Generic Name: doxepin (Oral route)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antidepressant
Pharmacologic Class: Antidepressant, Tricyclic
Uses For Silenor
Doxepin is used to treat anxiety or depression. It is also used to treat insomnia (trouble with sleeping).
Doxepin is a tricyclic antidepressant (TCA). It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain.
This medicine is available only with your doctor's prescription.
Before Using Silenor
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of doxepin capsules and solution for the treatment of depression and anxiety in children younger than 12 years of age. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of doxepin tablets for the treatment of insomnia in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doxepin in the elderly. However, elderly patients are more likely to have unwanted effects (eg, confusion or unusual drowsiness) or age-related heart, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving doxepin.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Arsenic Trioxide
- Eslicarbazepine Acetate
- Iobenguane I 123
- Morphine Sulfate Liposome
- Peginterferon Alfa-2b
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bipolar disorder (mood disorder with mania and depression), or risk of or
- Breathing problems or
- Psychosis (mental illness) or
- Sleep apnea (breathing stops during sleeping), severe—Use with caution. May make these conditions worse.
- Glaucoma or
- Urinary retention (trouble urinating), or risk of—Should not be used in patients with these conditions.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of doxepin
This section provides information on the proper use of a number of products that contain doxepin. It may not be specific to Silenor. Please read with care.
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you are using the Sinequan® oral liquid or capsule once a day, you may take it at bedtime.
To use the Sinequan® oral liquid:
- Measure the dose with the calibrated dropper that comes with the medicine.
- Mix each dose with about one-half glass (4 ounces) of water, whole or skimmed milk, orange juice, grapefruit juice, tomato juice, prune juice, or pineapple juice. Do not mix this medicine with grape juice or carbonated beverages (soda pop). Mix the medicine just before taking the dose. Do not prepare it ahead of time.
To use the Silenor® tablet:
- Do not take this medicine within 3 hours of a meal. It may not work as well, or it might make you sleepy the next day if you take it with or right after a meal.
- Take the tablet 30 minutes before going to bed, when you are ready to go to sleep.
- Do not take the medicine unless you can get a full night's sleep (7 to 8 hours). If you wake up too soon, you may feel drowsy from the medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (capsules or solution):
- For depression or anxiety:
- Adults and children 12 years of age and older—At first, 75 milligrams (mg) once a day or in divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day.
- Children younger than 12 years of age—Use is not recommended.
- For depression or anxiety:
- For oral dosage form (tablets):
- For insomnia:
- Adults—6 milligrams (mg) once a day.
- Older adults—At first, 3 mg once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For insomnia:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Silenor
It is very important that your doctor check the progress of you or your child at regular visits to allow for changes in the dose and to check for any unwanted effects.
For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.
Do not take doxepin if you have taken a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. If you do, you may have confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.
If you or your child are using this medicine for depression or anxiety, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms, such as headache, nausea, or a general feeling of discomfort or illness.
Silenor® tablets may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If any of these reactions occur, tell your doctor right away.
If you think you need to take Silenor® tablets for more than 10 days, talk to your doctor.
This medicine may cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you or your child are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.
Silenor Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Incidence not known
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- canker sores
- chest pain
- clay-colored stools
- cold sweats
- confusion about identity, place, and time
- cool, pale skin
- cough or hoarseness
- dark urine
- decrease in the frequency of urination
- decrease in urine volume
- decreased urine output
- difficulty in passing urine (dribbling)
- difficulty with breathing
- difficulty with speaking
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- fast, pounding, or irregular heartbeat or pulse
- feeling of warmth
- flushed, dry skin
- fruit-like breath odor
- general feeling of tiredness or weakness
- hearing loss
- increased hunger
- increased thirst
- increased urination
- itching or rash
- lip smacking or puckering
- loss of appetite
- loss of balance control
- loss of bladder control
- lower back or side pain
- mood or mental changes
- muscle spasm or jerking of all extremities
- muscle trembling, jerking, or stiffness
- muscle twitching
- noisy breathing
- painful or difficult urination
- pinpoint red spots on the skin
- pounding in the ears
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- rapid weight gain
- redness of the face, neck, arms, and occasionally, upper chest
- ringing or buzzing or other unexplained noise in the ears that continues
- seeing, hearing, or feeling things that are not there
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- shuffling walk
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or in the mouth
- slurred speech
- stiffness of the limbs
- sudden loss of consciousness
- swelling of the face, ankles, or hands
- swollen glands
- tightness in the chest
- troubled breathing
- twisting movements of the body
- uncontrolled chewing movements
- uncontrolled movements, especially of the arms, face, legs, neck, and back
- unexplained weight loss
- unpleasant breath odor
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- disturbed concentration
- enlarged pupils
- increased or excessive unconscious or jerking movements
- low body temperature
- muscle aches
- muscle weakness
- weak or feeble pulse
- weight gain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Incidence not known
- Change in taste or bad, unusual or unpleasant (after) taste
- decreased interest in sexual intercourse
- difficulty having a bowel movement (stool)
- enlargement of the breasts
- gas in the stomach
- hair loss or thinning of the hair
- inability to have or keep an erection
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sensitivity of the skin to sunlight
- loss in sexual ability, desire, drive, or performance
- redness or other discoloration of the skin
- severe sunburn
- swelling of the breasts or breast soreness in both females and males
- swelling of the testicles
- unexpected or excess milk flow from breasts
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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