Rozerem for sleep onset problems anyone?? | ADHD Information

It seems odd that a rapid heatrbeat was caused by the drug/melatonin precurssor--but I suppose we're all different!

I get a daily email with medical news summaries and recently saw the following article (at http://www.medpagetoday.com/PrimaryCare).

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.
sakura38896.8320138889I tried Rozerem for a week. No help at all. I know that everyone is different but it made me feel like my heart was going to pound out of my chest. Don't know how else to describe it. Needless to say, that didn't help sleep....Has anyone tried this?  I know it’s not an ADHD med, but I suspect many ADHd’ers (on stimulant meds or not) have sleep onset disorder. 
it's recently FDA approved in the US and works on melatonin receptors--not a sedative or hypmotic or narcotic.

Any feedback would be obliged!

Sakura,
   How did you hear about this and what do you know? My seventeen year old son has ADD and has always had trouble falling asleep? Is it Rx? Thankyou!