Rozerem - The new sleeping pill

Rozerem (Ramelteon), the first of a new kind of sleeping pill, today gained FDA approval.

Before today, many sleeping pills had potential narcotic-like effects. True, new nonbenzodiazepine sleeping pills — such as Ambien (Zolpidem), Lunesta (Eszopiclone), and Sonata (Zaleplon) — have greatly reduced abuse potential. But they still have a sedating effect throughout the brain. And like earlier sleep drugs, they are controlled substances under federal law.

Rozerem (8-milligram tablets) is the first and only noncontrolled prescription medication for use of insomnia in adults. It is prescribed for insomnia characterized by difficulty with sleep onset.

Rozerem can be prescribed for long-term use. The medication has shown no evidence of abuse and dependence, according to a news release by Takeda Pharmaceuticals North America, the drug’s maker.

Here’s how it’s thought to work. The body has a sleep drive as well as a waking drive. As the day wears on, the sleep drive builds up. But it doesn’t make you fall asleep in the daytime, because that’s when the waking drive is stronger. Later in the evening, the waking drive winds down while the sleep drive continues to build up. By bedtime, the sleep drive is stronger — and you’re ready for normal sleep.

If you’ve got insomnia, the sleep and waking drives get out of balance. Most sleeping pills work by enhancing the sleep drive. Rozerem seems to work by relaxing the waking drive, says psychiatrist Louis J. Mini, MD, Takeda North America’s medical director for neuroscience.

Rozerem should be taken within 30 minutes before going to bed. It should not be taken with or immediately after a high-fat meal. Engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem should be avoided.

The most common side effects seen with Rozerem were somnolence, dizziness, and fatigue. Rozerem should not be used in people with severe liver abnormalities.

Reference - WebMD, Takeda Pharmaceuticals, Rozarem

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3 Responses to “Rozerem - The new sleeping pill”

  1. Ann Says:

    What, exactly, is meant by “long-term use”? Weeks, months, years?

    Do you have any thoughts on ADD and insomnia? It seems my mind races at night and sometimes makes it nearly impossible to fall asleep.

    I would much appreciate your input!

  2. Dr. Sudeep Bansal Says:

    Dear Ann

    As with any other medication (eg. blood pressure pills) these pills can be given for years as long as contra-indications do not exist in the patient such as liver problems.

    However, similiar to antihypertensives adverse effects may develop due to long term usage for which the pill either may have to be substituted or stopped.

    A word of caution - new drugs are not tested for a very long time on humans-so current presciption information may change at a later date ( as what happened for some recent painkillers)

    If you have trouble sleeping you can try these tips for a good night sleep. If this does not work its better to consult your doctor

  3. Anonymous Says:

    This medicine does absolutely nothing for me. I think its a waste of money.

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