Simply Sleep

Name: Simply Sleep

Simply Sleep Overview

Simply Sleep is a brand name medication included in the following groups of medications: Aminoalkyl ethers, Antihistamines for topical use. For more information about Simply Sleep see its generic Diphenhydramine

What should I discuss with my healthcare provider before taking Simply Sleep (diphenhydramine)?

You should not use diphenhydramine if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

  • blockage in your digestive tract (stomach or intestines);

  • bladder obstruction or other urination problems;

  • a colostomy or ileostomy;

  • liver or kidney disease;

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;

  • cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

  • heart disease, low blood pressure;

  • glaucoma;

  • a thyroid disorder; or

  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether diphenhydramine will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

Diphenhydramine can pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Ask a doctor before using this medicine if you are breast-feeding.

Older adults may be more likely to have side effects from this medicine.

What should I avoid while taking Simply Sleep (diphenhydramine)?

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 diphenhydramine.

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 this type of medicine. Check the label to see if a medicine contains an antihistamine.

Simply Sleep (diphenhydramine) side effects

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

Stop using diphenhydramine and call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest;

  • painful or difficult urination;

  • little or no urinating;

  • confusion, feeling like you might pass out; or

  • tightness in your neck or jaw, uncontrollable movements of your tongue.

Common side effects may include:

  • dizziness, drowsiness, loss of coordination;

  • dry mouth, nose, or throat;

  • constipation, upset stomach;

  • dry eyes, blurred vision; or

  • day-time drowsiness or "hangover" feeling after night-time use.

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 are some things I need to know or do while I take Simply Sleep?

  • Tell all of your health care providers that you take Simply Sleep. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this medicine for longer than you were told by your doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Simply Sleep affects you.
  • Do not use with other products that have diphenhydramine.
  • Avoid drinking alcohol while taking this medicine.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • If you are 60 or older, use Simply Sleep with care. You could have more side effects.
  • Use with care in children. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Do not give to a child younger than 12 years of age.

How is this medicine (Simply Sleep) best taken?

Use Simply Sleep as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Take this medicine at bedtime.

What do I do if I miss a dose?

  • This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Change in balance.

What are some other side effects of Simply Sleep?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Dizziness.
  • Thickening of mucus in nose or throat.
  • Feeling nervous and excitable.
  • Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

In Summary

More frequent side effects include: sedation and thickening of bronchial secretions. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to diphenhydramine: compounding powder, injectable solution, oral capsule, oral disintegrating strip, oral liquid, oral tablet, oral tablet chewable, oral tablet disintegrating

General

The most commonly reported side effects included somnolence, dizziness, and incoordination.[Ref]

Nervous system

Common (1% to 10%): Sedation/somnolence/sleepiness, drowsiness, unsteadiness, dizziness, headache, attention disturbance
Rare (0.01% to 0.1%): Extrapyramidal effects, tremor, convulsions
Frequency not reported: Paresthesia, dyskinesia/muscle dyskinesia, vertigo, neuritis, incoordination, psychomotor impairment, activation of epileptogenic foci[Ref]

Drowsiness usually diminishes after a few days.[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth
Frequency not reported: Gastrointestinal disturbance, nausea, vomiting, constipation, diarrhea, dyspepsia, epigastric distress[Ref]

Other

Common (1% to 10%): Fatigue
Frequency not reported: Lassitude, tinnitus, acute labyrinthitis, asthenia, chills, impaired performance (including impaired driving, work, and/or information processing)[Ref]

Psychiatric

Rare (0.01% to 0.1%): Confusion, depression, sleep disturbances
Frequency not reported: Paradoxical excitation/excitation, agitation, increased energy, restlessness, nervousness, euphoria, anxiety, hallucinations, insomnia, irritability[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Palpitations, hypotension, arrhythmia
Frequency not reported: Tachycardia, chest tightness, extrasystoles[Ref]

Hematologic

Rare (0.01% to 0.1%): Blood disorders
Frequency not reported: Hemolytic anemia, thrombocytopenia, agranulocytosis[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions
Frequency not reported: Angioedema, anaphylactic shock[Ref]

Hepatic

Rare (0.01% to 0.1%): Liver dysfunction[Ref]

Dermatologic

Frequency not reported: Rash, urticaria, skin rashes, erythema, photosensitivity, pruritus, drug rash, excessive perspiration[Ref]

Respiratory

Frequency not reported: Dyspnea, thickening of bronchial secretions, throat tightening, wheezing, nasal stuffiness, dry nose or throat[Ref]

Genitourinary

Frequency not reported: Urinary hesitancy/difficulty/retention, dysuria, early menses[Ref]

Ocular

Frequency not reported: Blurred vision, dry eyes, diplopia[Ref]

Metabolic

Frequency not reported: Increased appetite, anorexia[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching/weakness[Ref]

Some side effects of Simply Sleep may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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