established increased risk of major birth defects or miscarriage; there are risks of poor neonatal adaptation with exposure to drug during pregnancy Neonatal adverse effects Neonates exposed to TCAs, including doxepin, late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; such complications can arise immediately upon delivery Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hyperreflexia, tremor, jitteriness, irritability and constant crying. These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome Monitor neonates who were exposed to drug in third trimester of pregnancy for poor neonatal adaptation syndrome Animal data Based on results from animal fertility studies conducted in rats, doxepin may reduce fertility in females and males of reproductive potential In animal reproduction studies, oral administration of doxepin to rats and rabbits during period of organogenesis caused adverse developmental effects at doses 65 and 23 times maximum recommended human dose (MRHD) of 6 mg/day based on AUC, respectively Oral administration to pregnant rats during pregnancy and lactation resulted in decreased pup survival and a delay in pup growth at doses 60 times MRHD based on AUC Lactation Data from published report presence of drug and metabolite in human milk; there are reports of excess sedation, respiratory depression, poor sucking and swallowing, and hypotonia in breastfed infants exposed to drug There are no data on effects of drug on milk production; because of potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during therapy Infants exposed to drug through breast milk should be monitored for excess sedation, respiratory depression and hypotoniaPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Exact mechanism for doxepin's sleep maintenance effect is unknown; however, doxepin's action is believed to result from antagonism of the histamine H1 receptor Mechanism of action for depression is unknown; may increase CNS synaptic concentrations of serotonin and norepinephrine by inhibiting reuptake Absorption Peak plasma time: 2 hr Onset: >2 weeks (depression) Distribution Protein bound: 80% Metabolism Hepatic CYP2D6, CYP2C19 Metabolites: N-demethyldoxepin Elimination Half-life: 6-8 hr Excretion: Urine BRAND FORM. UNIT PRICE PILL IMAGE doxepin oral- 10 mg capsuledoxepin oral- 100 mg capsuledoxepin oral- 10 mg capsuledoxepin oral- 50 mg capsuledoxepin oral- 100 mg capsuledoxepin oral- 75 mg capsuledoxepin oral- 50 mg capsuledoxepin oral- 25 mg capsuledoxepin oral- 10 mg capsuledoxepin oral- 10 mg capsuledoxepin oral- 10 mg/mL liquiddoxepin oral- 25 mg capsuledoxepin oral- 10 mg capsuledoxepin oral- 75 mg capsuledoxepin oral- 50 mg capsuledoxepin oral- 100 mg capsuledoxepin oral- 75 mg capsuledoxepin oral- 25 mg capsuledoxepin oral- 75 mg capsuledoxepin oral- 150 mg capsuledoxepin oral- 75 mg capsuledoxepin oral- 100 mg capsuledoxepin oral- 25 mg capsuledoxepin oral- 50 mg capsuledoxepin oral- 100 mg capsuledoxepin oral- 50 mg capsuledoxepin oral- 25 mg capsuledoxepin oral- 10 mg/mL liquiddoxepin oral- 6 mg tabletdoxepin oral- 3 mg tabletdoxepin oral- 3 mg tabletdoxepin oral- 6 mg tabletSilenor oral- 6 mg tabletSilenor oral- 3 mg tabletdoxepin topical- 5 % creamCopyright © 2010 First DataBank, Inc.Select a drug:doxepin oraldoxepin topicalPrint Patient Educationdoxepin oral DOXEPIN (SLEEP) - ORAL (dox-EH-pin) COMMON BRAND NAME(S): Silenor USES: This medication is used to treat a certain sleep problem (insomnia). It may help you stay asleep longer and reduce the number of times you awaken during the night. Doxepin belongs to a class of drugs known as tricyclic antidepressants. It is not known how this medication improves sleep, though it may be due to blocking histamine receptors. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking doxepin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth on an empty stomach as directed by your doctor, usually once nightly within 30 minutes before bedtime. Do not take it within 3 hours of a meal because the effect of the medication will be delayed.Do not take this medication unless you are able to get a full night of sleep (7 to 8 hours) before you must be active again.The dosage is based on your medical condition, age, and response to treatment. Do not take more than 6 milligrams per day.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Tell your doctor if your condition lasts or gets worse after 7 to 10 days. SIDE EFFECTS: Drowsiness or nausea may occur. If either of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking doxepin.At higher doses, doxepin is used to treat a variety of other conditions, including depression and other mental/mood disorders. It can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms if a new antidepressant is started or when the dose is changed.Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking doxepin, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as amoxapine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems urinating (urinary retention), personal or family history of glaucoma (angle-closure type).This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.This medication passes into breast milk and may have undesirable effects in a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: cimetidine.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, hallucinations, fast/irregular heartbeat, fainting, slow/shallow breathing, seizures. NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for other conditions unless directed by your doctor. A different medication may be necessary in those cases.Usually, insomnia is temporary and requires sleep medications only for a short time. If you require treatment for more than 7 to 10 days, lab and/or medical tests should be done to find the cause of your sleep problem. Keep all medical and lab appointments. Consult your doctor for more details.As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Talk to your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and avoiding going to bed too early each night. MISSED DOSE: If you miss a dose, take it as soon as you remember if it is still near bedtime and you have trouble falling asleep. If it is already the next day, take your next dose at the regular time that night at bedtime. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised April 2023. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE