Rozerem

The active ingredient in Rozerem is ramelteon, which is a melatonin receptor agonist. The mechanism of action is similar to melatonin, a naturally occurring hormone produced by your body when it is dark. This hormone signals your body to sleep to maintain a normal sleep-wake cycle.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Rozerem. However, the following is a synopsis of the general guidelines for the use of Rozerem:

• Take Rozerem 30 minutes before your regular bedtime.
• Swallow the tablet whole; do not chew, crush, or break it.
• Rozerem should not be taken alongside or following a high-fat meal. This reduces your body's ability to absorb the drug.
• If your symptoms persist after 7 to 10 days of using this medication, contact your doctor.
• If you drink alcohol, avoid taking this medication.

The most common side effects of ramelteon seen in clinical trials include:

• Drowsiness.
• Sleepiness.
• Fatigue.
• Nausea.
• Headaches.

Some individuals may experience serious side effects while using Rozerem. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction: swelling of the face, lips, tongue, or throat (angioedema), difficulty breathing, skin rash or hives.
• Suicidal thoughts or behaviour.
• Abnormal thinking, behavioral changes, complex behaviors, including sleep-driving, sleep walking, making phone calls, and hallucinations; immediately evaluate any new onset of behavioral changes.

These are not all of the possible adverse reactions of Rozerem. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Rozerem, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Severe liver disease.
• Take fluvoxamine.
• Breathing problems such as obstructive sleep apnea or chronic obstructive pulmonary disease (COPD).
• Worsening sleep problems.
• Worsening depression, mental illnesses, or suicidal thoughts. The risk or severity of CNS depression can be increased when Ramelteon is combined with 1,2-Benzodiazepine.
• Increased prolactin levels.
• Decreased testosterone levels.

• Taking fluvoxamine (luvox), a strong CYP1A2 enzyme inhibitor, concurrently with Rozerem.
• Hypersensitivity to ramelteon or any of the inactive ingredients in the product.

Rozerem begins to work within 30 minutes, as long as it is taken on an empty stomach. Food, particularly that high in fat content, can impede the body's ability to effectively absorb the medication, making Rozerem less effective.

When Rozerem is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Fluvoxamine.
• Fluconazole.
• Rifampin.
• Ketoconazole.
• Donepezil.
• Doxepin.
• Zolpidem.

The dosage form of Rozerem includes an 8 mg tablet.

Adults: The normal dose is 8 mg orally within 30 minutes of bedtime. Do not take Rozerem with or immediately after a high-fat meal.

Store at room temperature and keep out of reach of children.

Takeda Pharmaceuticals Inc. is the company that manufactures Rozerem.

There are several generic versions available of Rozerem.

Do not stop taking the medication abruptly. Rather, speak to your healthcare professional and see what is best.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

You should not breastfeed within 25 hours of using Rozerem. If you use a breast pump during this period, dispose of any milk you gather. Do not feed it to your infant. Infants exposed to Rozerem through breastmilk should be monitored for somnolence and feeding problems.