Ramelteon

U.S. Brand Names

Rozerem™

Pharmacologic Category

Hypnotic, Nonbenzodiazepine

Reasons not to take this medicine

• If you have an allergy to ramelteon or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have severe liver disease.

• If you are taking fluvoxamine.

What is this medicine used for?

• This medicine is used to treat sleep disorders.

How does it work?

• Ramelteon calms the brain.

How is it best taken?

• Take this medicine 30 minutes before bedtime.

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

• Avoid taking this medicine with high-fat meals.

What do I do if I miss a dose? (does not apply to patients in the hospital)

• Many times this medicine is taken on an as needed basis. Do not take more often than every 24 hours, unless instructed by healthcare provider.

What are the precautions when taking this medicine?

• If you have liver disease, talk with healthcare provider.

• If you have lung disease, you may be more sensitive to this medicine.

• If you have mental illness, talk with healthcare provider.

• If you wake up in the early morning, this medicine will not help.

• Do not nap.

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• You may not be alert. Avoid driving, doing other tasks or activities until you see how this medicine affects you.

• Avoid alcohol (includes wine, beer, and liquor) or other medicines and natural products that slow your actions and reactions. These include sedatives, tranquilizers, mood stabilizers, antihistamines, and other pain medicine.

• Tell healthcare provider if you are pregnant or plan on getting pregnant.

• Tell healthcare provider if you are breast-feeding.

What are some possible side effects of this medicine?

• Feeling lightheaded, sleepy, having blurred vision, or a change in thinking clearly. Avoid driving, doing other tasks or activities that require you to be alert or have clear vision until you see how this medicine affects you.

• Feeling tired or weak.

• Change in balance.

• Headache.

• For females, menstrual changes. These include lots of bleeding, spotting, or bleeding between cycles.

• Change in sexual ability or desire. This is usually reversible.

• Severe allergic reactions can rarely occur.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

Reasons to call healthcare provider immediately

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.

• Signs or symptoms of depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.

• Significant change in thinking clearly and logically.

• Driving or doing other tasks or activities that you do not remember doing after taking this medicine.

• Any rash.

• No improvement in condition or feeling worse.

How should I store this medicine?

• Store at room temperature.

• Protect from moisture. Do not store in a bathroom or kitchen.

General statements

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

Created: 2006-10-13 15:30:47.0

Modified: 2008-01-28 15:11:46.0

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