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Ramelteon FDA Approved Insomnia Treatment

People with sleep-onset insomnia who struggle to fall asleep are prescribed ramelteon. A pharmaceutical substance known as ramelteon is categorized as a selective agonist of the MT1 and MT2 melatonin receptors.

Ramelteon, also marketed under the name Rozerem, is a melatonin receptor agonist that mimics the physiological effects of endogenous melatonin.

Melatonin is secreted by the human body during periods of darkness in order to keep the sleep-wake cycle regular. Ramelteon is a pharmaceutical substance that has qualities similar to melatonin and is used to accelerate the onset of sleep.

Why do doctors advise using Ramelteon to treat insomnia?

When someone has sleep-onset insomnia and finds it difficult to fall asleep, ramelteon is frequently prescribed. Ramelteon is categorized as a pharmacological class member of melatonin receptor agonists. Similar to the brains natural melatonin production, which is essential for promoting sleep, it functions similarly.

The features and attributes of the product are elaborately explained in the following.

What is the suggested Ramelteon Insomnia Treatment?

Tablets containing the oral version of Ramelteon are available for purchase. It is recommended to give one dose every day, at least half an hour before the intended bedtime. It is best to avoid taking Ramelteon right before or right after eating.

For clarification on any directions on your prescription label that you are unsure of how to follow or find confusing, it is best to speak with your pharmacist or healthcare provider.

Ramelteon should be taken according to the recommended dosing schedule. It is critical that you follow your doctors instructions on the dosage and administration frequency exactly.

It is advised to refrain from masticating, fracturing, or pulverizing the tablets instead, they should be ingested.

Ramelteon Daily Doses for Insomnia

After taking Ramelteon, people could feel tired in a short amount of time. It is recommended that you make all of the required preparations for bed before taking a dose of Ramelteon. Please do not arrange for any other events to take place during this time.

If you are not able to set aside seven or eight hours of sleep per night, you should not use Ramelteon.

Safety of Ramelteon

Safety is a topic that is extremely important in many different contexts and disciplines. It includes the measurements.

There isnt any proof that Ramelteon is a serious risk to safety. After participating in the experiment for a full year, 3.1% of the patients experienced one or more significant adverse events. It is noteworthy, however, that less than 10% of these occurrences had a direct connection to the ramelteon medications administration.

It is recommended that patients with considerable hepatic impairment or those who are also taking fluvoxamine (Luvox), a medicine that is known to affect the metabolism of Ramelteon, refrain from using Ramelteon.

It has been observed that the administration of Ramelteon increases blood concentrations of either ketoconazole (Nizoral) or fluconazole (Diflucan), which may raise the risk of side events or poor therapeutic outcomes.

When alcohol and Ramelteon are taken together, the formers pharmacological effects are not significantly increased.

It is not recommended for use by children or adolescents because there hasnt been any explicit testing done on this age group. Ramelteon is not advised for use by nursing mothers.

The tolerability of Ramelteon term "tolerability" describes a persons or a groups capacity to bear something, and in general, people can tolerate Ramelteon well. In the clinical studies, the percentage of participant dropout for those receiving Ramelteon was 5%, whereas the rate for the placebo group was 2%.

Ramelteon does not appear to have any side effects that are often linked to symptoms that occur after taking medication.

Ramelteon treatment did not show any signs of rebound insomnia in 35-day clinical studies. Moreover, no withdrawal symptoms were noticed after the medicine was stopped.

Important Patient Information

RAMELTEON - ORAL (ra-MEL-tee-on) COMMON BRAND NAME(S): Rozerem

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

USES: This medication is used to treat sleeplessness (insomnia). It helps you fall asleep faster so you can get a full night's rest. Sleep is important for your ability to function, think clearly, and remain alert. Lack of sleep can cause problems such as depression, heart disease and accidents. Getting enough sleep allows your mind and body to repair itself and increases your energy throughout the day. Ramelteon works like a natural substance called melatonin that is produced by your body. It helps regulate your sleep-wake cycle (circadian rhythm).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ramelteon and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually 30 minutes before bedtime. Do not take ramelteon with or immediately after a high-fat meal because fat can affect how well this drug works. The manufacturer directs not to break the tablet before taking it. However, many similar drugs (immediate-release tablets) can be broken. Follow your doctor's directions on how to take this medication. Do not take a dose of this medication unless you have time for a full night's sleep that lasts at least 7 to 8 hours. Your dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more often than prescribed. Inform your doctor if you have any changes in mood (such as feelings of depression), if you continue to have trouble falling asleep, or if your insomnia worsens.

SIDE EFFECTS: Dizziness, tiredness, or daytime drowsiness may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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 right away. Your risk is increased if you use alcohol or other medications that can make you drowsy. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, strange thoughts, thoughts of suicide), decreased sexual desire, missed menstrual periods, nipple discharge, difficulty becoming pregnant. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. 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. 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. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may increase the risk of this drug's side effects and can worsen sleeping problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant (such as unusual sleepiness or difficulty feeding), ask your doctor if you should pump and discard your breast milk during treatment and for 25 hours after a dose of this medication to lessen the risk of these effects in your baby. Get medical help right away if you notice any unusual symptoms in your baby. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of ramelteon from your body, which may affect how ramelteon works. Examples include azole antifungals (such as fluconazole, ketoconazole), fluvoxamine, rifamycins (such as rifampin), viloxazine, among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Prescribing Information

This product information is intended for United States residents only. Before prescribing, please refer to the patient information. You can view the document and also download it on your computer. You may also consider printing out a copy for yourself.

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