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|Simply Sleep

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 other similar medicines
• you are taking sodium oxybate (GHB)
• you are taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the past 2 weeks
• you are breast-feeding

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

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; 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
• MAO inhibitors (eg, phenelzine) because they can cause serious, sometimes fatal, reactions. Do NOT take MAO inhibitors within 2 weeks of taking Simply Sleep

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.

• Simply Sleep may be taken 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. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Simply Sleep . Using Simply Sleep alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Simply Sleep . Simply Sleep will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Alcohol, hot weather, exercise, and fever can increase the risk of dizziness, lightheadedness, or fainting. To prevent these effects, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Do not become overheated in hot weather or during exercise or other activities because heatstroke may occur.
• Simply Sleep may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Simply Sleep . Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Simply Sleep contains diphenhydramine. Before you begin taking any new prescription or over-the-counter medicine including one used on the skin, read the ingredients to see if it also contains diphenhydramine. If it does or if you are uncertain, contact 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 because they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.
• Simply Sleep is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Simply Sleep during pregnancy. Simply Sleep is excreted 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.

Severe allergic reactions (rash; hives; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

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.

This information is a summary only. It does not contain all information about Simply Sleep . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.