Rozerem
ramelteon (ram L tee on)


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

• Use caution when driving, operating machinery, or performing other hazardous activities. Rozerem will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Rozerem should be taken just before bedtime. You may experience some carryover effects the next day.

• Take Rozerem within 30 minutes prior to going to bed and limit your activities to those necessary to prepare for bed.

• Do not take Rozerem with or immediately after a high fat meal.

• Talk to your health care provider if you experience a worsening of insomnia or any new mental or physical problems that concern you.

• Contact your health care provider if you experience any of the following:

· decreased sex drive;

· excessive flow of milk from the breasts during nursing or milk flow from the breasts that is not associated with childbirth or the nursing of an infant in women;

· a loss of menses (period) in women; or

· fertility problems.


What is Rozerem?

• Rozerem is in a class of drugs called sleep medications. Rozerem affects chemicals in your brain that may affect sleep.

• Rozerem induces sleep and causes relaxation. It is used to treat insomnia.

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


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

• Before taking this medication, tell your doctor if you

· have liver disease;

· have sleep apnea;

· take fluvoxamine (Fluvox);

· are depressed or have suicidal thoughts.

• You may not be able to take Rozerem, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

• Rozerem is in the FDA pregnancy category C. This means that it is unknown whether Rozerem will harm an unborn baby. Do not take Rozerem without first talking to your doctor if you are pregnant.

• It is unknown if Rozerem passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

• If you are over 65 years of age, you may be more likely to experience side effects from Rozerem. You may require a lower dose of this medication.


How should I take Rozerem?

• Take Rozerem exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

• Take each dose with a full glass of water.

• Take Rozerem within 30 minutes prior to going to bed and limit your activities to those necessary to prepare for bed.

• You can take Rozerem with or without food but for Rozerem to work best, do not take it with or immediately after a high-fat, heavy meal.

• Do not crush or chew the tablets. Take each tablet whole.

• Take Rozerem only if you are able to get a full night's sleep (8 or more hours) before you must be active again.

• Do not take more of this medication than is prescribed for you.

• Store Rozerem at room temperature away from moisture and heat.


What happens if I miss a dose?

• Since Rozerem is usually taken only if you need it to help you sleep, missing a dose will not cause any problems.


What happens if I overdose?

• Seek emergency medical attention.

• Symptoms of a Rozerem overdose are unknown but may include extreme sleepiness, confusion, dizziness, difficult or slow breathing, and unconsciousness.


What should I avoid while taking Rozerem?

• Use caution when driving, operating machinery, or performing other hazardous activities. Rozerem will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Rozerem should be taken just before bedtime. You may experience some carryover effects the next day.

• Do not drink alcohol while taking Rozerem. Alcohol will increase drowsiness and may increase dizziness while you are taking Rozerem, which could be dangerous.

• Avoid other sedatives, sleeping pills, and tranquilizers, including over-the-counter preparations. They should not be used while you are taking Rozerem unless your doctor directs otherwise.


What are the possible side effects of Rozerem?

• If you experience any of the following serious side effects, stop taking Rozerem and seek emergency medical attention:

· an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, face, or tongue; hives).

• Talk to your health care provider if you experience a worsening of insomnia or any new mental or physical problems that concern you.

• Contact your health care provider if you experience any of the following:

· decreased sex drive;

· excessive flow of milk from the breasts during nursing or milk flow from the breasts that is not associated with childbirth or the nursing of an infant in women;

· a loss of menses (period) in women; or

· fertility problems.

• Contact your doctor if you experience

· daytime drowsiness, dizziness, or clumsiness;

· more outgoing or aggressive behavior than normal;

· confusion;

· strange behavior;

· memory loss problems;

· agitation;

· hallucinations; or

· new feelings of depression.

• Side effects other than these may occur. If these become bothersome, contact your doctor.

• 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 Rozerem?

• Before taking Rozerem, tell your doctor if you are taking

· fluvoxamine (Fluvox);

· rifampin (Rifadin);

· ketoconazole (Nizoral); or

· fluconazole (Diflucan).

• You may not be able to take Rozerem, or you may require a dosage adjustment or special monitoring during treatment.

• Drugs other than those listed here may also interact with Rozerem or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.


Where can I get more information?

• Your pharmacist has additional information about Rozerem written for health professionals that you may read.

• 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.