
• sulfonylureas (e.g., Gliclazide, Glyburide, Tolbutamide)
• suvorexant
• terbinafine
• Tetrabenazine
• thalidomide
• Thyroid replacements (e.g., desiccated thyroid, Levothyroxine)
• Ticlopidine
• tiotropium
• Tolterodine
• Tramadol
• tricyclic antidepressants (e.g., Clomipramine, Desipramine, Imipramine)
• "triptan" medications (e.g., Sumatriptan, Almotriptan)
• Tryptophan
• umeclidinium
• Warfarin
• Yohimbine
• Zolpidem
• Zopiclone

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 Silenor (Doxepin). 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.

Before you begin using Silenor (Doxepin), 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 Silenor (Doxepin).

Behaviour changes: Silenor (Doxepin) may worsen symptoms of depression, including thoughts of suicide or wanting to harm others. It may also cause agitated or aggressive behaviour. If you experience these symptoms or any other behaviour change while taking Silenor (Doxepin), contact your doctor immediately.

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

Drowsiness/reduced alertness: Silenor (Doxepin) can cause drowsiness and decreased mental alertness. Do not operate heavy machinery or drive after taking Silenor (Doxepin) until you know how Silenor (Doxepin) affects you. Do not use Silenor (Doxepin) if you drink alcohol.

Liver problems: If you have liver problems, discuss with your doctor how Silenor (Doxepin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Silenor (Doxepin), and whether any special monitoring is needed.

Performing activities while not fully awake: People taking Silenor (Doxepin) 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.

Sleep Apnea: The safety of using Silenor (Doxepin) for people with sleep apnea has not been established.

Pregnancy: Silenor (Doxepin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Silenor (Doxepin), contact your doctor immediately.

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

Children: The safety and effectiveness of using Silenor (Doxepin) have not been established for children under the age of 18.

Seniors: Seniors may be more likely to experience drowsiness or confusion while taking Silenor (Doxepin).