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Rozerem (ramelteon) is in a class of medications called hypnotics. It is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
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This information is intended to supplement, not substitute for,
the expertise and judgment of your physician, pharmacist or other health care provider.
It should not be construed to indicate that the use of the medication(s) shown are
safe, appropriate, or effective for you.
The information shown is general and does not cover all directions, possible drug integrations, or precautions.
Information on this site cannot be used for self-treatment and/or self-diagnosis.
Any specific instructions for a particular patient should be agreed with your health care provider.
We disclaim reliability of this information and mistakes it could contain.
We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of
the information on this site nor will we be held responsible for consequences of self-treatment.
Consult your health care provider before using any drug.
The following information is a summary about Rozerem.
It is not intended to replace a doctor's instructions.
Chemical Name: Ramelteon
General Information about Rozerem
Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). With the exception of Rozerem, all other prescription drugs indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Rozerem has a unique therapeutic mechanism of action that selectively targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates 24-hour, or circadian, rhythms including the sleep-wake cycle.
Before using Rozerem
Tell your doctor if you:
have liver disease
have sleep apnea
take fluvoxamine (Fluvox)
are depressed or have suicidal thoughts
You may not be able to take Rozerem, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
Rozerem is in the FDA pregnancy category C. This means that it is unknown whether Rozerem will harm an unborn baby. Do not take Rozerem without first talking to your doctor if you are pregnant.
It is unknown if Rozerem passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
If you are over 65 years of age, you may be more likely to experience side effects from Rozerem. You may require a lower dose of this medication.
Take Rozerem exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Take Rozerem within 30 minutes prior to going to bed and limit your activities to those necessary to prepare for bed.
You can take Rozerem with or without food but for Rozerem to work best, do not take it with or immediately after a high-fat, heavy meal.
Do not crush or chew the tablets. Take each tablet whole.
Take Rozerem only if you are able to get a full night's sleep (8 or more hours) before you must be active again.
Do not take more of this medication than is prescribed for you.
Store Rozerem at room temperature away from moisture and heat.
Use caution when driving, operating machinery, or performing other hazardous activities. Rozerem will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Rozerem should be taken just before bedtime. You may experience some carryover effects the next day.
Do not drink alcohol while taking Rozerem. Alcohol will increase drowsiness and may increase dizziness while you are taking Rozerem, which could be dangerous.
Avoid other sedatives, sleeping pills, and tranquilizers, including over-the-counter preparations. They should not be used while you are taking Rozerem unless your doctor directs otherwise.
Possible Rozerem side effects
If you experience any of the following serious side effects, stop taking Rozerem and seek emergency medical attention:
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, face, or tongue; hives)
Talk to your health care provider if you experience a worsening of insomnia or any new mental or physical problems that concern you.
Contact your health care provider if you experience any of the following:
decreased sex drive
excessive flow of milk from the breasts during nursing or milk flow from the breasts that is not associated with childbirth or the nursing of an infant in women
a loss of menses (period) in women
Contact your doctor if you experience:
daytime drowsiness, dizziness, or clumsiness
more outgoing or aggressive behavior than normal
memory loss problems
new feelings of depression
Side effects other than these may occur. If these become bothersome, contact your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Rozerem Interactions with Other Medications
Before taking Rozerem, tell your doctor if you are taking:
You may not be able to take Rozerem, or you may require a dosage adjustment or special monitoring during treatment.
Drugs other than those listed here may also interact with Rozerem or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
If you take too much Rozerem
Seek emergency medical attention.
Symptoms of a Rozerem overdose are unknown but may include extreme sleepiness, confusion, dizziness, difficult or slow breathing, and unconsciousness.
DO NOT SHARE THIS MEDICINE with others for whom it was not
prescribed. DO NOT USE THIS MEDICINE for other health conditions.
KEEP THIS MEDICINE out of the reach of children.