ramelteon - [Medication]

ramelteon

Pronunciation:	ram EL tee on
Brand:	Rozerem

What is the most important information I should know about ramelteon?

Ramelteon may cause a severe allergic reaction. Stop taking ramelteon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Ramelteon will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and talk with your doctor about another treatment for your sleep disorder.

Ramelteon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not drink alcohol while you are taking ramelteon. It can increase some of the side effects of ramelteon, including drowsiness.

Ramelteon may be habit-forming and should be used only by the person it was prescribed for. Ramelteon should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms if you stop taking ramelteon after taking it over several days in a row. Do not stop taking ramelteon suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

What is ramelteon?

Ramelteon is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Ramelteon is used to treat insomnia. This medication causes relaxation to help you fall asleep and stay asleep.

Ramelteon may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking ramelteon?

Ramelteon will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Do not use this medication if you are allergic to ramelteon.

Before taking ramelteon, tell your doctor if you are allergic to any drugs, or if you have:

liver disease;
sleep apnea (breathing stops while you are asleep);
lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary pulmonary disease (COPD);
a history of depression, mental illness, or suicidal thoughts; or
a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use ramelteon, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not know whether ramelteon passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either men or women.

The sedative effects of ramelteon may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking ramelteon.

How should I take ramelteon?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take ramelteon only if you are able to get a full night's sleep before you must be active again. Never take this medication during your normal waking hours, unless you have a full 7 to 8 to dedicate to sleeping.

Take ramelteon with a full glass of water.

Avoid taking ramelteon within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.

Ramelteon is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take ramelteon for longer than 2 weeks without your doctor's advice.

Store ramelteon at room temperature away from moisture and heat.

Keep track of how many capsules have been used from each new bottle of this medicine. Ramelteon is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since ramelteon is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have a full 7 to 8 to sleep before being active again. Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a ramelteon are not known.

What should I avoid while taking ramelteon?

Do not drink alcohol while you are taking ramelteon. It can increase some of the side effects of ramelteon, including drowsiness.

Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

What are the possible side effects of ramelteon?

Stop using ramelteon and call your doctor at once if you have any of these serious side effects:

aggression, agitation, changes in behavior;
thoughts of hurting yourself;
hallucinations (hearing or seeing things); or
changes in menstrual periods, discharge from the nipples.

Keep taking the medication and talk with your doctor if you have any of these less serious side effects:

day-time drowsiness, dizziness, "hangover" feeling;
depression;
headache;
nausea, constipation;
unusual or unpleasant taste in your mouth; or
joint or muscle pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect ramelteon?

Before taking ramelteon, tell your doctor if you are taking any of the following drugs:

cimetidine (Tagamet);
fluvoxamine (Luvox);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
antibiotics such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral); or
narcotic pain medications, muscle relaxers, seizure medications, or anti-anxiety medications.

If you are using any of these drugs, you may not be able to use ramelteon, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect ramelteon. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about ramelteon written for health professionals that you may read.

What does my medication look like?

Ramelteon is available with a prescription under the brand name Rozerem. Other brand or generic formulations of this medication may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Rozerem 8mg-- as round, pale orange-yellow, film-coated.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 1.03. Revision date: 04/25/2007.

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