Rozerem

DRUG DESCRIPTION

ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1, 6, 7, 8tetrahydro-2H-indeno-[5, 4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure:

ROZEREM (ramelteon) Structural Formula Illustration

Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11.

Each ROZEREM (ramelteon) tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black.

What are the possible side effects of ramelteon (Rozerem)?

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 ramelteon and talk with your doctor about another treatment for your sleep disorder.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ramelteon and call your doctor at once if you have a serious side effect such as:

    ...

Read All Potential Side Effects and See Pictures of Rozerem

What are the precautions when taking ramelteon (Rozerem)?

Before taking ramelteon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (bronchitis, emphysema, sleep apnea), liver disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely....

Read All Potential Precautions of Rozerem


Rozerem Consumer (continued)

SIDE EFFECTS: Dizziness, tiredness, or daytime drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people who take sleep medications have reported getting out of bed and sleep-walking, driving, eating, talking on the phone, or doing other activities while not fully awake. Often, they have no memory of these activities. This problem can be dangerous to you or others. If you have or think you have this problem, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual desire, missed menstrual periods, nipple discharge, difficulty becoming pregnant.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., depression, strange thoughts, thoughts of suicide).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ramelteon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (bronchitis, emphysema, sleep apnea), liver disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages because they may increase the risk of this drug's side effects and can worsen sleeping problems.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.


Rozerem Patient Information Including Side Effects

Brand Names: Rozerem

Generic Name: ramelteon (Pronunciation: ram EL tee on)

  • What is ramelteon (Rozerem)?
  • What are the possible side effects of ramelteon (Rozerem)?
  • What is the most important information I should know about ramelteon (Rozerem)?
  • What should I discuss with my healthcare provider before taking ramelteon (Rozerem)?
  • How should I take ramelteon (Rozerem)?
  • What happens if I miss a dose (Rozerem)?
  • What happens if I overdose (Rozerem)?
  • What should I avoid while taking ramelteon (Rozerem)?
  • What other drugs will affect ramelteon (Rozerem)?
  • Where can I get more information?

What is ramelteon (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."

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Unlike some other sleep medications, ramelteon is not known to be habit-forming.

Ramelteon may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ramelteon (Rozerem)?

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 ramelteon and talk with your doctor about another treatment for your sleep disorder.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ramelteon and call your doctor at once if you have a serious side effect such as:

  • unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;
  • a missed menstrual period;
  • nipple discharge; or
  • loss of interest in sex.

Less serious side effects may include:

  • drowsiness;
  • dizziness;
  • headache; or
  • nausea.

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 is the most important information I should know about ramelteon (Rozerem)?

Do not use this medication if you are allergic to ramelteon, or if you have severe liver disease.

You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

Before taking ramelteon, 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.

Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.

Avoid taking ramelteon 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 ramelteon and talk with your doctor about another treatment for your sleep disorder.

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