Doxepin

Doxepin is a tricyclic antidepressant approved for depression or sleep disorders, depending on the formulation.

Doxepin capsules and oral solution are approved for the treatment of major depressive disorder (severe depression) in adults.

Doxepin tablets (Silenor and generics) are used to help people with insomnia fall asleep.

This medicine may also be used off-label to treat other conditions, such as anxiety.

Doxepin first gained FDA approval on September 23, 1969.

Take doxepin exactly as your healthcare provider tells you to take it. Your doctor may change your dose if needed.

Doxepin capsules for depression

• For most patients with mild to moderate depression, a starting dosage of 75 mg/day is recommended. The dose should be increased slowly, depending on response (optimum dose range 75-150 mg/day; maximum dose of 300 mg/day
• In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower dosages of 25 to 50 mg/day have often been effective.

Doxepin oral solution for depression

Use the calibrated dropper that comes with doxepin hydrochloride oral solution to measure the prescribed dose.

• The calibrated dropper has markings at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

Mix your prescribed dose with 120 mL (4 ounces) of water, whole or skimmed milk, or orange, grapefruit, tomato, prune, or pineapple juice. Do not mix with other liquids.

Take the dose right away after mixing.

Doxepin tablets for sleep

Take doxepin within 30 minutes of bedtime. After taking doxepin, you should only do activities to get ready for bed.

Do not take doxepin tablets within 3 hours of a meal. Doxepin tablets may make you sleepy the next day if taken with or right after a meal.

Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Do not take doxepin if you:

• Are allergic to doxepin, or any of the ingredients in the formulation you are taking
• Have glaucoma
• Have or have had trouble urinating
• Are taking, or have stopped taking within the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you stop treatment with doxepin.

Before taking doxepin, tell your healthcare provider about all of your medical conditions, including if you:

• Have a history of depression, mental illness, bipolar disorder, mania, hypomania, or suicidal thoughts or behavior
• Have severe sleep apnea
• Have kidney or liver problems
• Have a history of drug or alcohol abuse or addiction
• Have or had seizures or convulsions
• Are you pregnant or plan to become pregnant
• Are you breastfeeding or plan to breastfeed.

Pregnancy

Taking doxepin in the third trimester of pregnancy may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant during treatment with doxepin.

Babies born to mothers who take certain medicines, including doxepin, during the third trimester of pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, low muscle tone, feeding problems, and withdrawal symptoms.

There is a pregnancy registry for women who are exposed to doxepin hydrochloride during pregnancy. The purpose of this registry is to collect information about the health of women exposed to doxepin hydrochloride and their babies. If you become pregnant during treatment with doxepin hydrochloride, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

Breastfeeding

Doxepin can pass into your breast milk and may harm your baby. You should not breastfeed during treatment with doxepin. Talk to your healthcare provider about the best way to feed your baby during treatment with doxepin.

Warnings

When doxepin is used at a higher dose (such as for depression [doxepin capsules and oral solution]), it carries a Boxed Warning for an increased risk of suicidal thoughts and actions.

Increased risk of suicidal thoughts and actions

Doxepin hydrochloride capsules, doxepin oral solution, and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Doxepin hydrochloride capsules and oral solution are not for use in children.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call your health care provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions.
• Keep all follow-up visits with your health care provider as scheduled. Call your health care provider between visits as needed, especially if you have concerns about symptoms.

Call your health care provider or get emergency help right away if you or a family member has any of the following symptoms, especially if they are new, worse, or worry you:

• suicide attempts
• acting aggressively, being angry, or violent
• new or worse depression
• panic attacks
• new or worse irritability
• an extreme increase in activity or talking (mania)
• thoughts about suicide or dying
• acting on dangerous impulses
• new or worse anxiety
• feeling very agitated or restless
• trouble sleeping
• other unusual changes in behavior or mood.

Common side effects

The most common side effects of doxepin capsules and oral solution are:

• Feeling overly sleepy
• Dry mouth
• Dizziness
• Constipation
• Tiredness

The most common side effects of doxepin tablets used to help sleep are:

• Drowsiness or tiredness
• Nausea
• Upper respiratory tract infection.

Serious side effects (doxepin capsules or oral solution)

Doxepin capsules and oral solution can cause the following other serious side effects.

Serotonin syndrome

Taking doxepin hydrochloride capsules can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when doxepin hydrochloride capsule is taken with certain other medicines (see What other drugs will affect doxepin? below).

Stop taking doxepin hydrochloride capsules and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

• Agitation
• Confusion
• Fast heartbeat
• Dizziness
• Flushing
• Shaking (tremors), stiff muscles, or twitching
• Seizures
• seeing or hearing things that are not real (hallucinations)
• Coma
• Changes in blood pressure
• Sweating
• High body temperature (hyperthermia)
• Loss of coordination
• Nausea, vomiting, diarrhea.

Eye problems (angle-closure glaucoma)

Doxepin hydrochloride capsules may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.

Manic episodes

Manic episodes may happen in people with bipolar disorder who take doxepin hydrochloride capsules. Symptoms may include:

• Greatly increased energy
• Racing thoughts
• Unusually grand ideas
• Talking more or faster than usual
• Severe trouble sleeping
• Reckless behavior
• Excessive happiness or irritability

Seizures (convulsions)

Doxepin capsules and oral solution used for depression may increase your risk of seizures.

Serious side effects (doxepin tablets, Silenor)

Doxepin tablets (generic, Silenor) can cause the following serious side effects.

Sleep-driving and Other Complex Behaviors

After taking doxepin tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with this medicine. Reported activities include:

• Driving a car ("sleep-driving")
• Making and eating food
• Talking on the phone
• Having sex
• Sleep-walking.

Call your healthcare provider right away if you find out that you have done any of the above activities after taking doxepin tablets.

Important:

• Take doxepin tablets exactly as prescribed. Do not take more than prescribed.
• Take doxepin tablets 30 minutes before bedtime. After taking doxepin, you should only do activities needed to get ready for bed.
• Do not take doxepin with alcohol
• If you take other medicines that can make you sleepy. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take doxepin with your other medicines
• Talk to your doctor if you cannot get a full night of sleep before you must be active again

Risk of suicide and worsening of depression

Doxepin is also used as an antidepressant at doses 10- to 100-fold higher than in doxepin tablets and Silenor.

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. Risk from the lower dose of doxepin used for sleep disorders can not be excluded. Call your healthcare provider right away if you have any thoughts of suicide, dying, or worsening depression.

Notes:

Doxepin may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of doxepin tablets. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The way doxepin works isn't fully understood, but it primarily works by blocking norepinephrine reuptake at nerve terminals, increasing norepinephrine activity at synapses. It also has anticholinergic, antiserotonin, and antihistamine effects.

Notably, doxepin is not a CNS stimulant or an MAOI, doesn't cause euphoria, and isn't associated with physical tolerance or psychological dependence typical of addictive compounds.

Doxepin belongs to the drug class called tricyclic antidepressants.

Doxepin capsules

If you miss a dose of doxepin hydrochloride capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, do not take the missed dose and take your next dose at the regular time. Do not take two doses of doxepin hydrochloride capsules at the same time.

Doxepin oral solution

If you miss a dose of doxepin hydrochloride, take the missed dose as soon as you remember. If it is almost time for the next dose, do not take the missed dose and take your next dose at the regular time. Do not take two doses of doxepin hydrochloride at the same time.

Doxepin tablets

If you miss a dose of doxepin tablets and fall asleep anyway. Do not take another dose. Doxepin tablets should only be taken within 30 minutes of bedtime.

Doxepin capsules

If you take too much doxepin hydrochloride capsules, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Doxepin oral solution

If you take too much doxepin oral solution, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Doxepin tablets

If you take too much doxepin, call your doctor or get medical help right away.

Do not drive a car or other motor vehicle, operate heavy machinery, or do dangerous activities while taking doxepin hydrochloride. Doxepin hydrochloride can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.

Do not drink alcohol during treatment with doxepin hydrochloride. Drinking alcohol during treatment with doxepin hydrochloride can increase your risk of having serious side effects.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Doxepin tablets and other medicines may affect each othe,r causing side effects. Doxepin may affect the way other medicines work, and other medicines may affects how it works. Especially tell your healthcare provider if you take:

Certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing

Medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)

• Medicines to treat migraine headaches, known as triptans
• Other tricyclic or tetracyclic antidepressants
• Opioids
• Lithium
• Tryptophan
• Buspirone
• St. John’s Wort
• Carbamazepine
• Cimetidine
• Tolazamide
• Medicines that can cause drowsiness

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take doxepin hydrochloride with your other medicines.

Do not start or stop any other medicines during treatment with doxepin hydrochloride without first talking to your healthcare provider.

Know the medicines you take. Keep a list of them to show to your healthcare providers when you start to take a new medicine.

Store doxepin at room temperature between 20°C and 25°C (68°F and 77°F).

Keep in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.

Keep out of the reach of children.

Active ingredient: doxepin hydrochloride

Inactive ingredients for Doxepin capsules (Alembic Pharmaceuticals Limited): colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The capsule shell contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 75 mg and 100 mg capsule shell also contains FD&C Blue 1. The capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac.

Inactive Ingredients for Doxepin Hydrochloride Oral Solution (Lannett Company): glycerin; methylparaben; peppermint flavor; propylparaben; water. May contain hydrochloric acid and/or sodium hydroxide.

Inactive Ingredients (Silenor tablets): Microcrystalline cellulose, colloidal silicon dioxide, colloidal anhydrous silica, light anhydrous silicic acid, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No. 1. The 6 mg tablet also contains FD&C Yellow No. 10 and FD&C Blue No. 1.

Inactive Ingredients for Doxepin Tablets (Strides Pharma): Colloidal silicon dioxide, crospovidone, microcrystalline cellulose, and magnesium stearate.