Silenor contains the active ingredient doxepin hydrochloride in tablet form, available in 3 mg and 6 mg dosages for oral administration. Doxepin belongs to a class of medications known for their geometric isomeric mixture, with each tablet comprising doxepin hydrochloride as a white crystalline powder. The tablets also include inactive ingredients like colloidal silicon dioxide, crospovidone, microcrystalline cellulose, and magnesium stearate.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication on an empty stomach, and not within 3 hours of a meal. This medication should be taken within 30 minutes of going to sleep and only when you are able to get a full night of sleep before you must be active again. Do not take it more often than directed. Do not stop taking this medication suddenly except upon the advice of your care team. Stopping this medication too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication should only be taken before going to sleep. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression
• Trouble passing urine
• Unusual sleep behaviors or activities you do not remember such as driving, eating, or sexual activity

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Constipation
• Dizziness
• Drowsiness the day after use
• Dry mouth
• Tremors
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder
• Depression
• Difficulty passing urine
• Glaucoma
• Heart disease
• Liver disease
• Lung or breathing disease, such as asthma or sleep apnea
• Prostate trouble
• Schizophrenia
• Substance use disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to doxepin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Arsenic trioxide
• Certain medications for irregular heartbeat or other heart conditions
• Cisapride
• Halofantrine
• Levomethadyl
• Linezolid
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue
• Other medications for depression
• Phenothiazines, such as perphenazine, thioridazine, and chlorpromazine
• Pimozide
• Procarbazine
• Sparfloxacin
• St. John's Wort

This medication may also interact with the following:

• Cimetidine
• Tolazamide
• Ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. Talk to your care team if you still have trouble sleeping within 7 to 10 days of using this medication. This may mean there is another cause for your sleep problems.

Do not take this medication unless you are able to get a full night of sleep before you must be active again. After taking this medication, do not drive, use machinery, or do anything that needs mental alertness. Take this medication only within 30 minutes of going to bed and then confine your activities to those needed to get ready for sleep. You may still be drowsy the morning after taking this medication. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells.

You may do unusual sleep behaviors or activities you do not remember the day after taking this medication. Activities include driving, making or eating food, talking on the phone, sexual activity, or sleep walking. Stop taking this medication and call your care team right away if you find out you have done activities like this.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

This medication may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

This medication can cause constipation. If you do not have a bowel movement for 3 days, call your care team.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.