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 DEA. With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years. |
|
ACTIVE INGREDIENT: Ramelteon (ram-EL-tee-on)
COMMON BRAND NAME(S): Rozerem
HOW TO USE: Take Rozerem by mouth within 30 minutes of going to bed. Do not take Rozerem with or right after a high fat meal.
USES: Rozerem is a prescription medicine for adults to treat insomnia where the problem is trouble falling asleep. Rozerem has not been studied in children. It is not known if Rozerem is safe and effective for children.
SIDE EFFECTS: The following are the major potential risks and side effects of Rozerem therapy. However, this list is not complete. The following are the major potential risks and side effects of Rozerem therapy: Worsening of insomnia, mental, or behavior changes. These may happen if your insomnia is caused by a mental or medical problem. Your healthcare professional should check you carefully for other health problems before prescribing Rozerem. Tell your healthcare professional if you develop: worse insomnia mental problems including thoughts of harming yourself behavior changes Drowsiness. Rozerem may affect your ability to drive or do other dangerous activities. Do not do these activities after taking Rozerem. After taking Rozerem, do only activities needed to get ready for bed. Affect reproductive hormones. Rozerem may affect the reproductive hormones by increasing prolactin and potentially decreasing testosterone levels. This may cause missed monthly periods, nipple drainage, decreased sex drive, or problems getting pregnant. Your healthcare professional may do blood tests to check your hormone levels if you have any of these symptoms. Some common side effects that may occur with Rozerem include:
- headache
- daytime sleepiness
- dizziness
- tiredness
- nausea
- worsening insomnia
- colds
PRECAUTIONS: You should not take Rozerem if you have any of the following conditions: are allergic to ramelteon or any of its ingredients have severe liver disease. Before you start taking Rozerem, tell your healthcare professional if you: have or had liver disease. have breathing problems when you sleep (severe sleep apnea) or a lung disease called severe chronic obstructive pulmonary disease (COPD). Rozerem is not recommended if you have these problems.
DRUG INTERACTIONS: Rozerem and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Rozerem works or Rozerem may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional. Especially, tell your healthcare professional if you take:
- fluvoxamine
- rifampin (Rifadin)
- ketoconazole (Nizoral)
- fluconazole (Diflucan)
Tell your healthcare provider if you drink alcohol. Alcohol may increase the side effects with Rozerem.
OVERDOSE: Seek emergency medical attention. Symptoms of a Rozerem overdose are unknown but may include extreme sleepiness, confusion, dizziness, difficult or slow breathing, and unconsciousness.
NOTES: Use caution when driving, operating machinery, or performing other hazardous activities. Remeron may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities. Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall. Avoid the use of alcohol while taking Remeron. Alcohol may increase drowsiness and dizziness.
MISSED DOSE: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
STORAGE: Keep out of the reach of children. Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.
|
IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.
|
|