Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Silenor
  2. Sinequan

Descriptions


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.

This product is available in the following dosage forms:

  • Capsule
  • Solution
  • Tablet

Before Using

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:

Allergies

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.

Pediatric

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.

Geriatric

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 (e.g., 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.

Pregnancy

Information about this doxepin-oral-route
Pregnancy Category Explanation
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.

Breastfeeding

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.

Drug Interactions

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.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • Grepafloxacin
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Pimozide
  • Piperaquine
  • Ranolazine
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Tranylcypromine

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.

  • Acecainide
  • Almotriptan
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Amprenavir
  • Arsenic Trioxide
  • Astemizole
  • Azimilide
  • Bretylium
  • Bupropion
  • Chloroquine
  • Clarithromycin
  • Clonidine
  • Clorgyline
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Desvenlafaxine
  • Dextromethorphan
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Droperidol
  • Enflurane
  • Epinephrine
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Etilefrine
  • Fentanyl
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Frovatriptan
  • Gatifloxacin
  • Gemifloxacin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroxytryptophan
  • Ibutilide
  • Indacaterol
  • Iobenguane I 123
  • Iproniazid
  • Isoflurane
  • Isradipine
  • Ivabradine
  • Ketoconazole
  • Levalbuterol
  • Levomilnacipran
  • Levothyroxine
  • Lorcaserin
  • Methoxamine
  • Midodrine
  • Moricizine
  • Moxifloxacin
  • Naratriptan
  • Nefopam
  • Norepinephrine
  • Octreotide
  • Ondansetron
  • Oxilofrine
  • Pargyline
  • Pazopanib
  • Pentamidine
  • Phenelzine
  • Phenylephrine
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Quetiapine
  • Quinidine
  • Rasagiline
  • Risperidone
  • Selegiline
  • Sematilide
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Tapentadol
  • Tedisamil
  • Telithromycin
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimethoprim
  • Umeclidinium
  • Vandetanib
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Vortioxetine
  • Ziprasidone
  • Zolmitriptan
  • Zotepine

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.

  • Acenocoumarol
  • Arbutamine
  • Bethanidine
  • Cannabis
  • Carbamazepine
  • Cimetidine
  • Dicumarol
  • Fosphenytoin
  • Guanethidine
  • Paroxetine
  • Phenprocoumon
  • Phenytoin
  • Propoxyphene
  • Ramelteon
  • S-Adenosylmethionine
  • Warfarin

Other Interactions

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 (mental disease with alternating episodes of mania and depression), or risk of or
  • Glaucoma, narrow-angle, untreated or
  • Urinary retention (trouble urinating), or risk of—Should not be used in patients with these conditions.
  • Breathing problems or
  • Sleep apnea (breathing stops during sleeping), severe—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

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, 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.

Dosing

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 and dose must be determined by your doctor.
  • 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.

Missed Dose

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.

Storage

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

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 (e.g., 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.

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

  1. Abdominal or stomach pain
  2. agitation
  3. black, tarry stools
  4. bleeding gums
  5. blood in the urine or stools
  6. blurred vision
  7. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  8. canker sores
  9. chest pain
  10. chills
  11. clay-colored stools
  12. cold sweats
  13. confusion about identity, place, and time
  14. convulsions
  15. cool, pale skin
  16. cough or hoarseness
  17. dark urine
  18. decrease in the frequency of urination
  19. decrease in urine volume
  20. decreased urine output
  21. depression
  22. difficulty in passing urine (dribbling)
  23. difficulty with breathing
  24. difficulty with speaking
  25. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  26. drooling
  27. dry mouth
  28. fast, pounding, or irregular heartbeat or pulse
  29. feeling of warmth
  30. fever
  31. flushed, dry skin
  32. fruit-like breath odor
  33. general feeling of tiredness or weakness
  34. headache
  35. hearing loss
  36. hostility
  37. increased hunger
  38. increased thirst
  39. increased urination
  40. irritability
  41. itching
  42. lethargy
  43. lip smacking or puckering
  44. loss of appetite
  45. loss of balance control
  46. loss of bladder control
  47. lower back or side pain
  48. mood or mental changes
  49. muscle spasm or jerking of all extremities
  50. muscle trembling, jerking, or stiffness
  51. muscle twitching
  52. nausea
  53. nervousness
  54. nightmares
  55. noisy breathing
  56. painful or difficult urination
  57. pinpoint red spots on the skin
  58. pounding in the ears
  59. puffing of the cheeks
  60. rapid or worm-like movements of the tongue
  61. rapid weight gain
  62. rash
  63. redness of the face, neck, arms, and occasionally, upper chest
  64. restlessness
  65. ringing or buzzing or other unexplained noise in the ears that continues
  66. seeing, hearing, or feeling things that are not there
  67. seizures
  68. shakiness and unsteady walk
  69. shakiness in the legs, arms, hands, or feet
  70. shortness of breath
  71. shuffling walk
  72. sore throat
  73. sores, ulcers, or white spots on the lips, tongue, or in the mouth
  74. slurred speech
  75. stiffness of the limbs
  76. stupor
  77. sudden loss of consciousness
  78. sweating
  79. swelling of the face, ankles, or hands
  80. swollen glands
  81. tightness in the chest
  82. troubled breathing
  83. twisting movements of the body
  84. uncontrolled chewing movements
  85. uncontrolled movements, especially of the arms, face, legs, neck, and back
  86. unexplained weight loss
  87. unpleasant breath odor
  88. unsteadiness, trembling, or other problems with muscle control or coordination
  89. unusual bleeding or bruising
  90. unusual tiredness or weakness
  91. vomiting of blood
  92. wheezing
  93. yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Clumsiness
  2. disturbed concentration
  3. drowsiness
  4. enlarged pupils
  5. increased or excessive unconscious or jerking movements
  6. low body temperature
  7. muscle aches
  8. muscle weakness
  9. shivering
  10. sleepiness
  11. weak or feeble pulse
  12. 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

  1. Change in taste or bad, unusual or unpleasant (after)taste
  2. decreased interest in sexual intercourse
  3. diarrhea
  4. difficulty having a bowel movement (stool)
  5. enlargement of the breasts
  6. gas in stomach
  7. hair loss or thinning of the hair
  8. heartburn
  9. inability to have or keep an erection
  10. increased in sexual ability, desire, drive, or performance
  11. increased interest in sexual intercourse
  12. increased sensitivity of the skin to sunlight
  13. loss in sexual ability, desire, drive, or performance
  14. redness or other discoloration of the skin
  15. severe sunburn
  16. swelling of the breasts or breast soreness in both females and males
  17. swelling of the testicles
  18. unexpected or excess milk flow from breasts
  19. 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.