Rozerem is a prescription medication and the trademark under which Ramelteon is marketed by Takeda Pharmaceutical. The product is FDA approved and is advertised as an insomnia treatment for adults. The manufacturer claims the product is non-habit forming and will not induce discomfort (“hung-over” feeling) the day next to its use.
The drug is classified as a melatonin receptor agonist with both high affinity for melatonin MT1 and for MT2 receptors. These are believed to assist in maintaining the circadian rhythm underlying the normal sleep-wake cycle.
The product is supposed to help adults who experience mild to severe insomnia symptoms. Ramelteon’s effectiveness has been clinically proved in a double-blind multi-center trial (it reduced time to fall asleep by approximately 15 to 20 minutes).
Rozerem includes the following ingredients: Lactose Monohydrate, Hydroxypropyl Cellulose, Starch, Magnesium, Titanium Dioxide, Synthetic Iron Oxide (black), and Ferric Oxide Rozerem (yellow).
Rozerem is part of a relatively new class of sleep agents that selectively binds to the MT1 and MT2 receptors, instead of binding to GABA receptors, a mechanism of action on which all other sleep treatments work. In 2005, the drug was approved by the U.S. FDA for long-term use.
The manufacturer mentions a list of potential serious side effects, such as: Side effects may include somnolence, fatigue, dizziness, nausea, and exacerbated insomnia. The drug may affect as well testosterone and prolactin hormone levels (changes in period, libido, fertility problems).
Also, there are some precautions associated to the drug, which includes: patients who are under treatment with LUVOX® (fluvoxamine) or have severe liver problems
If mixed with alcohol, the probability for driving, sleepwalking, eating, or other behaviors performed while not fully awake may increase.
Daily dosage depends on several factors and should be established after a full evaluation of a healthcare provider.
- The product is FDA approved
- The drug has been clinically tested and proved effective
- Revolutionary solution against insomnia
- Non-habit forming
- Severe potential side effects
- Long list of precautions and drug interaction
- Rather expensive
Research has shown that Rozerem (Ramelteon) can reduce the time to fall asleep up to 20 minutes. Consumer opinions are both positive and negative. On the negative things list most mentioned are the short-term effectiveness, the unpleasant side effects and price.
Even though its’ mechanism of action is innovative, the product has a long list of associated side effects. A medical recommendation is required before starting treatment in order to establish dosage, which depends on age, weight and general health status. It is advised the product is taken before going to bed, since it may interfere with daily activities, such as driving.
This is a prescription drug and should only be taken on medical recommendation.