Silenor (Doxepin)

It's usually taken one to three times a day and may be taken with or without food.

Try to take SILENOR at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Take SILENOR exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

SILENOR concentrate (oral liquid) comes with a specially marked dropper for measuring the dose. Ask your pharmacist to show you how to use the dropper.

Dilute the concentrate in four ounces (120 mL) of water; whole or skim milk; or orange, grapefruit, tomato, prune, or pineapple juice just before taking it. Do not mix it with carbonated beverages (soft drinks).

It may take several weeks or longer for you to feel the full effect of SILENOR. Continue to take SILENOR even if you feel well.

Do not stop taking SILENOR without talking to your doctor. Your doctor will probably want to decrease your dose gradually.

SILENOR Overdose

Call 911 or a poison control line.

An overdose of SILENOR can be fatal.

Missed Dose of SILENOR

Take the missed dose as soon as you remember.

Skip the missed dose if it's almost time for your next scheduled dose.

Do not take extra medicine to make up the missed dose.

SILENOR may cause side effects. Call your doctor if any of these symptoms are severe or do not go away:

• Nausea
• Drowsiness
• Weakness or tiredness
• Nightmares
• Dry mouth
• Skin more sensitive to sunlight than usual
• Changes in appetite or weight
• Constipation
• Difficulty urinating
• Frequent urination
• Blurred vision
• Changes in sex drive or ability
• Excessive sweating

If you experience any of the following symptoms, call your doctor immediately:

• Jaw, neck, and back muscle spasms
• Slow or difficult speech
• Shuffling walk
• Uncontrollable shaking of a part of the body
• Fever
• Difficulty breathing or swallowing
• Rash
• Yellowing of the skin or eyes
• Irregular heartbeat

You should not take SILENOR if you have glaucoma or problems with urination.

SILENOR is safe for elderly people, but there may be an increased risk of confusion or drowsiness. Dosing may also differ due to decreased kidney function or heart problems.

SILENOR is not approved for use in children under age 12.

Do not use if you are allergic to SILENOR or to similar medications such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

Do not use SILENOR if you have taken a monoamine oxidase inhibitor (MAOI) in the past 14 days. A dangerous drug interaction could occur.

MAOIs include:

• Furazolidone (Furoxone)
• Isocarboxazid (Marplan)
• Linezolid (Zyvox)
• Phenelzine (Nardil)
• Rasagiline (Azilect)
• Selegiline (Emsam)
• Tranylcypromine (Parnate)

Report any new or worsening symptoms to your doctor, including:

• Behavior or mood changes, such as feeling impulsive, irritable, agitated, hostile, aggressive, or restless
• Anxiety
• Panic attacks
• Trouble sleeping
• Increased depression
• Suicidal thoughts or thoughts of harming yourself
• Hyperactivity (mental or physical)

To make sure SILENOR is safe for you, tell your doctor if you have:

• Sleep apnea (breathing stops during sleep)
• Diabetes (SILENOR may raise or lower blood sugar)
• Bipolar disorder (manic-depression)

Some children, teenagers, and young adults have thoughts of suicide when first taking an antidepressant.

Your doctor will need to check your progress at regular visits while you are using SILENOR.

Your family or other caregivers should also be alert to changes in your mood or symptoms.

SILENOR and Pregnancy

It's not known whether SILENOR will harm an unborn baby.

Tell your doctor if you are pregnant or might become pregnant while using this medication.

SILENOR is excreted into human breast milk in small amounts. Respiratory depression has been reported in one breastfeeding infant.

Do not give this medicine to a child without medical advice.

Taking SILENOR with other drugs that make you sleepy or slow your breathing can increase these effects.

Ask your doctor before taking SILENOR with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Before taking SILENOR, tell your doctor if you have used a selective serotonin-reuptake inhibitor or SSRI antidepressant in the past five weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

You must wait at least five weeks after stopping fluoxetine (Prozac) before you can take SILENOR.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with SILENOR, especially:

• Bupropion (Wellbutrin)
• Cimetidine (Tagamet)
• St. John's wort (Hypericum perforatum)
• Terbinafine (Lamisil)
• Tolazamide (Tolinase)
• Antidepressants or other medication used to treat mental illness
• Heart rhythm medications such as flecainide (Tambocor), propafenone (Rythmol), or quinidine (Quinora)

This list is not complete and many other drugs can interact with SILENOR.

This includes prescription and over-the-counter (OTC) medicines, vitamins, herbal supplements, and recreational drugs.

Give a list of all your medicines to any healthcare provider who treats you.

SILENOR and Alcohol

Do not drink alcohol while taking SILENOR.

SILENOR can increase the effects of alcohol, which could be dangerous.

SILENOR may impair your thinking or reaction time, so avoid driving or operating heavy machinery until you're aware of its effects on you.