A new treatment was recently approved by the FDA for insomnia. Rozerem (Ramelteon) has a different mechanism of action than other sleep medications. It works by stimulating two of the melatonin receptors in the brain. It does not stimulate the melatonin receptor that can constrict arteries and so therefore should not have the potential risks associated with high doses of melatonin.
Since melatonin is a natural hormone that induces sleep, Rozerem should produce normal sleep. It has been shown to induce the normal sleep stages of EEG. Rozerem is not structurally or chemically related to melatonin. Melatonin is a much simpler structure and is derived from serotonin.
Studies have shown Rozerem (on the market as 8mg tablets) to be better than placebo at helping people stay asleep. It has a fairly short duration (1/2 of it is gone within 1-2.5 hours). My guess is that it is especially helpful when the sleep problem is related to the circadian rhythm being off – i.e., the normal melatonin peak being either early or more likely late due to lack of adequate am bright outside light exposure. Shift work and other irregular sleep schedules can also interfere with normal physiology of sleep.
Rozerem may be particularly helpful in adolescents – who don’t usually do well on typical sleep medications. It may also be helpful for insomnia in the elderly who have reduced melatonin (that usually peaks in the late afternoon or evening).
Rozerem probably won’t be helpful for severe insomnia or insomnia associated with anxiety or mood disorders. Development of tolerance hasn’t been seen but we don’t have very long studies. It may be helpful added on to other sleeping pills when they are not fully effective.
One concern is that melatonin can increase prolactin and decrease testosterone/estrogen levels. This effect has been reported in an occasional patient on Rozerem. Complications of this hormone effect could be decrease in libido in the short term but long term cause other physical problems.
