Drugs Q & A

Has Doxepin (Sinequan) Been Discontinued?

What is Doxepin?

Doxepin more commonly known by the brand name Sinequan is a medication used to treat depression and anxiety. Doxepin is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed for mental balance.

Depression and anxiety are different conditions, but they commonly occur together. They also have similar treatments. Feeling down or having the blues now and then is normal. And everyone feels anxious from time to time — it’s a normal response to stressful situations. But severe or ongoing feelings of depression and anxiety can be a sign of an underlying mental health disorder.

Anxiety may occur as a symptom of clinical (major) depression. It’s also common to have depression that’s triggered by an anxiety disorder, such as generalized anxiety disorder, panic disorder or separation anxiety disorder. Many people have a diagnosis of both an anxiety disorder and clinical depression.

How should Doxepin be used?

Doxepin comes as a capsule, or concentrate (liquid) to take by mouth. It is usually taken one to three times a day and may be taken with or without food. Try to take doxepin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take doxepin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Doxepin concentrate (oral liquid) comes with a specially marked dropper for measuring the dose. Ask your pharmacist to show you how to use the dropper. Dilute the concentrate in 4 ounces (120 mL) of water; whole or skim milk; or orange, grapefruit, tomato, prune, or pineapple juice just before taking it. Do not mix it with carbonated beverages (soft drinks).

It may take several weeks or longer for you to feel the full effect of doxepin. Continue to take doxepin even if you feel well. Do not stop taking doxepin without talking to your doctor. Your doctor will probably want to decrease your dose gradually.

why is doxepin discontinued

Has Doxepin (Sinequan) Been Discontinued?

No, Pfizer has not discontinued doxepin (Sinequan). Doxepin is still available on the market and is approved by the U.S. Food and Drug Administration (FDA) for the treatment of depression, anxiety, and insomnia.

However, it is worth noting that some formulations of doxepin have been discontinued. For example, in 2010, the FDA approved a low-dose formulation of doxepin (3mg and 6mg) under the brand name Silenor for the treatment of insomnia. This formulation is still available on the market, but higher doses of doxepin (such as the 10mg, 25mg, 50mg, and 100mg capsules of Sinequan) are no longer manufactured by the manufacturer (Pfizer) most likely because it became an uneconomically viable product line for its manufacturer and was discontinued for business reasons. Mylan, pharmaceuticals the supplier of another brand of doxepin hydrochloride capsules known as Anten has also notified regulators of the discontinuation of the product since 2019.

It is unclear why some companies have discontinued higher doses of doxepin, but it may be due to the availability of newer medications with better safety profiles and fewer side effects. Additionally, there may have been a decrease in demand for doxepin due to the availability of alternative medications or changes in prescribing practices.

Nevertheless, doxepin oral capsule is still available as a generic drug in the U.S. Doxepin comes in three oral forms: capsule, tablet, and solution. It also comes as a cream.

What are the likely side effects of using Doxepin o treat depression and anxiety?

Some of the more common side effects that can occur with use of doxepin include:

  • drowsiness
  • dizziness
  • dry mouth
  • blurred vision
  • constipation
  • trouble urinating
  • nausea or vomiting
  • upset stomach
  • changes in how foods taste
  • weight gain

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Suicidal thoughts and behaviors and worsening depression. Symptoms can include:
    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worsened symptoms of anxiety
    • feeling very agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worsened irritability
    • acting aggressive, angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • other unusual changes in your behavior or mood
  • Urinary retention (problems urinating). Symptoms include:
    • not being able to empty your bladder
    • painful or urgent need to urinate
    • pain or bloating in your lower belly
    • feeling like you cannot completely empty your bladder when you urinate

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Doxepin may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication. You can find useful information on Doxepin Vs Xanax: Differences Similarities, Which is Stronger

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