Ramelteon (Roserem) 8 mg, 100 tablets: profile, composition and research
Reference page for Ramelteon (Roserem) 8 mg, 100 tablets. Active substance: Рамелтеон / Ramelteon.
- What it is: ramelteon, a synthetic agonist of the MT1 and MT2 melatonin receptors.
- Presentation: 8 mg tablets, 100 tablets per pack.
- Status: prescription-only medicine.
- Research: studies in chronic insomnia, links below.
- Where to buy: APV Pharmacy (price and availability there).
Key facts
| Active substance | Ramelteon |
|---|---|
| Form | Tablets |
| Strength | 8 mg per tablet |
| Pack size | 100 tablets |
| Category | Prescription medicine |
| Article (SKU) |
What ramelteon is
Ramelteon is a synthetic substance that acts on the same receptors as melatonin, a hormone the body produces itself. It belongs to the class of melatonin receptor agonists: the molecule binds the MT1 and MT2 receptors and switches them on much as melatonin does.
The medicine is supplied as 8 mg tablets, 100 tablets to a pack. It is a prescription-only product, and it is a physician who decides on its use rather than the patient alone.
Melatonin helps to maintain the circadian rhythm, the internal clock that governs the alternation of sleep and wakefulness. Ramelteon reproduces part of that signal, which is why it has been studied mainly in insomnia marked by difficulty falling asleep.
How ramelteon works
A target in the brain
The MT1 and MT2 receptors sit in the suprachiasmatic nucleus of the hypothalamus, the region that sets the daily rhythm. Ramelteon binds them as a full agonist and sharpens the sensitivity of this system to the signal that night has begun.
A difference from sleeping pills
Unlike medicines that act through GABA receptors, ramelteon does not touch that complex and shows no meaningful binding to receptors for serotonin, dopamine, noradrenaline, acetylcholine or opiates. The intention is a lighter influence on sleep depth.
The active metabolite M-II
The main metabolite, M-II, remains active: its affinity for the MT1 and MT2 receptors is roughly ten and five times weaker, while its concentration in the blood is higher than that of the parent substance. It binds weakly to serotonin 5-HT2B receptors; the remaining metabolites are inactive.
Approved uses
The manufacturer's information names insomnia characterised by difficulty falling asleep and by a shortened duration of sleep. It concerns adult patients, and the decision to use the medicine rests with a physician who has assessed the causes of the sleep problem.
Insomnia is often the consequence of other conditions - anxiety, depression, sleep apnoea, or the use of other medicines. Before prescribing, a physician therefore looks for the cause and only then considers pharmacological support.
This is a prescription medicine. The length of treatment and the need for further courses are decided by a specialist, while a reference page neither replaces a consultation nor offers personal advice.
What the research shows
In a double-blind multicentre trial in patients with chronic insomnia, ramelteon at 8 and 16 mg shortened the time to fall asleep by roughly 15-20 minutes against placebo: about 29-32 minutes instead of 48 minutes. Total sleep time did not differ from placebo.
A faster effect was noted in the first one or two weeks of use, but by the fourth week the difference from placebo had become close to zero. Patients nevertheless rated their sleep as longer than the objective recordings showed it to be.
No published study directly compares ramelteon with melatonin, although both act on the same receptors. There is not yet enough evidence to claim an advantage for one over the other.
Published research
Primary sources, verified against PubMed:
- Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia., PubMed 17803013 (Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2007).
- Long-term safety and efficacy of ramelteon in Japanese patients with chronic insomnia., PubMed 21277255 (Sleep medicine, 2011).
- Evaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia., PubMed 21256803 (Sleep medicine, 2011).
- A double-blind, randomized, placebo-controlled trial of adjunctive ramelteon for the treatment of insomnia and mood stability in patients with euthymic bipolar disorder., PubMed 22963894 (Journal of affective disorders, 2013).
Listed for reference. Publication of a study is not a claim about this particular product.
Precautions
- This is a prescription medicine. Prescribing, dosing and monitoring belong to a physician.
- Ramelteon can slow reactions. Driving and operating machinery call for care at the start of treatment.
- Alcohol and other substances that act on the central nervous system may deepen drowsiness.
- The medicine is not used in severe liver impairment; in moderate impairment the decision rests with a physician.
- Use during pregnancy or breastfeeding is discussed with a doctor individually.
- Tell your doctor about every medicine you take: some, such as fluvoxamine, alter the handling of ramelteon.
Frequently asked
Is ramelteon a prescription medicine?
Yes. It is a prescription medicine and is not intended for self-medication.
Why does this page not give a dosing schedule?
The dose and the length of the course are set by a physician, taking the causes of the insomnia and the patient's condition into account. A reference page does not prescribe treatment.
How does ramelteon differ from melatonin?
Both act on the MT1 and MT2 receptors, but they are different molecules handled differently by the body. Published studies do not compare the two directly.
Where does the order ship from?
Shipping and customs handling are described on the APV Pharmacy delivery page.