This medicine contains ramelteon as active ingredient. It is an psychoactive drug that has a specific effect on certain areas of the brain. This medicine is a unique hypnotic that activates the same nerve endings that are acted on by melatonin, the hormone that is essential to natural sleep and our normal circadian rhythms that dictate sleep-wake patterns.
This medicine is prescribed for sleeping disorders characterized by difficulty falling asleep.
Difficulty sleeping may be a sign of another physical or psychological problem. If this medicine does not help, ask your doctor to look for other issues that might be interfering with your sleep and have not yet been discovered.
Before using this medicine
Before you use this medicine check with your doctor, or pharmacist:
• if you ever had any unusual or allergic reaction to this medicine or any psychoactive drug;
• if you are allergic to any medicines, foods or other substances;
• if you are pregnant or intend to become pregnant while using this medicine (animal studies have shown toxic effects to developing fetuses);
• if you are breast-feeding an infant;
• if you have kidney or liver disease.
The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regime. The recommended starting dose for adults is 8 mg taken 30 minutes before sleep. The medicine is not recommended for children.
Studies have shown that the medicine has no potential for abuse and is not considered a controlled substance under federal laws. Studies of up to 20 times the recommended dosage showed no indication of abuse potential with this medicine. The drug passes rapidly into the blood and starts working in a few minutes. It is broken down in the liver and mostly passes out of the body in the urine.
Seniors retain almost twice as much of this medicine as younger adults and should use the lowest effective dose.
Warnings and Cautions
• Complex sleep-related behaviors including driving, eating, and walking while asleep, with no memory of the event afterward, can occur with this medicine and other sleep medications. These activities happen after taking a sedative-hypnotic product while you are not fully awake.
• People with severe liver disease should not take this drug. Even those with mild liver disease can have as much as 4 times as much medicine in their blood as those with normal liver function.
• The medicine does not cause difficulty breathing. However, people with chronic obstructive pulmonary disease and other respiratory conditions have not yet been studied with this drug.
• In depressed patients taking any hypnotic drug, worsening depression, including suicidal thoughts, is possible.
Along with the needed effects, a medicine may cause some unwanted effects. Possible side effects include:
Upper respiratory infections
Driving or Hazardous Work
Do not drive until you learn how the medicine affects you. Do not work around dangerous machinery. Do not climb ladders or work in high places. Danger increases if you drink alcohol or take medicines affecting alertness and reflexes.
• Fluvoxamine can dramatically increase the amount of this medicine in the blood by interfering with enzymes in the liver that break it down.
• Ketoconazole and fluconazole increase the amount of this medicine in the blood by affecting the breakdown in the liver. The combination should be used with caution.
• Alcohol can increase the effects of this medicine. Avoid alcoholic beverages before you take this medicine or during the 30 minutes between taking this medicine and going to sleep.
There have been no reports of overdose of this medicine, although symptoms are likely to be sleepiness and some of the side effects. Overdose victims would be taken to a hospital emergency room at once.
The tablets should be stored at room temperature. Keep out of reach of children, since this medicine may be dangerous to children.