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Ramelteon FDA Approved Insomnia Treatment

Ramelteon is prescribed to people who have trouble falling asleep due to sleep-onset insomnia. Ramelteon is a pharmacological compound classified as a selective agonist of the melatonin receptors MT1 and MT2.

Ramelteon, commercially known as Rozerem, is a pharmaceutical compound classified as a melatonin receptor agonist, which replicates endogenous melatonins physiological effects.

The human body secretes melatonin during periods of darkness to maintain a consistent sleep-wake cycle. The pharmacological agent known as Ramelteon, which has melatonin-like properties, expedites the initiation of somnolence.

Why is Ramelteon recommended for Insomnia by Doctors?

Ramelteon is commonly used for individuals experiencing difficulty initiating sleep due to sleep-onset insomnia. Ramelteon is classified as a member of the melatonin receptor agonists pharmacological class. It operates in a manner comparable to the endogenous melatonin produced by the brain, which plays a crucial role in facilitating sleep.

The following is an elaborate exposition of the products characteristics and features.

What is the recommended Ramelteon Treatment for Insomnia?

The oral formulation of Ramelteon is commercially accessible in tablet form. It is advised to administer a single dose daily, with a minimum interval of 30 minutes before the desired bedtime. It is advisable to refrain from consuming Ramelteon immediately before or after a meal.

It is advisable to consult with your healthcare professional or pharmacist for clarification on any instructions provided on your prescription label that you may find unclear or uncertain about adhering to.

It is imperative to adhere to the suggested dosage regimen when consuming Ramelteon. It is essential to adhere strictly to the prescribed dosage and frequency of administration as instructed by your physician.

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

Ramelteon Daily Insomnia Doses

Following the administration of Ramelteon, individuals may experience a state of fatigue within a relatively short duration. It is advisable to undertake all necessary nighttime preparations before consuming Ramelteon and retiring to bed. Please refrain from scheduling any additional activities during this period.

It is advised to refrain from using Ramelteon if one cannot allocate a sufficient duration of seven to eight hours for sleep.

Ramelteon Safety

The topic of safety is of paramount importance in various domains and contexts. It encompasses the measures.

There is no evidence to suggest that Ramelteon poses any substantial safety concerns. Following a year-long engagement in the trial, it was seen that a total of 3.1% of the patients encountered one or more noteworthy adverse events. However, it is worth noting that less than 10% of these incidents were directly associated with the administration of the drug ramelteon.

Patients who have concurrently prescribed fluvoxamine (Luvox), a medication known to inhibit the metabolism of Ramelteon, or those with significant hepatic impairment are advised against using Ramelteon.

The administration of Ramelteon has been found to elevate the blood concentrations of fluconazole (Diflucan) or ketoconazole (Nizoral), perhaps leading to an increased likelihood of experiencing adverse effects or therapeutic outcomes.

The concurrent administration of Ramelteon and alcohol does not yield a substantial enhancement in the pharmacological effects of the former.

Children and adolescents should refrain from using it due to the lack of testing conducted explicitly on this demographic. It is not recommended for lactating mothers to use Ramelteon.

Ramelteon Tolerability

The concept of tolerability refers to the ability of an individual or a group to endure or overall, Ramelteon is generally well tolerated. During the clinical trials, the dropout rate for participants administered Ramelteon was 5%, whereas the placebo group exhibited a dropout rate of 2%.

Ramelteon does not indicate any residual effects commonly associated with post-administration symptoms.

In clinical trials lasting 35 days, the administration of Ramelteon did not reveal any evidence of rebound insomnia. Furthermore, upon discontinuation of the drug, no withdrawal symptoms were observed.


What is Ramelteon? Ramelteon (Rozerem), a melatonin receptor agonist, imitates the effects of melatonin. When it becomes dark, your body produces melatonin to aid in a regular sleep cycle. The melatonin-like drug ramelteon (Rozerem) accelerates the onset of sleepiness.

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).

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.

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.

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 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.

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.

Not applicable.

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.

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