Simply Sleep

Generic Name: diphenhydramine (DYE-fen-HYE-dra-meen)
Brand Name: Examples include Nytol and Simply Sleep

Simply Sleep is used for:

Treating occasional sleeplessness and reducing difficulty falling asleep.

Simply Sleep is an antihistamine. It works by depressing the central nervous system (brain) to produce drowsiness.

Do NOT use Simply Sleep if:

  • you are allergic to any ingredient in Simply Sleep or to other similar medicines
  • you are taking sodium oxybate (GHB)
  • you are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Simply Sleep:

Some medical conditions may interact with Simply Sleep. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung disease, shortness of breath, or sleep apnea
  • if you have blockage of the stomach, intestine, or urinary tract; difficulty urinating; diabetes; ulcers; enlargement of the prostate; glaucoma; heart disease; high blood pressure; the blood disease porphyria; or thyroid disease

Some MEDICINES MAY INTERACT with Simply Sleep. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Simply Sleep may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Simply Sleep:

Use Simply Sleep as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Simply Sleep by mouth with or without food.
  • Use Simply Sleep exactly as directed on the package, unless instructed differently by your doctor.
  • Take at least 30 minutes before bedtime to help fall asleep.
  • If you miss a dose of Simply Sleep and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Simply Sleep.

Important safety information:

  • Simply Sleep may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Simply Sleep with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Simply Sleep; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Simply Sleep may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Simply Sleep may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Simply Sleep. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Simply Sleep has diphenhydramine in it. Before you start any new medicine, check the label to see if it has diphenhydramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • If sleeplessness persists for more than 2 weeks, contact your health care provider.
  • Use Simply Sleep with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.
  • Simply Sleep should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Simply Sleep while you are pregnant. Simply Sleep is found in breast milk. Do not breast-feed while taking Simply Sleep.

Possible side effects of Simply Sleep:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth, throat, and nose; thickening of mucus in nose or throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; decreased alertness; excitability; fast heartbeat; hallucinations; tightness or pounding in the chest; tremor; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.

Proper storage of Simply Sleep:

Store Simply Sleep at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), or according to directions on the package label. Store in the original package or container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Simply Sleep out of the reach of children and away from pets.

General information:

  • If you have any questions about Simply Sleep, please talk with your doctor, pharmacist, or other health care provider.
  • Simply Sleep is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Simply Sleep or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Simply Sleep. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Simply Sleep. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Simply Sleep.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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