A safer and milder sleep aid Rozerem/Ramelteon

You may have heard about the most recent FDA approved prescription sleep aid, Rozerem (Generic Name: Ramelteon), or even seen one of the commercials on the drug, such as the insomniac talking to Abraham Lincoln. Unfortunately, sleep aid commercials do not often provide fair representations of these medications and Rozerem is no exception. Loss of libido and lactating breasts for instance, both potential Rozerem side effects, are not well publicized.
If sleep aid commercials were accurate, the one on Lunesta, for example, would show a drunk-like butterfly bumping into the walls, or one too tired to fly. This would represent how Lunesta affects some people.

While sleep aids are a wonderful invention, and insomnia is a serious problem, sleep aids are not without potential side effects and risks. Yet, Rozerem is clinically shown to be better tolerated than conventional sleep medications and is the first FDA approved medication for insomnia that is not a controlled substance.

Who Can Benefit From Rozerem?
As they say, your doctor will determine if Rozerem is right for you, but the following categories of individuals are noted to possibly benefit from Rozerem:
People diagnosed with insomnia concerned about the usual side effects of sleep aids, such as grogginess, memory loss and poor balance, may find Rozerem useful.
Rozerem is non-narcotic and shows zero incidence of addiction or tolerance, so Rozerem may be recommended for individuals who have these concerns. No rebound insomnia has been shown in clinical studies so Rozerem can be safe for long-term use. With a low incidence of side effects and few drug interactions, Rozerem is a sleep aid reportedly worthy of consideration for the elderly insomnia.

How Does Rozerem Work?
Sleep is regulated by an internal master clock, which under optimal circumstances sends the proper signals to the brain during the sleep/wake cycle, sometimes referred to as the circadian rhythm. This 'clock' involves a small cluster of neurons located in the hypothalamus and is called the suprachiasmatic nucleus (SCN). Rozerem works by affecting only specific melatonin receptors in the SCN. Melatonin is a natural hormone the body produces that is believed to help regulate sleep. It is also a hormone our body tends to produce less of as we age. When individuals experience insomnia their internal clock may be off balance and lacks the right signals for sleeping. Rozerem is thought to work by assisting this balance via melatonin.
Unlike most sleep aids that affect several areas of the brain and/or the central nervous system, Rozerem only targets specific melatonin receptors. This limited action is thought to largely explain why there are relatively few side-effects with Rozerem and why addiction or dependence has not been noted.

Rozerem Drawbacks
The primary drawback of Rozerem, besides side effects, is that it may not work sufficiently. Other causes may be involved in insomnia that Rozerem doesn't address.
Another issue is that clinical trials have not shown Rozerem to be particularly more effective than over-the-counter (OTC) melatonin. However, an individual would likely need a higher than recommended dosage of melatonin to get the same effect as with 8mg. of Rozerem.
Additionally, as Rozerem is a prescription its manufacturing is regulated and theoretically of more stable quality than OTC melatonin and may instead be covered by insurance.

Potential Rozerem Side Effects
Rozerem has comparatively few known side effects but worth noting is that Rozerem has been associated with decreased testosterone levels and increased prolactin levels. Patients taking Rozerem with unexplained amenorrhea (absence of menstrual cycle), galactorrhea (secretion of breast milk), decreased libido, or fertility problems should have these issues investigated. It is recommended that prolactin levels and testosterone levels be tested as appropriate.
Rozerem is not recommended for adolescents as the affect on the reproductive cycle is unknown; the same is true of OTC melatonin.
More common side effects (adverse events) in clinical trials involving 3594 subjects taking Rozerem include, include somnolence (0.8%), dizziness (0.5%), nausea (0.3%), fatigue (0.3%), headache (0.3%), and insomnia (0.3%). About five percent (5%) of the study group discontinued Rozerem treatment for an adverse symptom thought to be attributed to the medication. This is in comparison to two percent (2%) of the 1370 individuals who received a placebo. Other side effects have been mentioned, whether related to Rozerem or not, and any new adverse symptoms should be discussed with a health professional.

Rozerem Warnings and Precautions
Drug Interactions: The following drug combinations are not normally prescribed and may be dangerous, consult your healthcare professional for more information.
Rozerem and Fluvoxamine (Brand Name: Prozac): Severe, life-threatning drug interaction may occur as Fluvoxamine can causes Rozerem to metabolize very slowly in the liver and consequently produce very high levels of Rozerem in the blood.

Rozerem and Rifampin: This combination can speed up how Rozerem is processed through the liver and may cause additional side effects when Rifampin is discontinued.
Rozerem is not recommended for people with severe liver problems or hepatic damage.
Clinical studies in mice showed an increased rate of hepatic tumors when healthy mice received several times the standard Rozerem dose. The association to humans is unknown so the cause may involve other processes. This list of Rozerem warnings is not all inclusive. Ensure your healthcare professional is aware of medications you are taking and any side effects you experience.