Doxepin (Sinequan) is a tricyclic antidepressant (TCA). It comes as a capsule that's taken by mouth to treat depression or anxiety in people over the age of 12. But it's not a first-choice option for these conditions because of the risk of side effects, such as drowsiness, dry mouth, and weight gain. The typical dose of doxepin (Sinequan) ranges from 75 mg to 150 mg by mouth once daily. It's available as a generic capsule and oral solution; the brand name (Sinequan) is discontinued.
Note: Doxepin (Silenor) tablets are FDA-approved for insomnia.
Doxepin (Sinequan) is a tricyclic antidepressant (TCA). It affects the amounts of certain chemicals in your brain, including serotonin and norepinephrine, that can be out of balance during depression or anxiety.
Source:Â DailyMed
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
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
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
fast, pounding, or irregular heartbeat or pulse
feeling of warmth
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
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
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
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
difficulty having a bowel movement (stool)
enlargement of the breasts
gas in the stomach
hair loss or thinning of the hair
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
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.
Need to avoid alcohol while taking it
Can take 2 to 3 weeks before you notice the full effects for depression
Can cause withdrawal symptoms if you stop taking the medication suddenly
It's important to keep taking doxepin (Sinequan) even if your symptoms are getting better. It can take 2 to 3 weeks before you notice the full effects of doxepin (Sinequan) when treating depression, but can take longer. You might notice that it works to treat your anxiety symptoms sooner.
Never stop your antidepressant medications without talking to your mental health provider. Suddenly stopping doxepin (Sinequan) can cause withdrawal symptoms, such as nausea, headache, irritability, and trouble sleeping.
Tell your prescriber right away if you notice sudden mood changes or thoughts of harming yourself. Though rare, doxepin (Sinequan) might raise the risk for depression and thoughts of self-harm.
You can take your doxepin (Sinequan) dose at bedtime if it makes you feel sleepy.
Don't drive or do anything that requires you to be alert until you know how doxepin (Sinequan) affects you, since it can make you feel very sleepy and less alert.
Avoid drinking alcohol while taking doxepin (Sinequan). This can raise your risk of side effects, like drowsiness and dizziness, and can lead to serious injuries from falls.
If you're using the oral solution form of doxepin (Sinequan), make sure to use the measuring cup or syringe provided by your pharmacy to measure out your doses. Don't use household spoons, since they might not be accurate and cause you to take the wrong dose.
There isn't enough information available to know if doxepin (Sinequan) is safe to take during pregnancy. In animal studies, doxepin (Sinequan) didn't cause harm to unborn babies, but these studies aren't always representative of what happens in humans. To be safe, if you're pregnant or planning to become pregnant, talk with your healthcare team about the risks and benefits of doxepin (Sinequan) to you and your unborn baby.
Doxepin (Sinequan) can be found in breast milk. If you're breastfeeding or planning to breastfeed, discuss with your healthcare team about the risks and benefits of the medication to you and your baby. Look out for signs of unusual sleepiness or slower breathing in your baby if you're taking doxepin (Sinequan) while breastfeeding.
Doxepin (Sinequan) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Age 24 years or under
People taking doxepin (Sinequan) can experience worsening depression and suicidal thoughts or behavior. The risk of suicidal thoughts or behavior is higher in people 24 years of age and younger with depression or other mental health conditions. Watch for new or worsening depression, suicidal thoughts, or suicidal behavior, especially during the first few months of treatment or when the dose changes. If you or a loved one notices any unusual changes in mood or behavior while you're taking doxepin (Sinequan), let your healthcare professional (HCP) know right away.
Risk factors: Bipolar disorder
Doxepin (Sinequan) shouldn't be used to treat bipolar disorder. Depression can easily be mistaken for the depressive phase of bipolar disorder. Taking doxepin (Sinequan) can trigger a manic episode in people at risk for bipolar disorder. Before starting this medication, your prescriber will make sure you don't have bipolar disorder and assess your risk for this mental health condition.
Risk factors: Taking medications that can raise serotonin
Taking doxepin (Sinequan) with certain medications that raise your serotonin levels can cause a serious condition called serotonin syndrome. This happens when there's too much serotonin in your body. Some examples of other medications that can cause this condition include monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), TCAs, norepinephrine reuptake inhibitors (NRIs), and some herbal medications (e.g., St. John's Wort). Serotonin syndrome can lead to sweating, shaking in the hands, fast heart rate, trouble sleeping, or high fever. It can cause other serious complications, like high blood pressure, seizures, and even death. Contact your prescriber right away if you experience any of these side effects.
It's important to stop taking medications known as MAOIs (e.g., selegiline) 2 weeks before starting doxepin (Sinequan) to avoid side effects. Let your prescriber know if you're taking any other medications that might affect the amount of serotonin in your body, because you might need to be monitored while taking doxepin (Sinequan).
Risk factors: Age 65 years or older | Taking other medications that cause drowsiness | Drinking alcohol
Taking doxepin (Sinequan) can make you sleepy. If you're over 65 years old, you might be at greater risk of falling or confusion due to these effects. Be sure to avoid activities that you need to be fully alert to do, like driving, until you know how this medication affects you. Taking doxepin (Sinequan) with other medications that make you less alert (e.g., benzodiazepines, opioids, antihistamines) raises your risk drowsiness. Work with your prescriber to adjust your dose, move your dose to bedtime, or find other treatment options if these side effects bother you.
People ages 12 years and older: The typical starting dose is 75 mg by mouth daily. Your mental health professional might raise or lower your dose depending on your response to the medication.
The total daily dose can be taken once a day or split up throughout the day. If you're taking doxepin (Sinequan) once a day, the maximum recommended dose is 150 mg per day. If you're splitting up your doses throughout the day, the maximum recommended daily dose is 300 mg.
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.
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.
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.
Glaucoma (eye condition that can cause blindness)
Urinary retention (trouble passing urine)
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Drugs and Lactation Database (LactMed®). (2024). Doxepin. National Institute of Child Health and Human Development.
Finder, R. M., et al. (2012). Doxepin up-to-date: A review of its pharmacological properties and therapeutic efficacy with particular reference to depression. Drugs.
Foong, A. L., et al. (2018). The scoop on serotonin syndrome. Canadian Pharmacists Journal.
Lannett Company, Inc. (2020). Doxepin hydrochloride solution [package insert]. DailyMed.Â
National Alliance on Mental Illness. (2017). Bipolar disorder.
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