Ramelteon Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Ramelteon Tablet (ramelteon) is a prescription sleep medicine used to treat insomnia in adults, particularly difficulty falling asleep. It works like melatonin by attaching to melatonin receptors in the brain to help regulate the sleep-wake cycle. Unlike many sleep medicines, it is not a controlled substance and is not habit-forming. It is taken by mouth about 30 minutes before bedtime, only when a full night's sleep is possible.

What is Ramelteon Tablet

Ramelteon is a prescription sleep medicine, also called a sedative or hypnotic, used to treat insomnia in adults. It belongs to a group of medicines that affect the central nervous system and help you fall asleep faster. Its generic name is ramelteon, and it belongs to the drug class of miscellaneous anxiolytics, sedatives, and hypnotics.

Ramelteon Tablet uses

• Treats insomnia (trouble falling asleep)
• Helps you fall asleep faster and may help you sleep through the night
• Treats sleep-onset insomnia
• Helps reduce difficulty falling asleep
• Helps regulate the sleep-wake cycle

Benefits of Ramelteon Tablet

• Shortens the time it takes to fall asleep
• Not a controlled substance and is not habit-forming, unlike many other sleep medicines
• Not a benzodiazepine
• Not classified as a controlled substance in the U.S.
• Low potential for physical dependence
• Usually causes less dependence risk than many sedative-hypnotics

How Ramelteon Tablet works

Ramelteon works like melatonin, a natural substance your body makes. It attaches to melatonin receptors in the brain to help regulate your sleep-wake cycle (circadian rhythm).

Ramelteon Tablet dosage

Take this medicine by mouth, about 30 minutes before you go to bed, and only when you are ready to go to sleep for a full night. Swallow the tablet whole; do not cut, break, crush, or chew it. Do not take it with or right after a meal, especially a high-fat meal, since this can slow down how well the medicine works. After taking it, do not do anything except get ready for bed. Only take a dose if you have a full 7 to 8 hours available for sleep before you need to be active again.

If you miss a dose, skip it and go back to your normal schedule; do not take double doses. Use in children and teens under 18 has not been approved; your doctor must decide on use and dosing in children. No special dosing differences have been shown to be needed for elderly patients, but caution and monitoring for sleep-related behaviors and thinking problems is advised.

Available forms and strengths

Ramelteon is available as a tablet.

Side effects of Ramelteon Tablet

Common

• Dizziness
• Drowsiness or sleepiness, including the next day
• Fatigue
• Nausea
• Headache
• Worsened insomnia or strange dreams

Serious

• Severe allergic reaction (anaphylaxis or angioedema) with swelling of the face, lips, tongue, or throat, hives, itching, or trouble breathing
• Doing activities while not fully awake and not remembering them later, such as sleep-driving, sleep-walking, making phone calls, having sex, or preparing and eating food
• Mood or behavior changes such as new or worsening depression, anxiety, confusion, hallucinations, irritability, hostility, or thoughts of suicide or self-harm
• Hormone changes such as high prolactin levels, causing unexpected breast tissue growth, nipple discharge, changes in sex drive, or irregular menstrual periods

Warnings and precautions

• This medicine can cause a severe, life-threatening allergic reaction with swelling of the face, lips, tongue, or throat and trouble breathing. Get emergency help right away if this happens.
• Some people have done activities like driving, cooking, or making phone calls while not fully awake and had no memory of it afterward. Tell your doctor right away if this happens to you.
• This medicine should not be used together with the medicine fluvoxamine (Luvox).
• Insomnia that continues after 7 to 10 days of treatment could be a sign of another health problem and should be checked by your doctor.
• After stopping this medicine, you might have trouble falling asleep for a night or two. This usually goes away on its own.
• Tell your doctor if you are pregnant or trying to become pregnant. Human data available so far have not shown an increased risk of major birth defects, but your doctor should weigh the benefits and risks for you.
• There isn't enough research to know the risk to a nursing infant. Talk with your doctor about the benefits and risks before using this medicine while breastfeeding. You should not breastfeed for 25 hours after taking a dose, and should throw out any milk pumped during that time.
• No routine renal dose adjustment is generally required.
• People with moderate liver disease may have higher levels of the medicine in their blood, raising the risk of side effects. People with severe liver disease should not take this medicine.
• Do not drink alcohol while taking this medicine, since alcohol can add to its sedating effects and increase the risk of dangerous side effects.
• This medicine can make you drowsy, dizzy, or less alert, which can affect your coordination, reaction time, and judgment. Do not drive or use machinery until you know how it affects you.

Storage

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light
• Keep from freezing
• Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F)
• Protect from light and moisture; keep the container tightly closed
• Keep out of the reach of children and pets
• Do not keep outdated medicine or medicine no longer needed
• Ask your healthcare professional or pharmacist how to properly dispose of unused medicine; some medicines can be taken to a medication take-back program

When to see a doctor

• Get emergency help right away if you have signs of a severe allergic reaction, such as hives, itching, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
• Call your doctor right away if you find out you have done unusual activities you don't remember, such as driving, eating, or sleepwalking, while not fully awake.
• Call your doctor right away if you or your family notice new or worsening depression, thoughts of harming yourself, anxiety, confusion, hallucinations, or memory problems.
• Tell your doctor if you notice breast tissue growth, nipple discharge, changes in sex drive or performance, or irregular periods.
• If you think you've taken too much of this medicine, contact a poison control center or go to an emergency room right away.

Alternatives

• Suvorexant
• Low-dose doxepin
• Melatonin
• Rozerem