rozerem for sleep problems

Discussion in 'Fibromyalgia Main Forum' started by ephemera, Sep 9, 2005.

  1. ephemera

    ephemera New Member

    Got a new sleep prescription today for Rozerem. Previously Ambien & Lunesta did nothing for me & I was awake hours later.

    Sleep doc said I'd be her first patient on Rozerem. Went to 2 pharmacies which didn't have it in stock. Local CVS is ordering it for early next week delivery.

    Anyone else out there getting this new drug? Will post my reactions & results as soon as the pills appear.
  2. ChattyCathy

    ChattyCathy New Member

    I have never heard of it but am happy to learn that there is a new one out. Try doing a search to learn more about it - and please keep us posted as to how it works for you.

    The new one that I recently heard of was: Xyrem...

    Still using Trazadone - works for me
  3. fivesue

    fivesue New Member

    As I'm sitting here at "0 dark thirty" as some say, it is great to know there is a new med for sleep. Please let us know how it works as I have used all the normals, but I just don't sleep. I do hope it works well for you!

    Sweet dreams,
  4. ephemera

    ephemera New Member

    Here's some info from my internet search.

    FDA Approves Rozerem for Insomnia

    By Katrina Woznicki, MedPage Today Staff Writer
    July 25, 2005
    Also covered by: Bloomberg, Chicago Tribune (Registration Req.), LA Times (Registration Req.)

    ROCKVILLE, Md., July 25-The FDA has approved Rozerem (ramelteon), the first melatonin receptor agonist, for the treatment of insomnia. Unlike other modern sleeping pills, Rozerem was not designated as a controlled substance.

    Clinical trials showed no evidence of dependance or abuse of the drug, which was approved at the 8 mg dosage to help patients who suffer from acute or chronic insomnia. Melatonin is believed to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle.

    "It really is the first of prescription (sleep aid) drugs in recent times to not be scheduled," said Robert Meyer, M.D., director of the pertinent office of drug evaluation at the FDA. "I suspect that will be something that will differentiate it from the others."

    Manufactured by Takeda Pharmaceuticals North America, Rozerem works by targeting two receptors, MT1 or MT2, in the suprachiasmatic nucleus, which controls circadian rhythms. The activity of Rozerem at the MT1 and MT2 receptor level is believed to contribute to its sleep-promoting properties, said Takeda.

    "All of its mechanism is not fully known at this point," Dr. Meyer said. "But we know it works. And it does not have a limitation in its labeling for its duration of use." Many over-the-counter sleep aids, he added, are intended for only seven to 10 days because of abuse or dependency potential.

    Takeda said Rozerem should be taken a half hour before bedtime and that once the drug is taken, activities should be limited to those associated with going to bed.

    Clinical trials involving more than 4,200 patients, ages 18 to 93, showed the drug was generally well tolerated. The most common side effects reported were somnolence, fatigue, and dizziness.

    Because Rozerem is metabolized by the liver, the drug company cautioned the drug should not be used by patients with severe hepatic impairment.

    The company also said patients taking Luvox (fluvoxamine) should not take Rozerem. Patients with depression should also be closely monitored if they are prescribed Rozerem because of potential to exacerbate symptoms.

    "We saw in the clinical trials that Rozerem could increase depression in people who are depressed," Dr. Meyer said. "We did not see any clear signals of suicide ideation."

    However, the manufacturer warned suicidal thoughts have been reported with the use of hypnotics.

    Rozerem has not been studied in patients with sleep apnea or those with severe chronic obstructive pulmomary disease. The drug has not been tested in children or adolescents.