Doxepin 3mg Tablets
It is used to treat sleep problems.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hypnotic; Antidepressant; Anxiolytic
Pharmacologic Class
Tricyclic Antidepressant (TCA); Histamine H1 Receptor Antagonist; Norepinephrine and Serotonin Reuptake Inhibitor
Pregnancy Category
Category C
FDA Approved
Mar 1969
DEA Schedule
Not Controlled
Overview
What is this medicine?
Doxepin 3mg is a medication primarily used to help you fall asleep and stay asleep. It works by affecting certain natural substances in your brain that help regulate sleep. It's important to take it exactly as prescribed, usually once a day at bedtime.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication within 30 minutes of bedtime, but not within 3 hours of a meal. It's essential to take this medication only when you can get a full night's sleep, which is at least 7 to 8 hours, before you need to be active again. If you've been taking this medication for an extended period, consult your doctor before stopping, as you may need to gradually taper off the medication.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if you won't be able to get at least 7 hours of sleep after taking the missed dose, skip it and resume your normal schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication within 30 minutes of bedtime, but not within 3 hours of a meal. It's essential to take this medication only when you can get a full night's sleep, which is at least 7 to 8 hours, before you need to be active again. If you've been taking this medication for an extended period, consult your doctor before stopping, as you may need to gradually taper off the medication.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if you won't be able to get at least 7 hours of sleep after taking the missed dose, skip it and resume your normal schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Take doxepin exactly as prescribed, usually 30 minutes before bedtime. Do not take it if you have less than 7-8 hours available for sleep.
- Avoid alcohol consumption while taking doxepin, as it can increase drowsiness and other side effects.
- Avoid driving or operating heavy machinery until you know how doxepin affects you, as it can cause significant drowsiness and impaired coordination.
- Do not stop taking doxepin suddenly without consulting your doctor, especially if you have been on higher doses for depression/anxiety, as withdrawal symptoms can occur.
- Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
- Report any new or worsening mood changes, suicidal thoughts, or unusual behaviors to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
- Doxepin 150mg Capsules
- Doxepin Hcl 10mg/ml Conc 118ml
- Doxepin Hcl 10mg/ml Con 120ml
- Doxepin 100mg (hundred Mg) Capsules
- Doxepin 10mg Capsules
- Doxepin 25mg Capsules
- Doxepin 50mg Capsules
- Doxepin 75mg Capsules
- Doxepin 5% Cream 45gm
- Doxepin 3mg Tablets
- Doxepin 6mg Tablets
- Doxepin 3mg Tablets
- Doxepin 6mg Tablets
- Doxepin 6mg Tablets
- Doxepin 3mg Tablets
- Doxepin 5% Cream 45gm
Dosing & Administration
Adult Dosing
Standard Dose:
3 mg orally once daily at bedtime for insomnia
Dose Range:
3 - 6 mg
Condition-Specific Dosing:
insomnia:
3 mg to 6 mg orally once daily within 30 minutes of bedtime. Doses should not exceed 6 mg per day.
depression_anxiety:
Initial: 25-75 mg/day orally in a single dose or divided doses; Maintenance: 75-150 mg/day (up to 300 mg/day for severe cases). (Note: 3mg tablets are not typically used for these indications)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for insomnia. For depression/anxiety, doses vary by age and weight, generally not recommended for children <12 years.
Adolescent:
Not established for insomnia. For depression/anxiety, initial 25-50 mg/day, gradually increased as needed. (Note: 3mg tablets are not typically used for these indications)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; consider lower initial doses and careful titration due to potential for increased plasma concentrations.
Dialysis:
Not well studied; use with caution. Doxepin is highly protein-bound and not readily dialyzable.
Hepatic Impairment:
Mild:
Use with caution; consider lower initial doses.
Moderate:
Use with caution; consider lower initial doses and careful titration due to reduced metabolism.
Severe:
Contraindicated in severe hepatic impairment due to extensive hepatic metabolism and risk of accumulation.
Pharmacology
Mechanism of Action
Doxepin is a tricyclic antidepressant (TCA) that acts as a potent antagonist of histamine H1 receptors, which is primarily responsible for its sedative effects at low doses (e.g., 3mg, 6mg) used for insomnia. At higher doses, it also inhibits the reuptake of norepinephrine and serotonin at presynaptic neuronal membranes, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. It also has anticholinergic, alpha-1 adrenergic blocking, and weak dopamine reuptake inhibiting properties.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 13-45%) due to significant first-pass metabolism
Tmax:
2-4 hours (doxepin); 4-8 hours (desmethyldoxepin)
FoodEffect:
Food may delay absorption but does not significantly affect overall bioavailability.
Distribution:
Vd:
Approximately 9-33 L/kg
ProteinBinding:
Approximately 80-85%
CnssPenetration:
Yes
Elimination:
HalfLife:
Doxepin: 8-24 hours; Desmethyldoxepin: 28-52 hours
Clearance:
Not precisely quantified, but extensive first-pass metabolism contributes to low bioavailability.
ExcretionRoute:
Primarily renal (as metabolites)
Unchanged:
<3% (doxepin); <6% (desmethyldoxepin)
Pharmacodynamics
OnsetOfAction:
Approximately 30 minutes (for hypnotic effect)
PeakEffect:
1-2 hours (for hypnotic effect)
DurationOfAction:
6-8 hours (for hypnotic effect at low doses); longer for antidepressant effects due to active metabolite.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed 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.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, including:
+ Thoughts of suicide
+ Nervousness
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of high or low blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Difficulty urinating
Feeling extremely nervous or excitable
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Yellowing of the skin or eyes (jaundice)
Ringing in the ears (tinnitus)
Changes in sex drive
Enlarged breasts or nipple discharge
Swelling of the testicles
Important Warning for People with Asthma
If you have asthma, use this medication with caution. Some people taking this medication have experienced worsening of their asthma symptoms. If your asthma symptoms worsen while taking this medication, contact your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy, sleepy, tired, or weak
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dry mouth
Changes in taste
Mouth irritation or mouth sores
Weight gain
Excessive sweating
Flushing
Hair loss
* Headache
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, including:
+ Thoughts of suicide
+ Nervousness
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of high or low blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Difficulty urinating
Feeling extremely nervous or excitable
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Yellowing of the skin or eyes (jaundice)
Ringing in the ears (tinnitus)
Changes in sex drive
Enlarged breasts or nipple discharge
Swelling of the testicles
Important Warning for People with Asthma
If you have asthma, use this medication with caution. Some people taking this medication have experienced worsening of their asthma symptoms. If your asthma symptoms worsen while taking this medication, contact your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy, sleepy, tired, or weak
Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Decreased appetite
Dry mouth
Changes in taste
Mouth irritation or mouth sores
Weight gain
Excessive sweating
Flushing
Hair loss
* Headache
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or dizziness that interferes with daily activities
- Difficulty breathing or shallow breathing
- Fast or irregular heartbeat
- Severe dry mouth, difficulty swallowing, or constipation
- Difficulty urinating
- Blurred vision or eye pain
- Confusion, hallucinations, or disorientation
- Muscle stiffness, fever, or sweating (signs of neuroleptic malignant syndrome, rare)
- New or worsening depression, anxiety, panic attacks
- Thoughts of self-harm or suicide
- Unusual changes in behavior (e.g., agitation, restlessness, aggression)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions and circumstances to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Urinary retention or glaucoma
+ Sleep apnea
Concurrent use of specific medications, including:
+ Linezolid or methylene blue
+ Monoamine oxidase inhibitors (MAOIs) for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days (as this may lead to severely high blood pressure)
Use of other medications that can cause drowsiness, as there are numerous drugs with this potential effect. If you are unsure, consult your doctor or pharmacist.
* Breastfeeding status: Do not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you verify the safety of taking this medication with your existing treatments and conditions. Never initiate, terminate, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and circumstances to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Urinary retention or glaucoma
+ Sleep apnea
Concurrent use of specific medications, including:
+ Linezolid or methylene blue
+ Monoamine oxidase inhibitors (MAOIs) for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days (as this may lead to severely high blood pressure)
Use of other medications that can cause drowsiness, as there are numerous drugs with this potential effect. If you are unsure, consult your doctor or pharmacist.
* Breastfeeding status: Do not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you verify the safety of taking this medication with your existing treatments and conditions. Never initiate, terminate, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
After taking this medication, avoid driving and engaging in other activities that require your full attention. You may still feel drowsy the day after taking this medication, so refrain from these activities until you feel fully alert and awake. This medication is intended for short-term use. If your symptoms return, consult with your doctor.
Risk of Complex Sleep-Related Behaviors
Some individuals have reported engaging in complex behaviors, such as driving, cooking, eating, and having sex, while not fully awake after taking this medication. Often, people do not remember these events. If you experience any of these behaviors, notify your doctor immediately.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
Eye Problems
Certain individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor promptly.
Sun Sensitivity
This medication may increase your risk of sunburn. Exercise caution when spending time outdoors, and inform your doctor if you experience excessive sunburn while taking this medication.
Blood Sugar Monitoring
If you have diabetes, it is essential to closely monitor your blood sugar levels. Notify your doctor if you experience symptoms of high or low blood sugar, such as fruity breath odor, dizziness, rapid breathing, rapid heartbeat, confusion, drowsiness, weakness, flushing, headache, unusual thirst or hunger, frequent urination, shaking, or sweating.
Special Considerations for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Fertility and Pregnancy
Certain medications may affect fertility and the ability to conceive. If you have concerns, discuss them with your doctor. If you are pregnant or plan to become pregnant, inform your doctor to weigh the benefits and risks of taking this medication during pregnancy. Taking this medication in the third trimester may lead to health problems in the newborn, so it is essential to discuss this with your doctor.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
After taking this medication, avoid driving and engaging in other activities that require your full attention. You may still feel drowsy the day after taking this medication, so refrain from these activities until you feel fully alert and awake. This medication is intended for short-term use. If your symptoms return, consult with your doctor.
Risk of Complex Sleep-Related Behaviors
Some individuals have reported engaging in complex behaviors, such as driving, cooking, eating, and having sex, while not fully awake after taking this medication. Often, people do not remember these events. If you experience any of these behaviors, notify your doctor immediately.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential interactions.
Eye Problems
Certain individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor promptly.
Sun Sensitivity
This medication may increase your risk of sunburn. Exercise caution when spending time outdoors, and inform your doctor if you experience excessive sunburn while taking this medication.
Blood Sugar Monitoring
If you have diabetes, it is essential to closely monitor your blood sugar levels. Notify your doctor if you experience symptoms of high or low blood sugar, such as fruity breath odor, dizziness, rapid breathing, rapid heartbeat, confusion, drowsiness, weakness, flushing, headache, unusual thirst or hunger, frequent urination, shaking, or sweating.
Special Considerations for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Fertility and Pregnancy
Certain medications may affect fertility and the ability to conceive. If you have concerns, discuss them with your doctor. If you are pregnant or plan to become pregnant, inform your doctor to weigh the benefits and risks of taking this medication during pregnancy. Taking this medication in the third trimester may lead to health problems in the newborn, so it is essential to discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or coma
- Confusion or agitation
- Hallucinations
- Dilated pupils
- Fast, irregular, or pounding heartbeat
- Low blood pressure (hypotension)
- Seizures
- Respiratory depression or difficulty breathing
- Urinary retention
- Hypothermia
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, including gastric lavage, activated charcoal, and monitoring of cardiac function and vital signs.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hyperpyretic crises, severe convulsions, and death. Allow at least 14 days between discontinuing MAOI and starting doxepin, and vice versa.
- Cisapride
- Pimozide
- Thioridazine
- Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) - increased risk of arrhythmias.
Major Interactions
- CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics, antihistamines) - additive CNS depression, respiratory depression, profound sedation, coma.
- Anticholinergic Agents (e.g., atropine, scopolamine, some antihistamines, antipsychotics) - increased risk of severe anticholinergic effects (e.g., urinary retention, paralytic ileus, delirium).
- Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - enhanced pressor response, risk of arrhythmias.
- CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased doxepin and desmethyldoxepin plasma concentrations, increased risk of adverse effects.
- Thyroid Hormones - increased risk of cardiac arrhythmias and CNS stimulation.
- Guanethidine, Clonidine - doxepin may block the antihypertensive effect.
Moderate Interactions
- Cimetidine - increased doxepin plasma concentrations.
- Oral Contraceptives - may alter doxepin metabolism.
- Barbiturates - may decrease doxepin plasma concentrations.
- Tobacco Smoking - may decrease doxepin plasma concentrations.
- St. John's Wort - may decrease doxepin plasma concentrations or increase serotonergic effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Medical history (including cardiac, seizure, urinary retention, narrow-angle glaucoma)
Rationale: To identify contraindications or conditions requiring caution.
Timing: Prior to initiation
Mental status assessment (especially for suicidal ideation)
Rationale: To assess baseline mood and risk, particularly in young adults.
Timing: Prior to initiation
Electrocardiogram (ECG)
Rationale: To assess for pre-existing cardiac conduction abnormalities, especially in patients with cardiac disease or elderly, as TCAs can prolong QT interval (though less common at low doses).
Timing: Prior to initiation (consider for all, especially if risk factors present)
Routine Monitoring
Efficacy for insomnia (sleep onset, duration, quality)
Frequency: Regularly during treatment, especially in the first few weeks
Target: Improved sleep parameters
Action Threshold: Lack of efficacy after 2-4 weeks; consider dose adjustment or alternative.
Adverse effects (e.g., sedation, dizziness, dry mouth, constipation, urinary retention, orthostatic hypotension)
Frequency: Regularly, especially during dose titration and initial weeks
Target: Minimal or tolerable side effects
Action Threshold: Intolerable side effects; consider dose reduction or discontinuation.
Mental status (for emergence or worsening of suicidal thoughts, behavioral changes)
Frequency: Weekly during initial weeks of therapy, then periodically
Target: Stable or improved mood, absence of suicidal ideation
Action Threshold: New or worsening suicidal thoughts, agitation, or unusual changes in behavior; immediate clinical evaluation required.
Blood pressure (especially orthostatic)
Frequency: Periodically, especially in elderly or those prone to hypotension
Target: Stable blood pressure
Action Threshold: Significant orthostatic drop; consider dose reduction or alternative.
Symptom Monitoring
- Excessive sedation or drowsiness
- Dizziness or lightheadedness (especially when standing)
- Dry mouth
- Constipation
- Blurred vision
- Difficulty urinating
- Confusion or disorientation (especially in elderly)
- New or worsening depression
- Suicidal thoughts or behavior
- Agitation, restlessness, or irritability
- Panic attacks
- Insomnia (paradoxical worsening)
- Mania or hypomania
- Unusual changes in behavior
Special Patient Groups
Pregnancy
Doxepin is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, tremors, hypertonia) have been reported with tricyclic antidepressant use during the third trimester.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital malformations, though data are conflicting and not conclusive for TCAs.
Second Trimester:
Less data available, but generally considered safer than first trimester.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, tremors, hypertonia, seizures) and persistent pulmonary hypertension of the newborn (PPHN).
Lactation
Doxepin and its active metabolite are excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, poor feeding, weight loss, irritability), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Monitor infants for drowsiness, feeding difficulties, and developmental milestones.
Infant Risk:
L3 (Moderate risk). Potential for sedation, poor feeding, and other CNS effects in the infant.
Pediatric Use
Safety and effectiveness of doxepin for insomnia (3mg, 6mg) have not been established in pediatric patients. For depression/anxiety, doxepin is generally not recommended for children under 12 years of age. All antidepressants carry a Black Box Warning for increased risk of suicidality in children, adolescents, and young adults.
Geriatric Use
Elderly patients are more sensitive to the anticholinergic, sedative, and hypotensive effects of doxepin. Use with caution, starting with lower doses (e.g., 3mg) and titrating slowly. Increased risk of falls, confusion, and urinary retention. Avoid in elderly patients with dementia-related psychosis due to increased mortality risk.
Clinical Information
Clinical Pearls
- Doxepin 3mg and 6mg are specifically formulated and approved for insomnia, leveraging its potent H1 antagonism at low doses, rather than its antidepressant properties.
- Patients should be advised to take doxepin 3mg within 30 minutes of bedtime and ensure they have at least 7-8 hours available for sleep to avoid residual sedation ('hangover effect').
- Despite the low dose, doxepin is still a TCA, and clinicians should be aware of potential drug interactions and contraindications associated with the class, particularly with MAOIs and other CNS depressants.
- Anticholinergic side effects (dry mouth, constipation, urinary retention, blurred vision) are common even at low doses, especially in sensitive individuals like the elderly.
- The Black Box Warning for suicidality applies to doxepin as a class effect of antidepressants, even when prescribed for insomnia, and patients/caregivers should be counseled accordingly.
Alternative Therapies
- Other hypnotics: Zolpidem (Ambien), Eszopiclone (Lunesta), Zaleplon (Sonata), Suvorexant (Belsomra), Lemborexant (Dayvigo), Ramelteon (Rozerem)
- Other antidepressants with sedative properties (off-label for insomnia): Trazodone, Mirtazapine
- Antihistamines (off-label for insomnia): Diphenhydramine, Hydroxyzine
- Cognitive Behavioral Therapy for Insomnia (CBT-I) - often considered first-line non-pharmacologic treatment.
Cost & Coverage
Average Cost:
$20 - $100 per 30 tablets (3mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic); Tier 3 (Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.