Monday, November 5, 2012

FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes

The Food and Drug Administration (FDA) announced the approval of Cymbalta (duloxetine hydrochloride) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Cymbalta received a priority review. "Diabetes affect millions of Americans," said Dr. Lester M. Crawford, Acting FDA Commissioner. "With this new treatment we will hopefully be able to help relieve the pain associated with this terrible disease." Diabetic peripheral neuropathy is a problem associated with long standing diabetes or poor glucose control. Peripheral neuropathy is the most common complication of diabetes mellitus, affecting up to 62% of Americans with diabetes. Diabetic peripheral neuropathy can manifest in a variety of ways but is usually characterized by burning, tingling, and numbing sensations beginning in the feet, and later affecting the legs and/or hands. The safety and effectiveness of Cymbalta were established in two randomized, controlled studies of approximately 1074 patients. Although the mechanism of action is unknown, patients treated with Cymbalta reported a greater decrease in pain compared to placebo. In these trials, 51 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. In comparison, 31 percent of patients treated with placebo reported this magnitude of sustained pain reduction. The most commonly reported side effects were nausea, somnolence, dizziness, decreased appetite, and constipation. In some cases, patients experienced dizziness and hot flashes. Cymbalta is manufactured by Eli Lilly and Company in Indianapolis , Ind.
I have had chronic pain/numbness/tingling sensations in the left side of my face for over 15 years. It was slight when it first started, but turned really bad around 2005. I have been on a Vicodin, Tramadol, Fioricets "cocktail" for 8 years. I tried Neurontin for 5 months but it made me sluggish, lazy, and depressed. Neurontin didn't solve anything. Last week a Neuroligist strongly suggested I try Cymbalta, and ease off all other presciption/non prescription pain killers. Within 24 hours I noticed a significant easing of pain sensations in the area of concern, and I have reduced my pain killer intake by 50%, and will cut it down to zero in another week to ten days. This happened in only five days of one 30mg pill a day. A miracle for me.

Cymbalta Approved for Fibromyalgia

Eli Lilly said Monday that its antidepressant Cymbalta (duloxetine) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia, a chronic disorder with symptoms including widespread muscle pain and tenderness.

The condition affects about 2 percent of the American population, or about 5 million people, mostly women. While its cause is unknown and there is no known cure, it's believed it may be related to a combination of changes in brain and spinal cord chemistry, genetic factors, and stress, the company said in a statement.

Cymbalta affects production of two naturally occurring brain substances, serotonin and norepinephrine. In addition to affecting mood, it's believed these substances are part of the body's natural pain-surpressing system, Lilly said.

In a pair of three-month trials involving 874 people with fibromyalgia, Cymbalta significantly reduced pain levels, compared with a non-medicinal placebo, the company said. Common adverse reactions included nausea, dry mouth, constipation, decreased appetite, and sleepiness.

Cymbalta also is approved to treat major depressive disorder and generalized anxiety disorder, and a form of nerve pain in diabetics, all in adults 18 and older.

The pain is gone. It took around 3 1/2 weeks to 'kick in' fully. Most days are great. I can work again. I can play with my kids again. I'm living again. Cymbalta worked for my fibromyalgia pain when nothing else would.

I share the same experiences as other reviewers. Fibromyalgia was finally diagnosed 10 years ago. I started taking Cymbalta one year ago and it has been a life changing event. It allowed me to get off the two opiate pain medications I was on. No need to tell anyone the impact it has on my life. It's a priceless medicine.

Cymbalta Approved for Chronic Joint and Muscle Pain

Cymbalta (duloxetine hydrochloride) has received expanded approval from the U.S. Food and Drug Administration to treat chronic musculoskeletal pain, stemming from conditions including lower back pain and osteoarthritis.

Since its approval as an antidepressant in 2004, some 30 million people in the United States have used the drug, the agency said in a news release. The FDA also has sanctioned Cymbalta for diabetic pain, generalized anxiety disorder and fibromyalgia.

The most common side effects from Cymbalta use include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. More serious adverse reactions have included liver damage, allergic reaction, pneumonia, depressed mood, and suicidal thoughts and behavior, the agency said.

This drug is fantastic. I had neuropathic pain and depression, due to the chronic pain, for over six months. I tried NSAIDS and other drugs which did little, if anything. Cymbalta really saved me. I tolerated it well and had few side effects, dry mouth and a little wired for the first week on it but that was it. It did reduce sexual performance and cause difficulty with orgasm, but it was worth it. After 10 months I got off of it and everything returned but the pain.
Cymbalta provided amazing relief for my neuropathic pain and depression though it also seemed to have bad side effects. The night terrors I experienced were unimaginable and occurred almost nightly. I had taken this medication for over a year and after choosing to discontinue it, the withdrawal symptoms that followed seemed severe. I would advise a cautious approach.
 was originally prescribed Cymbalta for relief of pain caused by neuropathy in my leg. I have bipolar disorder. At the time I was unaware it was an anti-depressant. Bipolar patients should monitor themselves for symptoms of mania while taking Cymbalta. I was thrown into a wild episode of mania within 3 weeks of taking a 60 mg dose of Cymbalta.

Cymbalta Might Ease Chemo-Linked Pain

Cancer patients on certain chemotherapies often experience a painful tingling in their extremities called peripheral neuropathy, and a new study suggests the antidepressant Cymbalta may be the first treatment to work against the condition.

In the small study, 59 percent of patients who'd experienced peripheral neuropathy said that they gained relief after taking Cymbalta (duloxetine), compared to 39 percent who took a "dummy" pill.

Taking Cymbalta daily "decreases chronic chemotherapy-induced neuropathy and pain severity in the majority of patients who take it and it improves function and quality of life," said study author Ellen Lavoie Smith, an assistant professor at the University of Michigan's School of Nursing. She said the drug is also "very well tolerated" by most patients.

Smith spoke at a news briefing Sunday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The findings were to be formally presented Monday.

One expert was also encouraged by the findings.

"Patients undergoing chemotherapy have to face a multitude of changes, both physically and mentally, and improving their quality of life during this phase of their lives is of utmost importance," said Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City. "It is extremely exciting that there is now a drug we can offer that can reduce this terrible side effect and make chemotherapy more tolerable."

Chemotherapy-induced peripheral neuropathy involves a tingling and numbness in the hands and feet, and is a common side effect of chemotherapies such as the platinum-based medications or taxanes (drugs such as Taxol or Taxotere). It is estimated that up to 30 percent of patients who receive these medications experience neuropathy, and the side effect is a contributing factor to patients dropping treatment.

In the worst cases, "some patients endure this painful neuropathy for months and possibly as long as years following completion of therapy," Smith said. "So it's chronic, it's very distressing and disabling, and then in addition there's really nothing to date that we know is effective in treating the problem."

The new study, funded by the U.S. National Cancer Institute, involved 231 cancer patients who had developed peripheral neuropathy after taking either the platinum-based cancer drug oxaliplatin or the taxane paclitaxel (Taxol). They were randomly assigned to receive either a half-dose of Cymbalta starting at 30 milligrams (mg) per day for the first week, then the full, 60-mg dose for another four weeks; or a placebo pill for five weeks.

According to Smith, Cymbalta is thought to help ease neuropathy by altering levels of brain neurotransmitters linked to nerve function. The drug is already used to treat diabetic peripheral neuropathy, the study noted.

The study found that more patients taking Cymbalta were more likely to report a decrease in neuropathic symptoms compared to those on the placebo. Smith added that "33 percent of patients in the duloxetine group had at least a 30 percent decrease in pain and 21 percent of patients had at least a 50 percent decrease in pain" -- numbers much higher than those on the placebo pill.

Patients taking Cymbalta also "had a greater decrease in the amount that pain interfered with some very important things -- with general activity, with movement, walking, normal work, relations with people, sleep and enjoyment of life," Smith said.

Still, not everyone in the study gained a benefit and some patients actually experienced an increase in tingling/numbness during the trial. However, this was less frequent for those on Cymbalta (11 percent) than on a placebo (28 percent), the authors said.

Cymbalta may come with side effects of its own, notably fatigue, and 11 percent of patients on Cymbalta reported moderate to severe fatigue versus 3 percent of those taking the dummy pill.

Smith said her team is now working on trying to "predict who might respond [to Cymbalta] so that we can target the use of this drug to the people who are mostly likely to benefit."

Another oncologist said he was heartened by these initial results.

"It's true there are not many great treatments for neuropathy, something that is a common side effect of some of the chemotherapy medications that we use for the most common cancers: lung, colon and breast," said Dr. Cardinale Smith, of the division of hematology/medical oncology at the Tisch Cancer Institute and Mount Sinai School of Medicine, in New York City. "This study adds evidence of a medication that appears to have good efficacy in treating what can be a debilitating toxicity."

ASCO spokesman Dr. Nicholas Vogelzang, who moderated the press briefing, said he sees far too much neuropathy in his patients, many of whom receive platinum-based chemotherapy.

I used Cymbalta for a year. The first 8 months were great in alleviating my all-over pain, which is why I was taking it. After that, slowly it came back until I asked to be taken off. In the first few days I had pounding of my heart which was so bad I never slept all night. MD put me on another blood pressure pill which helped after upping the dosage a couple times. After weaning off, heart pounding & insomnia started again.

Lilly Pursues OK for Cymbalta for Chronic Pain

Lilly Pursues OK For Cymbalta For Chronic Pain: Drug maker will take case to treat chronic pain to FDA panel [The Indianapolis Star]

From Indianapolis Star (IN) (August 18, 2010)

Aug. 18--As its pipeline of new drugs continues to sputter, Eli Lilly and Co. is pushing hard to squeeze more uses out of its existing products.

The latest example is Cymbalta, an antidepressant that Lilly hopes to market for chronic pain. On Thursday, the Indianapolis drug maker will make its case before a Food and Drug Administration advisory committee that the drug is a safe, effective treatment for chronic pain, an ailment that affects up to 45 million Americans.

Getting federal approval to market the drug for chronic back or knee pain could add more than $500 million in annual sales, according to Seamus Fernandez, a drug analyst at Leerink Swann & Co. in Boston. Some other analysts say Lilly increasingly needs to get more uses out of its medicine chest.

"Getting another approval for Cymbalta would be very helpful, no doubt about that," said Barbara Ryan, a drug analyst at Deutsche Bank in Greenwich, Conn. "Lilly is not getting anyone excited about its pipeline in the short term."

Cymbalta already is the nation’s fourth-most advertised prescription drug and Lilly’s second-best-selling product, with sales last year of $3.1 billion, up 14 percent from a year earlier. The drug is currently approved for four conditions: depression, anxiety, fibromyalgia and diabetic nerve pain.

But Lilly is making no bones that Cymbalta has room to grow. Lilly’s chief financial officer, Derica Rice, told analysts last year that getting approval for chronic pain would provide "significant growth" that could bring about "a new phase of Cymbalta’s life cycle."

Only one in four people receives adequate treatment for the condition, the company said. The company studied Cymbalta’s use in more than 2,400 patients for chronic pain in 12 late-stage clinical trials.

"We believe it’s important for those patients to have as many different treatment options as possible, because the responses to medicine can be highly individualized," said Dr. James M. Martinez, Lilly’s medical director for Cymbalta.

An FDA staff report released this week concluded that the drug helps people with chronic pain and isn’t linked to any new side effects. No patients died while taking the drug during clinical trials.

Still, some analysts expect the panel to look closely at the drug’s benefit-risk profile. Like all antidepressants, Cymbalta carries a black-box warning for increased risk of suicide among people younger than 25.

"It’s pretty clear that Cymbalta is an effective treatment for depression and for anxiety, but given its safety profile, should it be a widely used medication for pain?" said Robert Hazlett, a drug analyst for BMO Capital Markets in New York. "I’m sure discussion will be had about whether there is good, clear data and how to manage such a risk."

A green light from the FDA would mark the end of a long, bumpy road on the chronic pain indication for Cymbalta. In 2008, Lilly withdrew an application after the FDA questioned the methodology and dosing of some of the company’s trials. The company later submitted a new application, with more data. In January, the FDA canceled a meeting for Lilly’s request, saying it needed more time to review the new information.

And Lilly might approach the FDA again for another proposed use down the road. The company has studied Cymbalta for a raft of other possible uses, including urinary stress incontinence, irritable bowel syndrome and pain associated with multiple sclerosis and breast cancer, according to the web site

The company declined to comment about sales projections or possible future uses of Cymbalta. Nor did it say whether it expects to get FDA approval.
Cymbalta provided amazing relief for my neuropathic pain and depression though it also seemed to have bad side effects. The night terrors I experienced were unimaginable and occurred almost nightly. I had taken this medication for over a year and after choosing to discontinue it, the withdrawal symptoms that followed seemed severe. I would advise a cautious approach.

Fibromyalgia Symptoms

Fibromyalgia can cause pain and stiffness in the muscles and joints almost anywhere in the body, including the trunk, neck, shoulders, back and hips. People often have pain between the shoulder blades and at the bottom of the neck. Pain may be either a general soreness or a gnawing ache, and stiffness is often worst in the morning. Typically, people also complain of feeling abnormally tired, especially of waking up tired, although they have slept well. People with fibromyalgia also have tender points, which are specific spots on the body that are painful to touch. Some people report symptoms of irritable bowel syndrome, depression, anxiety and headache. For research studies, the American College of Rheumatology (ACR) has established criteria for fibromyalgia. To meet these criteria, one must have at least 3 months of unexplained, body-wide pain and at least 11 of 18 tender points in specific locations.

After asking about your symptoms, your doctor will check for swelling, redness and impaired movement in parts of your body where you're having pain. Your doctor will check for tenderness and pain in the ACR-designated tender points.

Your doctor will ask detailed questions about your medical history and examine you to rule out other conditions or diseases that could explain your symptoms.

Because the ACR criteria were developed for research studies, physicians who are not participating in research often diagnose the illness without meeting these strict criteria, but only after they have been unable to find alternative causes of the pain and fatigue.

I have been on Cymbolta for 8 weeks, I suffer from medical anxiety. I have not felt this good in years. the first 2 weeks I did have a lot of side effects swetting, dizziness, insomnea, upset stomach, but after that I started feeling better. I have lost 20 lbs because I no longer feel hunger all the time. I feel like I did 20 years ago so much happier. I can't rave enough about it.
Cymbalta I felt more like myself (Unlike Welbutrin)and it made me FOCUS more at school/work. The cons to the drug,(had to wait 3 days to fill my prescription)thus if you quit cold-turkey, you could have severe brain zaps (it feels like an electrical current running through your brain and it occurs a few times per hour when the withdrawals begin). Also it didn't give me a burst of energy like Wellbutrin did, but Cymbalta made me feel more emotional towards others(rather than being numb to world)


People with fibromyalgia have widespread pain, aches and stiffness in muscles and joints throughout the body along with unusual tiredness. There is no known cause of fibromyalgia. In addition, doctors can't find a physical reason for the symptoms. Blood tests, X-rays and other tests usually are normal in people with fibromyalgia.

Fibromyalgia is a controversial illness. Some physicians don't believe that it's a medical illness but may be a reflection of psychological distress or stress. However, there's no proof of a psychological cause either. Until we have a better understanding of the disorder, it's likely to remain controversial.

It may be that fibromyalgia has more than one cause. Some researchers have suggested that it's related to abnormalities in a non-dream part of the sleep cycle or to low levels of serotonin, a brain chemical that regulates sleep and pain perception. Other theories have linked fibromyalgia to low levels of somatomedin C, a chemical related to muscle strength and muscle repair, or to high levels of substance P, a chemical that affects the threshold at which a person experiences pain. Still others have cited trauma, blood-flow abnormalities in the muscles, viral infections or other infections as possible triggers of fibromyalgia.

Fibromyalgia affects an estimated 3.4% of women and 0.5% of men in the United States, or 3 million to 6 million Americans. It most commonly affects women of childbearing age or older. In fact, some estimates suggest that more than 7% of women in their 70s have fibromyalgia. Many people with fibromyalgia also have psychiatric problems such as depression, anxiety or eating disorders, although the relationship between them remains unclear.
After reading about others' experiences with Cymbalta, I was very hesitant to try it. However, I got to a point where I was willing to do anything to feel 'normal' again. I started Cymbalta (30mg) about 3 months ago and I am SO glad I did. The first week was unpleasant -- I was close to stopping it, but my family encouraged me to give it a fair shot. By the second week things were better. Now (still on 30mg) the only side effects that remain are loss of appetite (causing weight loss), occasional vivid dreams, and some difficulty with orgasm. For me the benefits have been huge -- I am able to focus, more energy, no more racing thoughts, no more crying spells, and no more anxiety/panic. Everyone is different, but for me this has worked great!

FDA approves antidepressant Cymbalta for treatment of pain caused by diabetic peripheral neuropathy

Eli Lilly announced that the FDA has approved the antidepressant Cymbalta (duloxetine HCl; pronounced SIM-BALL-TA), judging it safe and effective for the management of diabetic peripheral neuropathic pain, a symptom of nerve damage that affects up to 5 million Americans.

Cymbalta, a balanced and potent serotonin and norepinephrine reuptake inhibitor, is the first and only FDA-approved treatment for pain caused by diabetic peripheral neuropathy. This approval came after a six-month priority review. More than 18 million Americans have diabetes and are at risk for developing persistent pain -- often described as burning, stabbing or shooting pain -- as a result of nerve damage believed to be caused by high blood sugar.

On August 3, the agency approved Cymbalta as a treatment for major depression in adults. It is available immediately by prescription in pharmacies across the United States for the treatment of major depression or pain associated with diabetic peripheral neuropathy.

Lilly proved Cymbalta's safety and efficacy in the treatment of pain caused by diabetic peripheral neuropathy at doses of 60 and 120 mg per day in two randomized, 12-week, double-blind, placebo-controlled, fixed-dose studies in non-depressed adults who had the disorder for at least 6 months. However, doses of 120 mg per day, although safe and effective, were not as well tolerated as 60 mg per day. On average, patients in the studies were 60 years old, suffered from diabetes for 11 years and from related diabetic neuropathy for four years, and at the beginning of the studies, rated their pain as moderate to moderately severe.

In both studies, Cymbalta significantly reduced 24-hour average pain, compared with placebo. Improvements were noted as early as the first week of treatment and continued for the duration of the studies. In addition, Cymbalta showed rapid onset of action and sustained effect in reducing pain caused by diabetic neuropathy at both 60 mg per day and 120 mg per day, and was effective in relieving pain at night. Nighttime pain is especially troublesome to many patients with diabetic neuropathy, because it can interfere with sleep.

"Until now, we didn't have a simple and effective therapy for patients living with diabetic neuropathic pain. Instead, we were left with medications that often required multiple dose adjustments, or for patients to take several pills throughout the day. This is difficult for many of these patients, as they already take a host of medications for their diabetes and other conditions, which can put them at increased risk for drug interactions and dose-limiting side effects," said Timothy Smith, M.D., R.Ph., Medical Director, Mercy Health Research, St. Louis, and a Cymbalta investigator. "With Cymbalta, we finally have a therapy proven to provide real relief for many of these patients, without the complicated dosing schedule."

Although Cymbalta does not change the underlying nerve damage caused by diabetic peripheral neuropathy, it does help relieve the stabbing, burning and shooting pain often associated with the disorder. Scientists believe it does this by increasing levels of serotonin and norepinephrine, two neurotransmitters, or chemical messengers, believed to be important in regulating a person's emotions as well as sensitivity to pain. Increasing these levels in a balanced way is thought to improve the body's natural ability to regulate pain.

"We know that Cymbalta as an antidepressant is effective at treating both the emotional and painful physical symptoms of depression," said Stephen Stahl, M.D., Ph.D., chairman of the Neuroscience Education Institute and adjunct professor of psychiatry at the University of California at San Diego School of Medicine. "Seeing significant benefit in diabetic neuropathic pain, among patients who did not have depression, helps confirm that this drug has a positive impact on pain that is separate from improvement in mood."
 I want to warn you about watching what you drink and other medicines you take. It turns out that even a little alcohol (3 drinks a month) and Motrin (6 pills taken over one week) will hurt your liver while on Cymbalta. I found this out through a routine blood test.
 Cymbalta has saved my life!! I have been on multiple antidepressants over the last 11 years. I have fibromyalgia/chronic fatigue immune deficiency disorder and if that's not enough to cause depression, I don't know what is!! pain 24/7...I have never felt better! I have been taking it for over a year now and it is still working wonderfully. I'm sorry for y'all's problems with it. but I have been very impressed with it

FDA issues second approvable letter for Lilly's Cymbalta for the treatment of depression

The FDA has issued a second approvable letter for Cymbalta (duloxetine HCl, a potent serotonin and norepinephrine reuptake inhibitor, said Eli Lilly and Company. Approval is contingent upon resolution of manufacturing issues at Lilly's Indianapolis facilities, including a pre-approval site inspection, and the completion of label negotiations.

"This second approvable letter is good news because it confirms that Cymbalta can be approved without any additional studies," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "The successful resolution of manufacturing issues in Indianapolis, and ultimately rebuilding world-class manufacturing and quality capabilities, remains one of Lilly's top priorities."

Lilly received an approvable letter for Cymbalta in September 2002 noting satisfactory resolution of manufacturing issues and label negotiations as the contingencies for approval. On September 3, 2003, Lilly also announced receipt of an approvable letter for another indication for the duloxetine molecule, stress urinary incontinence (SUI). Final approval for the SUI indication is contingent upon successful completion of additional acute pre-clinical and clinical pharmacology studies, satisfactory resolution of manufacturing issues and label negotiations.

Cymbalta is believed to affect the levels of two key neurotransmitters involved in depression -- serotonin and norepinephrine -- both implicated in the complex spectrum of major depression symptoms. Prozac and many other common antidepressants, in contrast, affect only serotonin.

Cymbalta is the best thing that I have ever tried and for more than just depression. I also suffered from debilitating anxiety. Both have all but disappeared. Before I started taking it about 4 months ago I literally hoped I would just fade away. I wanted to die so badly it's all I thought about. I have lost 45 pounds along with my compulsive overeating disorder and have gained more peace and happiness than I ever knew could exist for me. It saved my life (and helped me be a much better mother, wife, daughter-everything). I will deal with the super sweatiness and a few extra yawns during my day in order to have a life. Viva la Cymbalta!

FDA approves Lilly's Cymbalta for the treatment of depression

The FDA has approved Cymbalta (duloxetine HCl; pronounced SIM-BALL-TA), judging it a safe and effective treatment for major depressive disorder, Eli Lilly and Company announced today.

Cymbalta, a balanced and potent reuptake inhibitor of serotonin and norepinephrine, has been studied in more than 6,000 adults with major depression worldwide. Its approval gives healthcare professionals and patients a long-awaited new option for treating the broad range of emotional and physical symptoms of depression. Today, only 25-35 percent of patients treated for depression in clinical studies experience relief from all of their disease symptoms.

"Depression is a whole-body illness, but most modern antidepressants treat the emotional symptoms, such as crying and sadness, better than they treat the physical symptoms of depression," said Dr. Stephen Stahl, chairman of the Neuroscience Education Institute and adjunct professor of psychiatry at the University of California at San Diego School of Medicine. "Because of its dual action on serotonin and norepinephrine, Cymbalta offers physicians a new opportunity to help patients with depression, particularly those who experience the common physical symptoms of the disease, such as vague aches and pains."

Neurotransmitters are believed to help regulate a person's emotions and sensitivity to pain. Scientists believe that if these neurotransmitters are out of balance, a person may become depressed and be more likely to feel painful physical symptoms. The combination of emotional and painful physical effects of depression can have a tremendous negative impact on a person's quality of life.

"Lilly's leadership in neuroscience and dedication to the treatment of depression is well established," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "Lilly is committed to solving the world's most pressing neuroscience problems, through research programs in Alzheimer's and Parkinson's as well as through our established expertise in depression, schizophrenia, bipolar disorder and Attention-Deficit/Hyperactivity Disorder."

Lilly demonstrated Cymbalta's effectiveness in treating major depression with data from four placebo-controlled clinical studies, all in adults. The safety and efficacy of Cymbalta in children have not been studied.

Milt Meyers, a participant in a Cymbalta clinical trial, found it worked for him. "Cymbalta worked for me," Meyers said. "I felt really good for the first time in a long time. I really felt like I was on the right track."

Cymbalta comes in a capsule and can be taken once a day. In clinical trials, Cymbalta was studied in a dose range of 40-120 mg per day. The recommended daily dose is 60 mg.

Duloxetine hydrochloride also is being studied for the treatment of stress urinary incontinence and diabetic neuropathic pain, conditions believed to respond to treatment with both serotonin and norepinephrine.
The Cymbalta took about three weeks to kick in. The side effects started out really strong; dizziness, sweating, no appetite, sleepiness, dry mouth. Now I've been on one month and all of my side effects are gone. I don't have any sexual side effects. As far as treating my depression it's amazing. It's like the light has been turned on again and I can see the good in life. Advice; if you're prescribed this medication, give it a good try - the side effects do diminish. From what I see here, it seems like this works for a lot of people.

Generalized Anxiety Disorder

In generalized anxiety disorder, a person has frequent or nearly constant, nagging feelings of worry or anxiety. These feelings are either unusually intense or out of proportion to the real troubles and dangers of the person's everyday life.

The disorder is defined as persistent worry every day or almost every day for six months or more. In some cases, a person with generalized anxiety disorder feels he or she has always been a worrier, even since childhood or adolescence. In other cases, the anxiety may be triggered by a crisis or a period of stress, such as a job loss, a family illness or the death of a relative. Although the crisis eventually goes away and the stress passes, an unexplained feeling of anxiety may last months or years.

In addition to suffering from constant (or non-stop) worries and anxieties, people with generalized anxiety disorder may have low self-esteem or feel insecure because they see people's intentions or events in negative terms, or they experience them as intimidating or critical. Physical symptoms may lead them to seek treatment from a primary care doctor, cardiologist, pulmonary specialist or gastroenterologist. Stress can intensify the anxiety.

Experts believe that some people with this disorder have a genetic (inherited) tendency to develop it. The disorder probably stems from how a variety of brain structures communicate with each other as they manage the fear response. Chemical messengers, gamma aminobutyric acid (GABA) and serotonin, transmit signals along the circuits connecting brain regions. The medications used to treat anxiety affect these chemicals.

About 3% to 8% of people in the United States have generalized anxiety disorder. Women have the problem twice as often as men. The average adult patient first seeks medical attention between the ages of 20 and 30. However, the illness can occur at any age. Generalized anxiety disorder also has been diagnosed in young children, teenagers and elderly people. The illness is the most common anxiety disorder affecting people age 65 and older.

Of all psychiatric illnesses, generalized anxiety disorder is the least likely to occur alone. Between 50% and 90% of people with the disorder also have at least one other problem, usually panic disorder, a phobia, depression, dysthymia (a less severe form of depression), alcoholism or some other form of substance abuse.
To be diagnosed with generalized anxiety disorder, a person has to have at least three of the following symptoms:

Feeling restless or keyed up

Becoming tired very easily

Having difficulty concentrating or remembering (your mind goes blank)

Feeling irritable, crabby or grouchy

Having tense muscles

Having trouble falling asleep or staying asleep, or not feeling rested after sleep

People with generalized anxiety disorder also may have a wide range of anxiety-related physical symptoms that may seem like symptoms of heart disease, respiratory illness, digestive diseases and other medical illnesses.
You may consult a primary care doctor first if you suspect your physical symptoms are part of a medical illness. Your doctor may do tests to check for medical problems. If the results are normal, your doctor may ask about your family history, your history of any mental distress, current anxieties, recent stresses, and daily use of prescription and nonprescription drugs. Some drugs can cause anxiety symptoms. The doctor then may refer you to a psychiatrist for care.

Your psychiatrist will diagnose generalized anxiety disorder based on a full psychiatric evaluation that includes:

Asking you to describe your worries, anxieties and anxiety-related symptoms

Determining how long you have had these symptoms

Assessing how worry and anxiety have affected your ability to function normally at home, at work and socially

Checking for symptoms of other forms of psychiatric illness that might be present at the same time as generalized anxiety disorder. Symptoms of depression are very common in someone with this disorder.

The psychiatrist also may order diagnostic tests, if necessary, to check for a medical illness. These won't be needed if they already have been done by the doctor who referred you to the psychiatrist.