When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to doxepin or similar medicines.

How to Use This Medicine:
Capsule, Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Sinequan® oral liquid:
  
  • Measure the dose with the dropper that comes with the medicine.
  • Mix the medicine with 120 mL (4 ounces) of water, milk, or fruit juice (orange, grapefruit, tomato, prune, or pineapple) before you drink it. Do not use grape juice or carbonated beverages (soda pop). Mix the medicine just before you take your dose. Do not prepare it ahead of time.
• Silenor® tablet:
  
  • Do not take the tablet within 3 hours of a meal. It may not work as well, or it might make you sleepy the next day.
  • Take the tablet 30 minutes before you go to bed.
  • Do not take the medicine unless you can get a full night's sleep (7 to 8 hours).
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor within the past 14 days.
• Some foods and medicines can affect how doxepin works. Tell your doctor if you are using any of the following:
  
  • Cimetidine, tolazamide
  • Other medicines for depression (such as citalopram, escitalopram, fluoxetine, paroxetine, sertraline), a phenothiazine medicine (such as chlorpromazine, perphenazine, promethazine, prochlorperazine, thioridazine), or medicines for heart rhythm problems (such as flecainide, propafenone, quinidine)
• Do not drink alcohol while you are using this medicine.
• This medicine can intensify the effects of other medicine that makes you sleepy, such as allergy medicine and narcotic pain medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, problems urinating, glaucoma, sleep apnea, or a history of mental illness.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Silenor® tablets may cause you to do things while you are still asleep that you may not remember the next morning, such as driving a car, having sex, or eating food. Tell your doctor right away if you learn that this has happened.
• This medicine may make you drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Silenor® tablets: Call your doctor if you still have trouble sleeping after you take this medicine for 7 to 10 days.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in behavior, or thoughts of hurting yourself or others
• Eye pain, vision changes, seeing halos around lights
• Fast, pounding, or uneven heartbeat
• Feeling nervous, restless, anxious, agitated, or excited for no reason
• Seizures or tremors
• Severe confusion, or seeing or hearing things that are not there
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Dizziness or drowsiness
• Dry mouth

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088