ramelteon
Ramelteon (Rozerem) is a sleeping pill used to treat insomnia in adults. It belongs to the drug class known as melatonin receptor agonists and works like melatonin. Ramelteon (Rozerem) is taken by mouth, typically about 30 minutes before bedtime. Unlike some other prescription sleep medications, ramelteon (Rozerem) isn't a controlled substance nor known to be habit-forming. Side effects of ramelteon (Rozerem) aren't common, but can include drowsiness and dizziness.
What is Ramelteon (Rozerem)?
What is Ramelteon (Rozerem) used for?
- Insomnia (difficulty falling asleep)
How Ramelteon (Rozerem) works
Ramelteon (Rozerem) is a melatonin receptor agonists. It acts like melatonin, a natural hormone that your body makes when it's dark. This hormone tells your body to go to sleep in order to maintain a regular sleeping cycle.
Drug facts
Side effects of Ramelteon (Rozerem)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Dizziness (4%)
- Sleepiness (3%)
- Fatigue (3%)
- Nausea (3%)
- Worsening insomnia (3%)
Less Common Side Effects
- Headache
Ramelteon (Rozerem) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: swelling of your face, lips, tongue, or throat; trouble breathing
- Suicidal thoughts or behaviors
More on Ramelteon (Rozerem) side effects
The following Ramelteon (Rozerem) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Dizziness
sleepiness or unusual drowsiness
Less common
Body aches or pain
change in taste
chills
difficulty in breathing
difficulty in moving
discouragement
ear congestion
feeling sad or empty
general feeling of discomfort or illness
irritability
joint pain
loss of appetite
loss of interest or pleasure
loss of taste
loss of voice
muscle aching or cramping
muscle pain or stiffness
pain in joints
shivering
sweating
swollen joints
trouble concentrating
trouble sleeping
unable to sleep
unusual tiredness or weakness
vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Ramelteon (Rozerem)
Pros
- Taken by mouth
- Not a controlled substance and isn't known to be habit-forming
- Fewer side effects than some other sleep medications
- Available as a generic medication
Cons
- Shouldn't take with or right after a high-fat meal
- Can interact with many medications, including fluconazole, rifampin, and fluvoxamine
- Not recommended for people with sleep apnea or severe liver problems
Pharmacist tips for Ramelteon (Rozerem)
- Take ramelteon (Rozerem) on an empty stomach 30 minutes before you sleep. This helps your body absorb the medication faster so that you can fall asleep sooner.
- Swallow the ramelteon (Rozerem) tablet whole. Don't break, crush, or chew the tablets.
- After taking ramelteon (Rozerem), make sure you are fully prepared for bed. Create a relaxing environment by turning down the lights and turning off your phone.
- Take ramelteon (Rozerem) only if you have time to get a full night's sleep. If you don't get enough sleep, you may be less alert the next day.
- Talk to your prescriber if you continue to have insomnia after 7 to 10 days of taking ramelteon (Rozerem) daily. There might be another condition causing your insomnia and it’s important that you get re-examined.
- Don't drink alcohol with ramelteon (Rozerem) as it can raise your risk of experiencing side effects such as unusual behaviors or worsening depression. If you experience these side effects after taking ramelteon (Rozerem), talk to your healthcare professional (HCP) as you might need to stop taking the medication.
- Don't drive after taking ramelteon (Rozerem) until you are fully alert. You might feel drowsy the next day after taking this medication.
Common questions about Ramelteon (Rozerem)
No, the maximum recommended dose of ramelteon (Rozerem) is 8 mg by mouth once a day. Researchers compared the effects of ramelteon (Rozerem) 8 mg with that of ramelteon (Rozerem) 16 mg. Results showed that ramelteon (Rozerem) 16 mg didn't help people sleep any better, but did lead to more side effects like fatigue, headache, and tiredness the next day.
No, ramelteon (Rozerem) isn't a controlled substance. It's not known to carry a risk of addiction or dependence.
Studies show that ramelteon (Rozerem) is not habit-forming and doesn't cause withdrawal symptoms once you stop taking it.
Ramelteon (Rozerem) starts to work within 30 minutes, as long as you take it on an empty stomach. Food, especially those high in fat content) can slow down the time it takes the body to absorb the medication fully, which means it’ll take longer for ramelteon (Rozerem) to work.
Ramelteon (Rozerem) isn't known to cause weight gain as a side effect. But like other sleeping medications, it can cause some people to perform activities while sleeping, including preparing and eating food. And if so, the extra eating might lead to weight gain. It's important to be mindful of this rare side effect and alert loved ones of this potential behavior as you're taking this medication.
Hair loss isn't a commonly reported side effect of ramelteon (Rozerem). If you're experiencing hair loss, tell your prescriber about all the medications you're taking so they can help determine the cause.
No, ramelteon (Rozerem) is only available with a prescription from a healthcare professional (HCP). If you're looking for an over-the-counter option to help you sleep, ask your HCP about melatonin. Ramelteon (Rozerem) works like melatonin, so this might be an alternative for you.
No, don't take ramelteon (Rozerem) and melatonin together, especially without first checking in with your sleep specialist. These medications work similarly in the same areas of the brain to help you maintain a regular sleep cycle. Taking them together can cause you to have too much melatonin in your system and thus have more side effects like fatigue, headache, and sleepiness the next day.
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Risks and warnings for Ramelteon (Rozerem)
Ramelteon (Rozerem) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe allergic reaction
In rare cases, ramelteon (Rozerem) can cause swelling of the face, lips, tongue, or throat due to an allergic reaction. Some people also have nausea and vomiting. This can happen either after your first dose or after taking multiple doses. If you have any of these symptoms, stop taking the medication and get emergency medical help right away.
Changes in behavior and unusual thoughts
- Risk factors: Taking ramelteon (Rozerem) with alcohol | Taking ramelteon (Rozerem) with other medications that slow brain activity (CNS depressants) | History of depression
People taking ramelteon (Rozerem) have experienced changes in their behavior or have had unusual thoughts. This includes hallucinations, worsening depression, and suicidal thoughts. People have also done activities in their sleep while taking ramelteon (Rozerem) that they're unaware of or don’t remember, such as driving, cooking, eating, and making phone calls. If this happens, talk to your healthcare professional (HCP) right away, as you'll likely need to stop taking the medication.
Other causes of insomnia
If your insomnia worsens or isn’t getting better after 7 to 10 days of taking ramelteon (Rozerem), it might be caused by another condition. It’s important to talk to your HCP to re-examine the cause of your insomnia so that they can help find the best treatment for you.
Caution while driving
Ramelteon (Rozerem) is taken to help you sleep. Don’t drive or do anything that requires concentration after taking ramelteon (Rozerem). Also, don't take ramelteon (Rozerem) any sooner than 30 minutes before you're about to go to bed. Wait until you're ready to go to sleep before you take your dose. Then, you should still avoid driving or doing other dangerous activities until you feel fully awake.
Hormonal changes
Ramelteon (Rozerem) can cause changes in your hormones, including lowering your testosterone level and raising your prolactin level. It's unclear whether these changes will lead to any physical side effects. Talk to your prescriber if this is a concern for you.
Ramelteon (Rozerem) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 8mg | 30 tablets | $32.09 | $1.07 |
Typical dosage for Ramelteon (Rozerem)
- Adults: The typical dose is 8 mg by mouth within 30 minutes of bedtime. Don't take ramelteon (Rozerem) with or right after a high-fat meal.
Interactions between Ramelteon (Rozerem) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Calcium Oxybate
- Fluvoxamine
- Magnesium Oxybate
- Potassium Oxybate
- Sodium Oxybate
- Viloxazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Alprazolam
- Benzhydrocodone
- Bromazepam
- Bromopride
- Buprenorphine
- Butorphanol
- Cannabidiol
- Capmatinib
- Carbinoxamine
- Cetirizine
- Clobazam
- Codeine
- Dihydrocodeine
- Doxylamine
- Esketamine
- Fentanyl
- Flibanserin
- Fospropofol
- Gabapentin
- Gabapentin Enacarbil
- Givosiran
- Hydrocodone
- Hydromorphone
- Ketamine
- Lemborexant
- Levocetirizine
- Levorphanol
- Lofexidine
- Loxapine
- Meclizine
- Meperidine
- Methadone
- Metoclopramide
- Midazolam
- Morphine
- Morphine Sulfate Liposome
- Nalbuphine
- Oxycodone
- Oxymorphone
- Pentazocine
- Periciazine
- Pregabalin
- Propofol
- Remifentanil
- Remimazolam
- Scopolamine
- Sufentanil
- Tapentadol
- Tramadol
- Trazodone
- Zolpidem
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
How much does Ramelteon (Rozerem) cost?
Ramelteon (Rozerem) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Ramelteon (Rozerem) will not be safe for you to take.
- Taking fluvoxamine at the same time as ramelteon (Rozerem)
What are alternatives to Ramelteon (Rozerem)?
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