Rozerem (ramelteon) is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your “sleep-wake cycle.”
Rozerem is used to treat insomnia that is associated with having trouble falling asleep.
Unlike some other sleep medications, Rozerem is not known to be habit-forming.
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Important information
Before taking Rozerem, tell your doctor if you have liver disease, sleep apnea, a breathing disorder such as chronic obstructive pulmonary disease, or a history of depression, mental illness, or suicidal thoughts.
You should not use ramelteon if you are also taking fluvoxamine (Luvox), or if you have severe liver disease.
You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).
Take Rozerem 30 minutes before your normal bedtime. After you take this medicine, avoid doing anything other than getting ready for bed.
Avoid taking Rozerem together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.
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 Rozerem and talk with your doctor about another treatment for your sleep disorder.
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Before taking this medicine
Rozerem 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 Rozerem if you are allergic to ramelteon, or if:
- you have severe liver disease; or
- you also take fluvoxamine (Luvox).
To make sure this medicine 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 Rozerem 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.
Rozerem is not approved for use by anyone younger than 18 years old.
How should I take Rozerem?
Take Rozerem exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take Rozerem 30 minutes before your normal bedtime. After you take this medicine, avoid doing anything other than getting ready for bed.
Do not crush, chew, or break the tablet. Swallow it whole.
Avoid taking Rozerem 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 Rozerem.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Rozerem 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 Rozerem is usually taken as needed, you may not be on a dosing schedule. This medicine should only be taken within 30 minutes of your normal bedtime. Do not take extra medicine to make up a missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Rozerem?
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.
Rozerem side effects
Get emergency medical help if you have signs of an allergic reaction to Rozerem: 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 Rozerem and talk with your doctor about another treatment for your sleep disorder.
Stop using this medicine 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 Rozerem side effects 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.
What other drugs will affect Rozerem?
Taking this dose 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.
This list is not complete. Other drugs may interact with ramelteon, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.