Doxepin (for Insomnia), Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat insomnia. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause you to do things that you do not know you are doing, and will not remember the next morning. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take

________________________________________________________________________

What are other names for this medicine?

Type of medicine: tricyclic antidepressant; sleeping pill

Generic and brand names: doxepin (for insomnia), oral; Silenor

What is this medicine used for?

This medicine is taken by mouth to treat insomnia (trouble staying asleep).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Glaucoma
• Heart attack, heart disease, or an irregular heartbeat
• High or low blood pressure
• Liver or kidney disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Mental health problems such as bipolar disorder, depression, schizophrenia, or paranoia
• Pheochromocytoma (a tumor of the adrenal gland)
• Problems with alcohol or substance abuse
• Seizures
• Thyroid disorder
• Trouble urinating or an enlarged prostate gland

Do not take this medicine if you have taken an MAO inhibitor within the past 14 days.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. If you need to take this medicine for more than a few days, do not stop taking it suddenly. You may have to reduce your dosage gradually to avoid withdrawal symptoms. Follow your healthcare provider's instructions.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine 30 minutes before going to bed. Do not take Silenor within 3 hours of a meal, as it may not work as well, or may make you sleepy the next day if taken with or right after a meal. Do not take this medicine unless you are able to get a full night of sleep (7 to 8 hours) before you must be active again.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. If you take only one dose at bedtime and you miss the dose, do not take the medicine in the morning. Wait until the next night. Skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fast or irregular heartbeat, extreme drowsiness, confusion, hallucinations, restlessness, vomiting, blurred vision, fever, sweating, muscle stiffness, lightheadedness, fainting, seizures, coma.

What should I watch out for?

This medicine may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or with dose changes. Talk with your provider about this.

Behavior or mood changes may be caused by the medicine or by depression or another mental health problem. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Anxiety or panic attacks
• Confusion
• Hallucinations
• New or worsening depression
• Suicidal thoughts

After taking this medicine, you may get up out of bed while not being fully awake and do things that you do not know you are doing, and will not remember the next morning. Contact your healthcare provider right away if you find out you have been:

• Sleep-walking
• Sleep-driving
• Making and eating food
• Talking on the phone
• Having sex

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Loss of coordination
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature
• Nausea
• Vomiting
• Diarrhea

This medicine may trigger angle-closure glaucoma. Contact your healthcare provider right away if you have vision changes.

This medicine may continue to make you drowsy even on the day after you take it. Do not drive or operate machinery the day after using this medicine unless you are fully alert.

Contact your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

This medicine may decrease sex drive or cause impotence in men (trouble having and keeping an erection).

This medicine may cause weight changes. Ask your healthcare provider about this.

You may need blood tests regularly to find out how this medicine affects you. Keep all appointments for these tests.

This medicine may increase the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

This medicine may make you may feel dizzy if you get up quickly after sitting or lying down. Getting up slowly may help.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may make your skin more sensitive to the sun and may cause you to sunburn more easily. While you are taking this medicine, avoid long exposure to the sun. While you are in the sun, wear protective clothing and sunscreen lotion until you know how you will react to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

This medicine may cause dry mouth. Sucking hard candy, taking sips of water, or chewing sugarless gum may help.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Seizures; unusual tiredness or weakness; high fever with rash; inability to urinate; fast, slow, or irregular heartbeat; chest pain; fever with increased sweating; severe muscle stiffness; twitching or involuntary movement of your body or face; severe dizziness or fainting; yellowing of the skin or eyes; confusion; hallucinations; severe stomach pain, nausea, vomiting, constipation, or diarrhea; light-colored bowel movements; dark urine; unexplained sore throat; new or sudden mood changes or behavior; suicidal thoughts; worsening depression; unusual bruising or bleeding; vision changes; unusual numbness or tingling.

Other: Headache, mild dizziness, tiredness, dry mouth, nausea, vomiting, bad taste in your mouth, stuffy or runny nose, itching, weight gain or loss, mild constipation or diarrhea, mild stomach pain, blurred vision, testicle swelling in men, breast enlargement, nightmares, change in sexual ability or desire.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antiarrhythmic medicines (to treat irregular heartbeat) such as dronedarone (Multaq), flecainide, propafenone (Rythmol), quinidine, and others
• Antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), rifampin (Rifadin), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), and others
• Antidepressants such as citalopram (Celexa), desipramine (Norpramin), fluoxetine (Prozac), sertraline (Zoloft), and others
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), terbinafine (Lamisil), voriconazole (Vfend), and others
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, iloperidone (Fanapt), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), gabapentin (Neurontin), phenytoin (Dilantin, Phenytek), valproic acid (Depacon, Depakene, Depakote), and others
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Bladder control medicines such as darifenacin (Enablex), mirabegron (Myrbetriq), solifenacin (VESIcare), tolterodine (Detrol), and others
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cabergoline
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), nilotinib (Tasigna), vemurafenib (Zelboraf), and others
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Cisapride
• Clonidine (Catapres, Kapvay)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), pseudoephedrine (Sudafed), and others
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), tolazamide, and others
• Disulfiram (Antabuse)
• Eliglustat (Cerdelga)
• Eluxadoline (Viberzi)
• Epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen)
• HIV medicines such as atazanavir (Reyataz), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), tipranavir (Aptivus), and others
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), norethindrone (Aygestin, Micronor), and others
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, primaquine, quinine, and others
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), arformoterol (Brovana), ipratropium (Atrovent), umeclidinium (Incruse Ellipta), and others
• Metoclopramide (Metozolv, Reglan)
• Midodrine
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), sumatriptan (Alsuma, Imitrex, Sumavel), zolmitriptan (Zomig), and others
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), cyclobenzaprine (Amrix), orphenadrine (Norflex), and tizanidine (Zanaflex)
• Natural remedies such as SAMe, St. John's wort, tryptophan, valerian, yohimbine, and others
• Nausea medicines such as dolasetron (Anzemet), ondansetron (Zofran), granisetron (Sancuso), promethazine, and others
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), naproxen (Aleve, Anaprox, Naprelan), and others
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), oxycodone (OxyContin, Roxicodone), tramadol (ConZip, Ultram), and others
• Parkinson’s disease medicines such as entacapone (Comtan), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), rasagiline (Azilect), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Stimulants such as dextroamphetamine (Dexedrine), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), and others
• Tetrabenazine (Xenazine)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), thyroid USP (Armour Thyroid, Nature-Throid), and others
• Warfarin (Coumadin)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.