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; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.
Some people using  ramelteon have engaged in activity while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.
Before taking this medicine
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.
Tell your doctor if you have ever had:
liver disease;
breathing problems;
sleep apnea (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 out any milk you collect. Do not feed it to your 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 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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
