Pronunciation:

ram-EL-tee-on

Brand Names:

• Rozerem

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Nonbarbiturate Hypnotic

Pharmacologic—

Melatonin Receptor Agonist

Uses of This Medicine:

Ramelteon belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Ramelteon is used to treat insomnia (trouble in sleeping). Ramelteon helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

This medicine is available only with your doctor's prescription

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ramelteon in children with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fluvoxamine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Mental depression or
• Sleep apnea (temporary stopping of breathing during sleep)—Ramelteon may make these conditions worse.

• Liver disease—Higher blood levels of ramelteon may result, increasing the chance of side effects.

Proper Use of This Medicine:

Take ramelteon just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

Take ramelteon on an empty stomach.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For the treatment of insomnia (trouble in sleeping):
    • Adults—8 milligrams (mg) at bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Insomnia that lasts following a reasonable period of treatment may be a sign of another medical problem that should be evaluated. Consult your doctor if new or worsening signs of insomnia occur.

Avoid drinking alcohol while using this medicine. Ramelteon will add to the effects of alcohol.

If you develop any unusual and strange thoughts or behavior while you are taking ramelteon, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

If cessation of menstrual cycle (females), decreased libido, or problems with fertility occur, be sure to discuss it with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dizziness

sleepiness or unusual drowsiness

Less common

Body aches or pain

change in taste

chills

cough

difficulty in breathing

difficulty in moving

discouragement

ear congestion

fatigue

feeling sad or empty

fever

general feeling of discomfort or illness

irritability

joint pain

loss of appetite

loss of interest or pleasure

loss of taste

loss of voice

muscle aching or cramping

muscle pain or stiffness

nasal congestion

nausea

pain in joints

runny nose

shivering

sleeplessness

sneezing

sore throat

sweating

swollen joints

trouble concentrating

trouble sleeping

unable to sleep

unusual tiredness or weakness

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.