doxylamine (Aldex AN, Unisom)

Brand Names: Aldex AN, Unisom

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

What is doxylamine (Aldex AN, Unisom)?

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

Doxylamine is used to treat sneezing, itching, watery eyes, and runny nose caused by allergies or the common cold.

Doxylamine is also used as a short-term treatment for sleep problems (insomnia).

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

What are the possible side effects of doxylamine (Aldex AN, 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 or uneven heart rate;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

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; or
  • feeling restless or excited (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, Unisom)?

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Ask a doctor or pharmacist about taking this medication if you have liver or kidney disease, an enlarged prostate, problems with urination, a blockage in your stomach or intestines, or a chronic lung disease such as bronchitis or emphysema.

Do not use this medication to treat insomnia in a child younger than 12 years old. Ask a doctor before using this medication to treat cold or allergy symptoms in a child younger than 6 years old. Always ask a doctor before giving a cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of doxylamine.

What should I discuss with my health care provider before taking doxylamine (Aldex AN, Unisom)?

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

You should not use this medication if you are allergic to doxylamine, or if you have:

  • severe constipation;
  • a blockage in your digestive tract (stomach or intestines); or
  • if you are unable to urinate.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

  • liver or kidney disease;
  • an enlarged prostate;
  • problems with urination; or
  • bronchitis, emphysema, or other chronic lung disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Doxylamine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

How should I take doxylamine (Aldex AN, Unisom)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not use this medication to treat insomnia in a child younger than 12 years old. Ask a doctor before using this medication to treat cold or allergy symptoms in a child younger than 6 years old. Always ask a doctor before giving a cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take this medicine with food or milk if it upsets your stomach.

The chewable tablet must be chewed before you swallow it.

To treat insomnia, it is best to take doxylamine only when you can devote several hours to sleep. Follow your doctor's instructions.

Talk with your doctor if your cold or allergy symptoms do not improve after 7 days of treatment, or if your sleep problems do not improve after 2 weeks of treatment.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose (Aldex AN, Unisom)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

When treating insomnia, if it is almost your normal waking hour, skip the missed dose and wait until you are ready for bed again.

What happens if I overdose (Aldex AN, Unisom)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking doxylamine (Aldex AN, Unisom)?

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Doxylamine can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol can increase certain side effects of doxylamine.

What other drugs will affect doxylamine (Aldex AN, Unisom)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by doxylamine.

Ask a doctor or pharmacist if it is safe for you to use doxylamine if you are also using any of the following drugs:

This list is not complete and 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.

Where can I get more information?

Your pharmacist can provide more information about doxylamine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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