Ramelteon

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

Ramelteon is used to treat insomnia that is related to difficulty falling asleep.

Ramelteon may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take ramelteon 30 minutes before your normal bedtime.

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

Ramelteon should not be taken with or after 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.

You should not use ramelteon if you are also taking fluvoxamine, or if you have ever had a severe allergic reaction to ramelteon.

Ramelteon may cause a severe allergic reaction. Get emergency medical help if you have hives; difficulty breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have done activities while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.

Ramelteon will help you fall asleep. Never take ramelteon during your normal waking hours unless you have at least 7 to 8 hours to sleep.

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

• you have severe liver disease; or
• you also take fluvoxamine.

Tell your doctor if you have ever had:

• liver disease;
• breathing problems;
• sleep apnea (when breathing stops while you are asleep); or
• depression, mental illness, or suicidal thoughts.

Tell your doctor if you are pregnant or breastfeeding.

You should not breastfeed within 25 hours after using ramelteon. If you use a breast pump during this time, throw away any milk you collect. Do not give it to your baby.

Ramelteon may change 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.

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

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

Some people using ramelteon have engaged in activities while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Ramelteon may cause serious side effects. 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 of ramelteon may include:

• drowsiness, tired feeling;
• dizziness;
• nausea; or
• worsening sleep problems.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Insomnia:

8 mg orally within 30 minutes of going to bedMaximum Dose: 8 mg per dayComments: This drug should not be taken with or immediately after a high-fat meal.Use: Treatment of insomnia characterized by difficulty with sleep onset

Since ramelteon is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medication if you do not have 7 to 8 hours to sleep before being active again.

Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol with ramelteon.

Avoid driving or doing anything dangerous until you understand how this medicine will affect you. Your reactions could be impaired.

Using ramelteon with other drugs that make you sleepy can make you even sleepier. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of other drugs are in your blood, which may increase side effects or reduce how well the medications work.

Other drugs may affect ramelteon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you are currently taking and any new medicine you start or stop using.