Doxylamine

What is Doxylamine?

• Doxylamine (Aldex AN; Nighttime Sleep Aid; Unisom SleepTabs) is a first generation antihistamine, used in the short-term treatment of insomnia.
• It is used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold.

Doxylamine structure

Doxylamine 3D ball

Doxylamine 3D spacefill

What are the uses of this medicine?

• Doxylamine (Aldex AN; Nighttime Sleep Aid; Unisom SleepTabs) is used to reduce difficulty in falling asleep (insomnia)
• Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold.

How does this medicine work?

• A pyridine derivate histamine H1 antagonist with pronounced sedative properties.
• Doxylamine succinate competitively blocks the histamine H1 receptor and limits the typical allergic and anaphylactic responses, including bronchoconstriction, vasodilation, increased capillary permeability, and spasmodic contraction of gastrointestinal smooth muscle, caused by actions of histamine on bronchial and gastrointestinal smooth muscles, and on capillaries.
• This drug also prevents histamine-induced pain and itching of the skin and mucous membranes.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• in children under 12 years of age.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• medications for colds, hay fever, or allergies
• medications for depression
• muscle relaxants
• narcotic medications for pain
• sedatives
• sleep medications
• tranquilizers

Is this medicine FDA approved?

• Doxylamine (dox il' a meen) is a first generation antihistamine that is used to treat the symptoms of allergic rhinitis and the common cold, including sneezing, cough, runny note, watery eyes and itching. Because of its sedating side effects, it is also used as a mild sleeping aid and sedative. Doxylamine belongs to the ethanolamine class of antihistamines (with clemastine and dimenhydrinate) and was approved for use in the United States in 1948. It is still widely used today, largely in combination with other agents such as dextromethorphan, pseudoephedrine, aspirin and acetaminophen in over-the-counter products for relief of symptoms of the common cold and allergic rhinitis.

How should this medicine be used?

Recommended dosage:

• Adults and children 12 years and over: Take one tablet (25mg) . 30 minutes before going to bed; take once daily or as directed by a doctor
• children under 12 years: Do not use.
• When doxylamine is used to treat cold symptoms, it is usually taken every 4 to 6 hours.

Administration:

• Doxylamine comes as a tablet to take by mouth for sleep, and in combination with other medications as a liquid and liquid-filled capsule to treat symptoms of the common cold.
• When doxylamine is used to reduce difficulty falling asleep, it usually is taken 30 minutes before bedtime.
• When doxylamine is used to treat cold symptoms, it is usually taken every 4 to 6 hours.
• Nonprescription cough and cold combination products, including products that contain doxylamine, can cause serious side effects or death in young children. Do not give nonprescription products that contain doxylamine to children younger than 4 years of age. Ask a doctor before giving these products to children 4 to 12 years of age.
• Cough and cold symptoms that get worse or that do not go away may be signs of a more serious condition.
• If you are taking doxylamine in combination with other medications to treat cough and cold symptoms, call your doctor if your symptoms worsen or if they last longer than 7 days.
• If you are taking doxylamine to treat insomnia, you will probably become very sleepy soon after you take the medication and will remain sleepy for some time after you take the medication.
• Plan to remain asleep for 7 to 8 hours after taking the medication.
• If you get up too soon after taking doxylamine, you may be drowsy.
• Doxylamine should only be used to treat insomnia for a short time.
• Call your doctor if you feel that you need to take doxylamine for longer than 2 weeks.
• If you are using the liquid, do not use a household spoon to measure your dose.
• Use the measuring cup or spoon that came with the medication or use a spoon that is made especially for measuring medication.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet and in combination with other medications as a liquid and liquid-filled capsule

This medicine is available in fallowing brand namesː

• Aldex AN; Nighttime Sleep Aid; Unisom SleepTabs

What side effects can this medication cause?

The most common side effects of this medicine include:

• sedation, impairment of motor function, confusion, dizziness, blurred vision, [[]]dry mouth and throat, palpitations, tachycardia, abdominal distress, constipation and headache.

• Antihistamines can worsen urinary retention and glaucoma.

Less common, but serious side effects may include:

• vision problems
• difficulty urinating

What special precautions should I follow?

Ask a doctor before use if you have:

• a breathing problem such as asthma, emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

• Alcohol can add to the drowsiness caused by this medication. Avoid alcoholic beverages while you are taking this medication.
• This medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking doxylamine.
• Older adults should not usually take doxylamine because it is not as safe or effective as other medications that can be used to treat the same condition.
• Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.
• If pregnant or breast-feeding, ask a health professional before use.
• Doxylamine has not been linked to instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking doxylamine, call your doctor.

Can this medicine be used in children?

• Do not use in children under 12 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DOXYLAMINE SUCCINATE

Inactive ingredients:

• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• FD&C BLUE NO. 1 ALUMINUM LAKE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• SODIUM STARCH GLYCOLATE TYPE A POTATO

Who manufactures and distributes this medicine?

• Chattem, Inc.

What should I know about storage and disposal of this medication?

• store at 68º to 77ºF (20º to 25ºC).
• retain in carton until time of use.

First Generation Antihistamines

• Brompheniramine
• Carbinoxamine
• Chlorcyclizine
• Chlorpheniramine
• Clemastine
• Cyclizine
• Cyproheptadine
• Dexbrompheniramine
• Dexchlorpheniramine
• Dimenhydrinate
• Diphenhydramine
• Doxylamine
• Hydroxyzine
• Meclizine
• Phenyltoloxamine
• Promethazine
• Triprolidine

Second Generation Antihistamines

• Acrivastine
• Cetirizine
• Fexofenadine
• Levocetirizine
• Loratadine
• Desloratadine

• Dailymed label info on Doxylamine
• FDA Doxylamine

Doxylamine Resources
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