Doxepin (Oral)

Generic name: Doxepin

Usage of Doxepin (Oral)

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.

Doxepin (Oral) 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

Agitation

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 or tightness

chills

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

depression

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

drooling

dry mouth

fast, pounding, or irregular heartbeat or pulse

feeling of warmth

fever

flushed, dry skin

fruit-like breath odor

general feeling of tiredness or weakness

headache

hearing loss

hostility

increased hunger

increased thirst

increased urination

irritability

itching or rash

lethargy

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

nausea

nervousness

nightmares

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

restlessness

ringing or buzzing or other unexplained noise in the ears that continues

seeing, hearing, or feeling things that are not there

seizures

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

stomach pain

stupor

sudden loss of consciousness

sweating

swelling of the face, ankles, or hands

swollen glands

trouble 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

Clumsiness

disturbed concentration

drowsiness

enlarged pupils

increased or excessive unconscious or jerking movements

low body temperature

muscle aches

muscle weakness

shivering

sleepiness

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

diarrhea

difficulty having a bowel movement (stool)

enlargement of the breasts

gas in the stomach

hair loss or thinning of the hair

heartburn

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.

Before taking Doxepin (Oral)

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 (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.

Breast Feeding

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.

Bepridil

Bromopride

Cisapride

Dronedarone

Eliglustat

Grepafloxacin

Isocarboxazid

Levoketoconazole

Levomethadyl

Linezolid

Mesoridazine

Methylene Blue

Metoclopramide

Moclobemide

Pimozide

Piperaquine

Potassium Citrate

Ranolazine

Safinamide

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Tranylcypromine

Ziprasidone

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.

Abiraterone Acetate

Acecainide

Aceclofenac

Acemetacin

Adagrasib

Albuterol

Alfentanil

Almotriptan

Amantadine

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Amphetamine

Amtolmetin Guacil

Anagrelide

Apomorphine

Aripiprazole

Aripiprazole Lauroxil

Arsenic Trioxide

Aspirin

Astemizole

Atazanavir

Azimilide

Benzhydrocodone

Benzphetamine

Bretylium

Bromfenac

Bufexamac

Buprenorphine

Bupropion

Buserelin

Butorphanol

Carisoprodol

Celecoxib

Ceritinib

Chloroquine

Choline Salicylate

Citalopram

Clarithromycin

Clofazimine

Clonidine

Clonixin

Clorgyline

Clothiapine

Clozapine

Cobicistat

Codeine

Crizotinib

Cyclobenzaprine

Dabrafenib

Darunavir

Dasatinib

Degarelix

Delamanid

Deslorelin

Desmopressin

Desvenlafaxine

Deutetrabenazine

Dexibuprofen

Dexketoprofen

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Diclofenac

Diflunisal

Dihydrocodeine

Dipyrone

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Droperidol

Droxicam

Duloxetine

Efavirenz

Encorafenib

Enflurane

Entrectinib

Epinephrine

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Etodolac

Etofenamate

Etoricoxib

Etrasimod

Felbinac

Fenfluramine

Fenoprofen

Fentanyl

Fepradinol

Feprazone

Fexinidazole

Fingolimod

Floctafenine

Fluconazole

Flufenamic Acid

Fluoxetine

Flurbiprofen

Fluvoxamine

Formoterol

Foscarnet

Fostemsavir

Frovatriptan

Gatifloxacin

Gemifloxacin

Gepirone

Glasdegib

Glucagon

Glycopyrrolate

Glycopyrronium Tosylate

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Halothane

Histrelin

Hydrocodone

Hydromorphone

Hydroxychloroquine

Hydroxytryptophan

Hydroxyzine

Ibuprofen

Ibutilide

Indomethacin

Inotuzumab Ozogamicin

Iobenguane I 123

Iobenguane I 131

Iproniazid

Isoflurane

Isradipine

Ivabradine

Ivosidenib

Ketoconazole

Ketoprofen

Ketorolac

Lasmiditan

Lefamulin

Lenvatinib

Leuprolide

Levalbuterol

Levofloxacin

Levomilnacipran

Levorphanol

Lisdexamfetamine

Lithium

Lofexidine

Lorcaserin

Lornoxicam

Loxapine

Loxoprofen

Lumiracoxib

Macimorelin

Meclofenamate

Mefenamic Acid

Meloxicam

Meperidine

Metaxalone

Methacholine

Methadone

Methamphetamine

Metronidazole

Milnacipran

Mirtazapine

Mobocertinib

Moricizine

Morniflumate

Morphine

Morphine Sulfate Liposome

Moxifloxacin

Nabumetone

Nafarelin

Nalbuphine

Naproxen

Naratriptan

Nebivolol

Nefopam

Nepafenac

Niflumic Acid

Nilotinib

Nimesulide

Nimesulide Beta Cyclodextrin

Norepinephrine

Octreotide

Olanzapine

Ondansetron

Osilodrostat

Osimertinib

Oxaliplatin

Oxaprozin

Oxycodone

Oxymetazoline

Oxymorphone

Oxyphenbutazone

Ozanimod

Pacritinib

Palonosetron

Panobinostat

Parecoxib

Pargyline

Paroxetine

Pasireotide

Pazopanib

Peginterferon Alfa-2b

Pentamidine

Pentazocine

Phenelzine

Phenylbutazone

Piketoprofen

Pimavanserin

Piroxicam

Pitolisant

Ponesimod

Posaconazole

Pranoprofen

Procainamide

Procarbazine

Prochlorperazine

Proglumetacin

Propyphenazone

Proquazone

Quetiapine

Quinidine

Quizartinib

Rasagiline

Relugolix

Remifentanil

Revefenacin

Ribociclib

Risperidone

Rofecoxib

Salicylic Acid

Salsalate

Scopolamine

Secretin Human

Selegiline

Selpercatinib

Sematilide

Sertindole

Sertraline

Sevoflurane

Siponimod

Sodium Salicylate

Solifenacin

Sotalol

Spiramycin

Sufentanil

Sulfamethoxazole

Sulindac

Sulpiride

Sultopride

Sumatriptan

Sunitinib

Tacrolimus

Tamoxifen

Tapentadol

Tedisamil

Telithromycin

Tenoxicam

Tiaprofenic Acid

Tiotropium

Tocilizumab

Tolfenamic Acid

Tolmetin

Tramadol

Triclabendazole

Trifluoperazine

Trimethoprim

Triptorelin

Valdecoxib

Vandetanib

Vardenafil

Vemurafenib

Venlafaxine

Vilanterol

Vilazodone

Vinflunine

Voclosporin

Vortioxetine

Zolmitriptan

Zotepine

Zuclopenthixol

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

Carbamazepine

Cimetidine

Desogestrel

Dicumarol

Dienogest

Drospirenone

Ethinyl Estradiol

Ethynodiol

Fosphenytoin

Gestodene

Guanethidine

Levonorgestrel

Mestranol

Nomegestrol

Norethindrone

Norgestimate

Norgestrel

Phenprocoumon

Phenytoin

Propoxyphene

Ramelteon

S-Adenosylmethionine

Warfarin

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.

How to use Doxepin (Oral)

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.

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 is not recommended.

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.

Warnings

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 7 to 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.

Tell your doctor if you are pregnant or planning to become pregnant during treatment with this medicine. This medicine may cause symptoms of sedation (eg, breathing problems, sluggishness, low muscle tone, feeding problems, or withdrawal symptoms) in the baby during the third trimester.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

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.

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