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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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

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.