Ramelteon tablets

What is ramelteon?

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Unlike some other sleep medications, ramelteon is not known to be habit-forming.

Ramelteon may also be used for purposes not listed in this medication guide.

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

You should not use ramelteon if you are also taking fluvoxamine (Luvox), or if you have severe liver disease.

Ramelteon side effects

Get emergency medical help if you have signs of an allergic reaction: hives; nausea, vomiting; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity such as driving, eating, having sex, 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.

Stop using ramelteon and call your doctor at once if you have:

• unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;

• a missed menstrual period;

• nipple discharge; or

• loss of interest in sex.

Common side effects may include:

• drowsiness, tired feeling;

• dizziness;

• nausea; or

• worsening sleep problems.

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

Ramelteon will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

You should not use ramelteon if you are allergic to it, or if:

• you have severe liver disease; or

• you also take fluvoxamine (Luvox).

To make sure ramelteon is safe for you, tell your doctor if you have:

• liver disease;

• sleep apnea (breathing stops while you are asleep);

• a breathing disorder such as chronic obstructive pulmonary disease (COPD); or

• a history of depression, mental illness, or suicidal thoughts.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ramelteon passes into breast milk or if it could harm a nursing baby. Tell 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 a man or a woman.

Ramelteon is not approved for use by anyone younger than 18 years old.

How should I take ramelteon?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.

Do not crush, chew, or break the tablet. Swallow it whole.

Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Call your doctor if your symptoms do not improve after 7 to 10 days of using ramelteon.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Ramelteon dosing information

Usual Adult Dose for Insomnia:

8 mg orally within 30 minutes of going to bed

Maximum Dose: 8 mg per day

Comments: This drug should not be taken with or immediately after a high-fat meal.

Use: Treatment of insomnia characterized by difficulty with sleep onset

What happens if I miss a dose?

Since ramelteon is usually taken as needed, you may not be on a dosing schedule. Ramelteon should be taken only within 30 minutes of your normal bedtime. Do not take extra medicine to make up a missed dose.

What should I avoid while taking ramelteon?

Do not drink alcohol with this medicine.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect ramelteon?

Taking ramelteon with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• donepezil;

• doxepin;

• fluconazole;

• ketoconazole; or

• rifampin.