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Medication News & Update

Insomnia

     A new non-narcotic sleep aid has been approved. Ramelteon (Rozerem) is indicated for sleep onset insomnia. It does not help to maintain sleep. It is an effectgive alternative to the narcotic sleep aid Sonata which is also only indicated for sleep onset insomnia. Unlike other prescription sleep medications, ramelteon works by selectively affecting melatonin MT1 and MT2 receptors, which are believed to be involved in the circadian rhythm underlying the normal sleep-wake cycle. Most other sleep aids prescribed work by binding to gamma-aminobutyric acid (GABA) receptors, which reduce central nervous system activity. Because of its mechanism of action Ramelteon has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day hangover effects.

      Ramelteon is hepatically metabolized, primarily by the CYP1A2 isoenzyme. The manufacturer advises that ramelteon not be used in combination with fluvoxamine, a strong CYP1A2 inhibitor. The coadministration of the two agents has been shown to significantly increase ramelteon concentrations. Additionally, ramelteon should be administered with caution in patients taking rifampin, ketoconazole, and fluconazole.

The most common adverse events associated with ramelteon in clinical trials were somnolence, dizziness, nausea, and fatigue. Ramelteon has been associated with decreased testosterone levels and increased prolactin levels. Therefore, the package labeling recommends that for patients presenting with any unexplained symptoms possibly associated with these hormone level changes, assessment of prolactin and testosterone levels should be considered appropriate.   for more information contact us.