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Medications and Drugs

Brand Names: Aldex AN, Nytol Maximum Strength, Unisom

Generic Name: doxylamine (Pronunciation: dox IL a meen)

What is doxylamine (Aldex AN, Nytol Maximum Strength, Unisom)?

Doxylamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Doxylamine is sometimes combined with other medicines to treat sneezing, itching, watery eyes, and runny nose caused by allergies or the common cold.

Doxylamine as a single drug (not part of a combination) is used as a short-term treatment for sleep problems (insomnia).

Doxylamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of doxylamine (Aldex AN, Nytol Maximum Strength, Unisom)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • urinating less than usual or not at all;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

Less serious side effects may include:

  • blurred vision;
  • dry mouth;
  • nausea, stomach pain, constipation;
  • dizziness, drowsiness;
  • problems with memory or concentration;
  • ringing in your ears;
  • restless or excitability (especially in children);

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about doxylamine (Aldex AN, Nytol Maximum Strength, Unisom)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Ask a doctor or pharmacist about taking this medication if you have glaucoma, kidney disease, an enlarged prostate, problems with urination, a stomach ulcer or obstruction, or a chronic lung disease such as bronchitis or emphysema.

If you miss a dose, take it as soon as you remember. It is best to take doxylamine only when you can devote several hours to sleep. If it is almost your normal waking hour, skip the missed dose and wait until you are ready for bed again. Do not use extra medicine to make up the missed dose.

There may be other drugs that can interact with doxylamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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