SINEquan (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.

It is very important for your doctor to check the progress of you or your child during regular visits. This helps to adjust the dose and monitor 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 immediately if you or your child start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that concern you or your child, especially if they are new or worsening 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 recklessly. Also inform the doctor if you or your child experience 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 attempted suicide.

Do not take doxepin if you have taken a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Doing so may cause confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, 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 consulting your doctor. Your doctor may want you to slowly reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the chance of withdrawal symptoms, such as headache, nausea, or a general feeling of discomfort or illness.

Silenor® tablets may cause sleep-related behaviors such as sleep-driving, 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 immediately.

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 feel drowsy. Make sure you know how you respond to this medicine before driving, using other medicines, or doing anything else that could be dangerous if you are drowsy or not alert.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants include antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicines, prescription pain medicines or narcotics, medicines 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 while taking this medicine. This medicine may cause symptoms of sedation (such as 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the risks of using the drug must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this drug, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication 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 therapy 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 therapy 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. Nevertheless, elderly patients are more likely to have unwanted effects (eg, confusion or unusual sleepiness) or age-related heart, liver, or kidney issues, 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 drug should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medications 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 using any of the medications 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 physician 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 drug with any of the following medicines is usually not recommended, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how frequently 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 medication with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• 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 drugs may as well 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 Issues

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 issues 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), severe—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 medication from the body.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away 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 sensations
• 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, 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 issues with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Get emergency help right away if any of the following overdose symptoms 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 faint pulse
• weight gain

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have 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 sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased sensitivity of the skin to sunlight
• loss of 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 happen 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.

In the U.S.

• Silenor
• SINEquan

Available Dosage Forms:

• Tablet
• Capsule
• Solution

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

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.

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