"Sleep disorder drugs (hypnotic and sedative drugs) overview
Insomnia, a disorder in which there is difficulty sleeping, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself "...
Rozerem Consumer (continued)
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.
Read the Rozerem (ramelteon) Side Effects Center for a complete guide to possible side effects
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.
Additional Rozerem Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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