Doxepin 6mg Tablets

At low doses (3-6 mg), doxepin acts primarily as a highly selective and potent antagonist of histamine H1 receptors, which is believed to contribute to its sleep-promoting effects. At higher doses, it also inhibits the reuptake of norepinephrine and serotonin, and blocks alpha-1 adrenergic, muscarinic cholinergic, and histamine H2 receptors.

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 may not experience any side effects or may only have mild side effects. 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
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 list is not exhaustive, and you may experience other side effects not mentioned here. 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
Certain health conditions, such as:
+ Urinary retention or glaucoma
+ Sleep apnea
Current or recent use of specific medications, including:
+ Linezolid or methylene blue
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as this may lead to severely high blood pressure)
+ Other medications that can cause drowsiness (your doctor or pharmacist can help you identify these)
If you are breastfeeding, as you should not breastfeed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

After taking this drug, avoid operating a vehicle or engaging in any activities that require alertness, as you may still experience drowsiness the day after consumption. Refrain from these activities until you feel fully awake and alert.

This medication is intended for short-term use. If symptoms persist or recur, consult your doctor to discuss the best course of action.

Some individuals have reported engaging in complex behaviors, such as driving, cooking, eating, or having sex, while in a state of reduced consciousness. Often, these events are not remembered. If you experience such episodes, inform your doctor promptly.

Avoid consuming alcohol while taking this medication, as it may exacerbate its effects. Before using marijuana, cannabis products, or prescription/over-the-counter medications that can impair your reactions, consult your doctor to discuss potential interactions.

Certain individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye examination to assess your risk. Immediately report any eye pain, changes in vision, or swelling and redness around the eyes to your doctor.

This medication can increase your susceptibility to sunburn. Exercise caution when exposed to sunlight, and notify your doctor if you experience unusual sunburn or sensitivity.

If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Be aware of signs of high or low blood sugar, including fruity breath odor, dizziness, rapid breathing, rapid heartbeat, confusion, drowsiness, weakness, flushing, headache, unusual thirst or hunger, frequent urination, shaking, or sweating. Inform your doctor if you experience any of these symptoms.

If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.

Some medications can affect fertility, potentially impacting the ability to conceive. If you have concerns or questions, discuss them with your doctor.

If you are pregnant or planning to become pregnant, inform your doctor to weigh the benefits and risks of using this medication during pregnancy. Taking this drug in the third trimester may lead to health issues in the newborn; therefore, it is crucial to consult your doctor to discuss the potential risks and consequences.

• 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 - risk of QT prolongation and arrhythmias.

• CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics, antihistamines) - additive CNS depression, increased risk of respiratory depression and profound sedation.
• Anticholinergic Agents (e.g., atropine, scopolamine, some antipsychotics, antihistamines) - additive anticholinergic effects (e.g., urinary retention, severe constipation, blurred vision, delirium).
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - may significantly increase doxepin and desmethyldoxepin plasma concentrations, increasing risk of adverse effects.
• Thyroid Hormones - increased risk of cardiac arrhythmias and toxicity.
• Adrenergic Neuron Blocking Agents (e.g., guanethidine, clonidine) - doxepin may block the antihypertensive effect.

• Antihypertensives - additive hypotensive effects.
• Oral Contraceptives - may increase TCA plasma concentrations.
• Sympathomimetics (e.g., epinephrine, norepinephrine) - enhanced pressor response, risk of arrhythmias.
• St. John's Wort - risk of serotonin syndrome.

• Not specifically identified for 6mg doxepin, but general TCA interactions apply.

• Excessive daytime sleepiness or sedation
• Dizziness or lightheadedness
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention
• Confusion or disorientation (especially in elderly)
• Worsening depression or anxiety
• Agitation, restlessness, or irritability
• New or worsening suicidal thoughts or behaviors
• Unusual changes in behavior or mood

Doxepin is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Doxepin and its active metabolite desmethyldoxepin are excreted into breast milk. The American Academy of Pediatrics considers doxepin to be a drug for which the effect on the nursing infant is unknown but may be of concern. Lactation risk is L3 (moderate risk).

Doxepin 6mg is not approved for use in pediatric patients for insomnia. For higher doses used in depression, a Black Box Warning exists regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults. Safety and efficacy have not been established in this population.

Elderly patients are more sensitive to the anticholinergic and sedative effects of doxepin, including increased risk of falls, confusion, and urinary retention. Start with a lower dose (e.g., 3 mg) and titrate carefully. Monitor closely for adverse effects. The Beers Criteria recommend avoiding doxepin in older adults due to its strong anticholinergic properties and sedative effects.

• Doxepin 6mg (Silenor) is specifically formulated for insomnia and acts primarily as a potent H1 receptor antagonist at this low dose, distinguishing its mechanism from its antidepressant effects at higher doses.
• To optimize sleep-inducing effects, advise patients to take doxepin 6mg on an empty stomach (at least 2 hours after a meal) within 30 minutes of bedtime.
• Emphasize the importance of a full 7-8 hours of sleep opportunity to avoid next-day residual sedation.
• Due to its anticholinergic properties, caution should be exercised in patients with conditions exacerbated by anticholinergic effects (e.g., narrow-angle glaucoma, urinary retention).
• While the Black Box Warning for suicidality applies to antidepressants generally, it's important to counsel patients and caregivers, especially young adults, to monitor for worsening mood or behavioral changes, even at low doses, though the risk is lower for insomnia indication.
• Consider 3mg dose for elderly or highly sensitive patients to minimize side effects.

• Other non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone, zaleplon)
• Melatonin receptor agonists (e.g., ramelteon)
• Orexin receptor antagonists (e.g., suvorexant, lemborexant)
• Benzodiazepine receptor agonists (e.g., temazepam, triazolam - generally for short-term use)
• Antihistamines (e.g., diphenhydramine - generally not recommended for chronic insomnia)
• Cognitive Behavioral Therapy for Insomnia (CBT-I) - often considered first-line non-pharmacologic treatment.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.