Ramelteon is the generic version of and active ingredient in brand name Rozerem. Providers prescribe ramelteon as a sedative/hypnotic medication to treat insomnia, particularly for people who struggle to fall asleep.
Do you need ramelteon for your sleep issues? Find out by finding an insomnia specialist on Klarity Health. A healthcare provider will determine the right insomnia treatment plan for you, and if it includes ramelteon.
Providers on Klarity Health are independent practitioners with clinical autonomy; a diagnosis, treatment, or prescription is not guaranteed.
Providers on Klarity Health are independent practitioners with clinical autonomy; a diagnosis, treatment, or prescription is not guaranteed.
Ramelteon is a sedative/hypnotic drug used to treat insomnia. The U.S. Food and Drug Administration (FDA) approved Rozerem, the brand name version of ramelteon, for insomnia with trouble falling asleep in 2005. The FDA approved generic ramelteon tablets for the same use in 2019.
In 1 study, ramelteon significantly reduced the amount of time it took patients to fall asleep when compared to the placebo. Study participants didn’t have withdrawal symptoms or rebound insomnia when discontinuing ramelteon.
Ramelteon can also be used off-label to treat short-term circadian rhythm sleep disorders, like jet lag and shift work.
Ramelteon is a sedative-hypnotic drug in a medication class known as melatonin receptor agonists. This class of medications works in a similar way to melatonin, which is a natural hormone found in the brain that helps with your body’s internal clock, circadian rhythms, and sleep.
Ramelteon acts on melatonin receptors, which help regulate the sleep cycle. Most melatonin receptors are in the suprachiasmatic nucleus (SCN), which is a bilateral structure found in the brain’s hypothalamus that manages the circadian rhythms of wakefulness and sleep. Ramelteon binds to specific melatonin receptors in the SCN, which helps promote sleep. Its effect on melatonin receptors is 3 to 16 times higher than the body’s natural melatonin.
Ramelteon is FDA-approved to treat adults with insomnia, specifically trouble falling asleep.
There are certain groups of people who shouldn’t take ramelteon, including those who:
• Are allergic to ramelteon
• Have severe liver disease
• Are also taking fluvoxamine
You should also let your provider know if you’ve ever had sleep apnea, breathing issues, liver disease of any kind, mental illness, depression, or suicidal thoughts or if you’re currently pregnant or breastfeeding.
Ramelteon isn’t FDA-approved for use in children.
You can get a ramelteon prescription online during a telehealth visit with a licensed, trained healthcare provider. If the provider you see determines that ramelteon is the right treatment for your insomnia symptoms, they can give you a ramelteon prescription online or send it to your chosen pharmacy.
Healthcare providers licensed to prescribe medications include nurse practitioners (NPs), physician assistants/associates (PAs), and medical doctors (MDs).
When your provider submits your ramelteon prescription to an online or local pharmacy, you can either pick the prescription up or have ramelteon delivered to your home.
Find a licensed and board-certified provider on Klarity Health for an insomnia treatment plan that may or may not include ramelteon or another medication.
Some states require at least one in-person visit with a provider before they can prescribe medication. See the Center for Connected Health Policy site for details on your state’s requirements.
Ramelteon comes in 1 strength, 8 milligrams. Providers typically prescribe that 1 8-milligram oral ramelteon tablet be taken within half an hour of going to bed. You don’t want to take it with or right after eating a high-fat meal. Swallow your tablet whole rather than crushing, chewing, or splitting it.
The maximum dose for ramelteon is 8 milligrams a day.
Ramelteon isn’t recommended if you have severe hepatic (liver) impairment and should be used cautiously if you have moderate hepatic impairment.
If you take ramelteon, follow the instructions on the prescription label. And ask your provider or pharmacist if there’s anything you don’t understand on the label.
The most common side effects of ramelteon are drowsiness, fatigue, dizziness, nausea, and worsening insomnia. There are also more serious side effects of ramelteon, including severe allergic reactions; abnormal behavior changes, thinking, and complex behaviors like sleep-driving; and effects on the central nervous system (CNS). Ramelteon can also have an impact on reproductive hormones in adults, including increased prolactin levels and reduced testosterone levels.
Some medications can have drug interactions with ramelteon, including fluvoxamine (Luvox), carbamazepine (Tegretol, Carbatrol, and Equestro), rifampin (Rifadin and Rimactane), ketoconazole (Daktarin, Dandrazol, and Nizoral), fluconazole (Azocan, Diflucan, and Canesten), donepezil (Aricept), doxepin (Silenor), and alcohol.
People who shouldn’t take ramelteon, include those who are allergic to ramelteon, people with severe liver disease or hepatic impairment, people taking fluvoxamine (Luvox), and people with severe sleep apnea. Let your provider know if any of these medical conditions apply to you, so they can find another insomnia treatment for you.
If you take ramelteon and have any side effects, work with your provider and consider reporting negative side effects to the FDA by visiting MedWatch or calling 1-800-FDA-1088.
Ramelteon costs about $87 for a 1-month supply of 30 8-milligram tablets if you use the drugs.com discount card, which is accepted at many U.S. pharmacies. The price for 30 ramelteon tablets can be higher or lower based on which pharmacy you visit.
Brand name Rozerem costs more, at about $419 for a 1-month supply of 30 8-milligram tablets.
If you have insurance that covers Rozerem or ramelteon, you may pay less. And with or without insurance, prescription discount sites, like SingleCare Rx, Optum Perks, GoodRx, drugs.com, and NeedyMeds, can help you save up to 80% on the cost of ramelteon or Rozerem.
Ambien (zolpidem) is one of the most popular insomnia medications in the U.S. Like ramelteon, it’s a non-benzodiazepine sedative-hypnotic medication and was approved by the FDA for short-term treatment of insomnia because of difficulty falling asleep in 1992. Unlike ramelteon, Ambien is a controlled substance and has a high risk for dependence, abuse, and addiction. Side effects include headache, dizziness, diarrhea, allergic reactions, trouble breathing, withdrawal symptoms, odd behaviors or thoughts, suicidal thoughts, and increased depression.
While ramelteon is a sedative-hypnotic, Quiviq (daridorexant) is a brand name orexin receptor antagonist (ORA) medication approved by the FDA for the treatment of insomnia due to difficulty of sleep onset or sleep maintenance in 2022. Side effects include headache, fatigue, CNS effects, worsening of suicidal ideation or depression, sleep paralysis, sleep hallucinations, complex sleep behaviors like sleepwalking or sleep driving, and breathing issues.
Doxepin was originally approved by the FDA in 1969 as a tricyclic antidepressant. It was later approved to as brand-name Silenor to treat chronic insomnia, specifically trouble staying asleep, in 2010. While ramelteon is approved to treat difficulty falling asleep, doxepin is approved to treat trouble staying asleep. Adverse events of doxepin include sedation, upper respiratory tract infection, gastroenteritis, nausea, hypertension or high blood pressure, abnormal behavioral changes or thinking, worsening of depression, suicide risk, and CNS effects.
Belsomra (suvorexant) is a brand-name ORA medication approved by the FDA in 2014 to treat chronic insomnia associated with trouble falling or staying asleep. Side effects of Belsomra include diarrhea, dry mouth, upper respiratory tract infection, headache, dizziness, abnormal dreams, cough, CNS effects, daytime impairment, worsening depression or suicidal ideation, complex sleep behaviors, sleep paralysis, sleep hallucinations, and breathing issues.
The best way to find out which insomnia medication is best for you, if any, is to talk to an insomnia specialist.
Reviews from real patients who received treatment from healthcare providers on Klarity Health.
Providers on Klarity Health are licensed and board-certified. They offer a personalized approach to your unique medical needs. See a detailed profile and services for each provider and find the one best suited for your needs. Providers run their own private practice, and their service options can vary and tailor to your unique needs.
Your journey to better sleep starts with an initial appointment. Your provider will go over your goals and medical history to recommend a treatment plan that’s right for you. Your plan may or may not include prescription medication.
After your initial appointment, you and your provider stay connected to make sure you’re doing okay and reaching your goals. You stay on track with follow-up appointments, medication refills, and ongoing support from your provider. You’re encouraged to regularly check in with your providers.
If you have questions or need assistance, the Klarity Health Patient Support team is here to help. Along with your provider, they’re committed to making sure you have the best care and support possible.
*Appointments are generally available within 24 hours. Free initial consultations are available only with select providers. Prescriptions, particularly for controlled substances, may require an in-person evaluation depending on the state of residence and current federal regulations.
The information provided in this article is for educational purposes only and should not be construed as medical advice. Controlled substances may not be appropriate for all patients and any mention of these medications is for educational purposes only, not for marketing or encouraging self-diagnosis. Always seek the guidance of a qualified healthcare professional with any questions or concerns you have regarding your health. Providers on Klarity Health are independent practitioners with clinical autonomy. Nothing in this article is intended to diagnose or treat any condition, including guaranteeing prescription medication of any kind or dosage. Not all providers on Klarity Health prescribe all medications, particularly medications that are controlled substances.
If you’re having a mental health crisis or experiencing a psychiatric emergency, it’s crucial to seek immediate help from a mental healthcare professional, such as a psychiatrist, psychologist, or therapist. You can also call your local emergency services, visit your nearest emergency room, or contact a crisis hotline, such as the National Suicide Prevention Lifeline, by calling or teTrazodoneting 988 or dialing the Lifeline’s previous phone number, 1-800-273-TALK (1-800-273-8255) in the U.S.