This medication is used to treat a certain sleep problem (insomnia). It may help you stay asleep longer and reduce the number of times you awaken during the night. Doxepin belongs to a class of drugs known as tricyclic antidepressants. It is not known how this medication improves sleep, though it may be due to blocking histamine receptors.

Read the Medication Guide provided by your pharmacist before you start taking doxepin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach as directed by your doctor, usually once nightly within 30 minutes before bedtime. Do not take it within 3 hours of a meal because the effect of the medication will be delayed.

Do not take this medication unless you are able to get a full night of sleep (7 to 8 hours) before you must be active again.

The dosage is based on your medical condition, age, and response to treatment. Do not take more than 6 milligrams per day.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition lasts or gets worse after 7 to 10 days.

Drowsiness or nausea may occur. If either of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking doxepin.

At higher doses, doxepin is used to treat a variety of other conditions, including depression and other mental/mood disorders. It can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms if a new antidepressant is started or when the dose is changed.

Get medical help right away if you have any very serious side effects, including:

• eye pain/swelling/redness
• widened pupils
• vision changes (such as seeing rainbows around lights at night, blurred vision)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking doxepin, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as amoxapine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• problems urinating (urinary retention)
• personal or family history of glaucoma (angle-closure type)

This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• cimetidine

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: extreme drowsiness, hallucinations, fast/irregular heartbeat, fainting, slow/shallow breathing, seizures.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other conditions unless directed by your doctor. A different medication may be necessary in those cases.

Usually, insomnia is temporary and requires sleep medications only for a short time. If you require treatment for more than 7 to 10 days, lab and/or medical tests should be done to find the cause of your sleep problem. Keep all medical and lab appointments. Consult your doctor for more details.

As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Talk to your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and avoiding going to bed too early each night.

If you miss a dose, take it as soon as you remember if it is still near bedtime and you have trouble falling asleep. If it is already the next day, take your next dose at the regular time that night at bedtime. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.