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Pfizer, Neurocrine Sleeping Pill Denied; Shares Fall (Update4)

2006-05-22T04:27:00.000-07:00

May 16 (Bloomberg) -- A new sleeping pill by Neurocrine Biosciences Inc. and Pfizer Inc. failed to win U.S. regulatory approval, sending shares of the biotechnology company to their lowest price in almost four years.

The Food and Drug Administration had further questions about the medicine in two doses and considered a larger, extended- release dose ``not approvable at this time,'' San Diego-based Neurocrine said today in a statement. The company was expecting a final decision today on approval.

Sales of the insomnia drugs Ambien, made by Sanofi-Aventis, and Lunesta, produced by Sepracor Inc., fell after widespread reports in the U.S. attributing incidents of binge eating and driving while asleep to Ambien. U.S. Representative Patrick Kennedy, Democrat of Rhode Island, said he took Ambien and a nausea drug before wrecking his car earlier this month.

``The FDA watches television and sees people running off the road on Ambien and decided to really be stringent, and that probably delayed things,'' said Les Funtleyder, health-care strategist at Miller Tabak & Co. in New York.

Neurocrine's indiplon is in the same class of drugs as top- selling Ambien and is Neurocrine's most advanced experimental product. The drug is a potential competitor for Lunesta, which won U.S. approval in 2004, Ambien and Takeda Pharmaceutical Co.'s Rozerem. Indiplon has potential sales of about $1 billion worldwide by 2010, Funtleyder said.

Shares

Neurocrine stock fell $29.65, or 54 percent, to $24.98 at 10:27 a.m. in Nasdaq Stock Market composite trading, meaning the company has lost more than $1 billion in market value. Pfizer's shares fell 12 cents to $24.86. Shares of Sepracor rose $5.13, or 11 percent, to $49.95.

Shares of Dov Pharmaceutical Inc., a partner with Neurocrine, fell by $3.60, or 51 percent, to $3.45.

Neurocrine and Pfizer will request a meeting with the FDA within 10 days to discuss what information the agency needs in order for the company to resubmit the application, said Gary Lyons, Neurocrine's chief executive officer, on a conference call with investors. He said the company doesn't have a timeline for when the drug may be approved.

``This wasn't an event we were expecting,'' he said.

Neurocrine said it received a so-called ``approvable'' letter from the FDA on 5 mg and 10 mg capsules. Such a letter usually indicates that certain questions must be resolved before the FDA will grant approval. The 15 mg extended-release tablets were rejected.

Previous Setback

This is a second setback for Neurocrine this year. In March, the company abandoned development of a multiple sclerosis treatment that was in the second of three stages of trials usually needed for U.S. regulatory approval. Tests showed it didn't work.

The FDA delayed approval of indiplon in December, saying that the 475,000-page electronic application Neurocrine filed was too hard to read.

The agency indicated that it didn't have a chance to review all the information submitted as part of the application, Neurocrine said in its statement. The company agreed to talk with the FDA ``to clarify and determine the next steps required to move toward full approval,'' according to the statement.

The company gave no details on the discussions.

Pfizer, the world's biggest drugmaker, agreed in 2002 to pay as much as $400 million for rights to sell the medicine with Neurocrine.

Sleeping Problems

FDA spokeswoman Kimberly Rawlings didn't return two telephone calls seeking comment. Pfizer said it is directing all media calls to Neurocrine.

As many as 25 percent of Americans have occasional sleeping problems, according to the National Institutes of Health. For 10 percent, insomnia is chronic, causing problems carrying out daily activities.

The number of prescriptions for sleeping pills fell in the U.S. in March after news reports about Ambien. New prescriptions dropped 11 percent for Ambien and 4.2 percent for Sepracor's Lunesta in the two weeks after the New York Times reported the rare side effects, according to health-care market researcher Verispan LLC.

To contact the reporters on this story:
Juliann Walsh in New York at jwalsh10@bloomberg.net.
Shannon Pettypiece in Washington at
spettypiece@bloomberg.net

source: http://www.bloomberg.com/

Adv

2006-05-22T04:20:00.000-07:00

Weighing in on obesity

2006-05-15T17:08:00.000-07:00

Comments excerpted here were heard on WLRN-Miami Herald Radio on Tuesday.

Two health professionals and a man battling to lose more than 300 pounds were among those who describe how the national epidemic touches lives in South Florida.

Phil Latzman: Desonta, you write about the fact that obesity is more painful in these areas, in subtropical areas like South Florida than in colder climates. Why do you suppose that is a little bit more of an issue here?

Desonta Holder: Here it is humid and you want to wear fewer clothes than you would in, say, Minnesota where it's frigid in the winter. Here you go to the beach; you occasionally see models here. Everyone wants to look good here in South Florida.

Latzman: You've written about studies the Centers for Disease Control and Prevention shows that the fastest growing segment of all Body Mass Index categories was adults with Class 3 obesity -- also called morbid or extreme obesity. It really is sort of alarming to see that the percentage of obese Americans has gone up at such a fast rate.

Holder: Yes, it is alarming. Actually the percentage of overweight Americans has been constantly increasing since 1970. Some people might say this is a result of technology: We don't have to move around as much as we had to in the past. Also, look around, you see fast-food restaurants everywhere. It's more convenient to drive through McDonald's than it is to go to a supermarket, buy healthful foods, go home and cook. You could say as a result of the hectic lifestyles that people are now leading is causing obesity in America.

Latzman: Looking at the implications of this, people [who] are obese seem to have lower incomes, they're less likely to hold managerial jobs, their spouses generally earn less than non-obese people, they inherit less wealth. This is more getting to a real socio-economic impact. More than anything else right now it really is becoming expensive for people that are obese and even people that are not.

Holder: Yes, actually it's another form of discrimination . . . This discrimination transcends race and gender and it has carried over into the workplace.

JOSE OJEDA

HIS GROCERY BILLS

TOPPED $800 EACH WEEK

Latzman: We have in the studio with us Jos�© Ojeda. In The Miami Herald, he has been keeping a journal [each Tuesday in Tropical Life] recounting his struggle with obesity and his attempts to lose 300 pounds. We welcome you now, Jos�©. So how are you doing?

Ojeda: Actually I'm doing great. To be honest with you, I'm working hard and I'm walking more than two miles every day. Before, when I started, I got on the treadmill at 30 In a Hurry Fitness for 10 minutes, and my tongue was out. I would walk a half a block and I'd be dead.

Latzman: You started out at 520 pounds. What's the number now?

Ojeda: The number now is 434.

Latzman: That's almost 90 pounds. You said back in January when you started this journal [each Tuesday in The Miami Herald], for those who have been keeping track, that you were just tired of being big. You, in fact, were the captain of your basketball team in high school and anybody that's ever played basketball knows how much cardiovascular activity and how you really have to be in shape. What happened since high school? You weighed 170 pounds.

Ojeda: I got married to my first wife, and problems came. Then a few years later, my father died. Then afterward, stress and other problems. Then my mother died. I got real depressed, and I found this wonderful lady, my second wife, Christina. She told me something . . . that really got me thinking: How could I love her if I didn't love myself? And that's very true.

Latzman: I understand that your grocery bill topped $800 a week. What did you spend it all on?

Ojeda: The grocery bill included restaurants and bringing food to the house. I had three refrigerators and one freezer. I had all kinds of meat, lobster, shrimp, whatever.

Latzman: How much would you actually eat per meal, per sitting? What was a typical meal like for you?

Ojeda: I had no specific time to eat. At three in the morning, I would tell my wife to cook me a big steak with rice and beans, and I would eat it. Go to sleep, wake up do whatever I had to do, and then have a big breakfast. I'm talking about six or seven eggs, bacon, sausage, the works. And also drinking a lot of sodas.

DR. MAGALY RODRIGUEZ

SURGEON ADVISED OJEDA TO USE DIET, EXCERCISE, MEDICINE

Latzman: Dr. Rodriguez, tell us how you came to know Jos�©.

Rodriguez: Jos�© came to see me several months ago with his morbid obesity. He was very frustrated when he came to see me, and almost immediately he said he just couldn't go on as his lifestyle wasn't progressing. He had deterioration in all of his activities. When I spoke with him originally, I asked him, what have you ever done to lose weight? He told me that he had never really attempted a serious weight-loss program.

I do laparoscopic surgery, which is gastric bypass. But to try to lose weight with Jos�©, I spoke to him about first doing an intensive treatment to try to lose weight with diet, exercise and also with Meridia, which is a medication approved by the federal government for weight loss. [Editor's note: Meridia, a prescription drug, works on the central nervous system to help patients feel full. It's intended for people who need to lose 30 or more pounds.]

Latzman: So Jos�©, you came to Dr. Rodriguez and said that you wanted to have the surgery, to clip your stomach, essentially, so that you wouldn't eat so much. What did the doctor tell you?

Ojeda: She told me that she couldn't do it because I still smoke. That's my second challenge. She also said that I would have to be six months without smoking because it's very dangerous to do that operation.

Latzman: Who is and who isn't eligible for the procedure? Jos�© mentioned that he is not eligible because he smokes and you wanted to see him lose weight on his own, but who are the best candidates for this?

Rodriguez: The best candidate is somebody who is between the age range of 18 and 50 because these are people who are still young enough. Even if they do have hypertension or diabetes, it hasn't taken a toll on their bodies so that it's not irreversible. After you reach 50 years of age, hypertension has already taken a toll on your heart and your kidneys, so that those changes will not be fixed by the surgery. So you have to be young.

Most of the patients that I have seen are already diabetics, they are already hypertensive, they already have back problems, they have problems sleeping at night with sleep apnea and they snore. So those are people that once you do the surgery, they lose the weight.

For the most part, you do see a significant improvement, especially in their diabetes and their sleep apnea. You also want to see somebody who has tried at least for six months of a directed weight loss program with a physician -- in other words, with diet and exercise, or even with medication -- that needs to be logged down.

Latzman: Research indicates that there could be a virus that causes obesity in much the same way that some viruses cause weight loss and it's possible there are genetic reasons why certain people are obese. Do you buy into that?

Rodriguez: I don't think it's so much a viral condition. I think you'd probably see the situation spreading through North America, South America and Europe.

We know that in developed countries will be some years of major problems. I do believe that there is a certain genetic predisposition and also our lifestyle. The fact that we have a lot of stress in our life. We know that the stress creates certain hormonal changes in our bodies -- shuts down certain hormones while it stimulates other ones to take an effect, which kind of creates a sense within our own bodies that we need to maintain a certain reserve of fats or cholesterol in case we do need it. As in our fight or flight . . . We live with much more stress now than our parents did or our grandparents.

Latzman: In Jos�©'s case, Dr. Rodriguez, where do you see him say a year from now? Where would you like to see him?

Rodriguez: He's doing great. I think that he is so motivated especially because of shows like this and . . . the constant attention that he is receiving from society as a whole. It's a very positive reinforcement for him to continue with his diet, his exercises. He's right on schedule to be losing from 100 to 120 pounds within two years. He's already lost about 100, and it's only been six or seven months. . . . He's just doing very, very well. He's a great example for everybody to follow.

Latzman: I guess there's a chance that you may never perform that laparoscopic surgery on Jos�©. Is that what you're hoping?

Rodriguez: For sure. We know that bariatric surgery is a great surgery and it's a wonderful solution for a great majority of people. We know that it works. After the surgery, they lose the weight, but they're still not happy because all of a sudden, they have other issues to deal with. You have to slowly change your mind, change your body to accommodate what's going on.

CLAUDIA GONZALEZ

'GORDITO' DOES NOT

MEAN 'HEALTHY' ANYMORE

Latzman: [Claudia, in your book, you say] that in the Latino culture, ''a fat baby is considered a healthy baby.'' Why is there that perception that being overweight is healthy?

González: When a Latino mother actually goes to the doctor and the pediatrician will measure the child or the baby, it will be probably higher than 50 percent in terms of height and weight, and actually the mother will be very happy. She will say, ``Oh my God, I'm feeding my baby. I'm a good mother because chubby babies relate to being a good mother.''

I'm a mother of three and I breast-fed my babies for one year, and I remember my mom telling me that you need to get formula, they're hungry, they need to be fed more. So we have that culture that we have to overfeed our babies. That's what I'm trying to tell mothers in my book: Gordito is not healthy anymore.

Latzman: And, anyone who has had a Jewish grandmother probably knows that as well. In any culture, that is the perception because maybe hundreds of years ago, food was, as you explained in the book, harder to come by, and the more excess baggage you had it was perceived that you had a better chance to survive.

González: What happened is that it has changed. We have so much food all around us. Now we have to make the decision not to eat that much because we don't go hungry anymore like before.

Latzman: What makes Latinos as opposed to maybe some other ethnic groups more susceptible to obesity?

González: Different studies actually discuss [whether] we may have a gene that makes us more obese than any other group. And, also it's a cultural thing. Our foods in Latin America actually are healthier, but when we come to this country, it's like we become a little confused. What is it that I have to do? Is it going to be American food, is it going to be my food? We lost something in between. What I'm trying to tell them is you have to find a balance between your culture and the American way.

Latzman: Explain the Latin food pyramid.

González: Basically, the USDA pyramid doesn't address the way that Latinos eat. For example, we eat a lot of carbohydrates. In the USDA pyramid, you will find that the potatoes or yucca or malanga, what we eat here, actually are in vegetable group. We tend to [use] them as carbohydrates.

Let's talk about the typical Cuban plate. It will have the beans, rice, yucca, plantains, and that actually doesn't count as the really green vegetables. So that's why I kind of redefine all the foods.

Latzman: When you sit down and talk to families, Claudia, what do you recommend to them about their diets and how to change their diets. What's your best advice?

González: When I have a child as a patient, . . . I usually tell [their parents] to be very patient. They have to set an example and to [visualize] that child as an adult because what happens is, it takes time. It takes effort, and sometimes we live in, like, a microwave. Like I want it for today. So what happens if I want my 5-year-old to be a healthy child? I have to start now, and it may take five or 10 years. But the thing is for him or her to become a healthy adult. It may take years, but it will make a difference, whatever you do in terms of making healthy choices.

THE CALLERS

FOOD AS AN ADDICTION; MAKING HEALTHY CHOICES

Caller: Lynne Vainberg (a program assistant in University of Florida's Cooperative Extension program. Vainberg teaches at the Caridad Clinic of Boynton Beach, operated by the Migrant Association of South Florida): We have cooperative extension to the University of Florida Family Nutrition Program, and this is so important. We work with healthy food choices, obesity and diabetes risk. We work very closely with the Latino population. I give several classes at Caridad Clinic with families because if we try to make healthy, nutritious changes through the kids we don't always change the parents. If we work with the parents, it's hard to change the kids. So we've been making wonderful, wonderful changes with the family at Caridad Clinic, and our program teaches healthy food choices, cutting the fat, reading food labels . . .

We've also done studies at the University of Florida that shows how Mexicans come to the States much healthier with their nutrition, and the longer they're in the States, the worst their nutrition gets, whereas Puerto Ricans and some Cubans and Dominicans get healthier the longer they're here. It's a very interesting study.

González: I think that it's happening to every group. In terms of my book, I had to study what's happening to Latinos, but basically it's happening all over the place.

Caller: Steve: I just wanted to address overeating as an addiction. I know that you all have focused mainly on it as a lifestyle consequence of eating too many calories that one can't spend through exercise and other lifestyle things, but it sounds like from hearing some of Jos�©'s background that he had emotional stuff going on that triggered the onset of serious overeating, which is very similar to how an alcoholic becomes an alcoholic, how a drug addict becomes an addict. They are responding to things in their life and using these things as crutches and granted that in our society with our advances in technology and fact food and what not. There are obviously a lot of overweight people who are not necessarily addicts in the same way that others are, but I believe that overeating as a addiction makes up for a large percentage of the obese people that we see.

Ojeda: Yes, it is an addiction. Food is an addiction. . . . Like my trainer Glen Greer says, there are three components to [losing weight] . . . have productive nutrition, maintain muscles and have productive cardio. I have one more: Find a good guide. I mean with the doctors and with everybody else.

Latzman: Steve are you someone who has lost weight or is addicted to food?

Caller: Steve: Yes, exactly. I've had my own personal struggles with that.

E-mail question: Philip from Fort Lauderdale: Can Claudia González comment on what I call the culture of loss with regard to advertising? Every commercial promises more for less, or are selling the product that boasts losing weight . . . How does this play into the psychology of obesity in a society that's trying to shed while so much of the world lives in near starvation environments?

González: He's right. Everybody is looking for the miracle pill, right? But the thing is that after 30 years, everything has changed. But again, we know that that doesn't work unless you change. You want to have changes -- eating behavior, physical activity and then you may have a pill. Or you may have something else to keep you going, but at the end, it's about you, the changes that you want to make.

Caller: Edwin: I'm from Venezuela, and the U.S. is actually the only country where low-income families or individuals are overweight. In Venezuela, you can know who is in the low-income bracket because they are underweight. So the size here matters. When you can go to a restaurant and buy a hamburger and a Coke and fries for $5, it doesn't mean that that's the best size for you.

Latzman: So you're saying that you come from a country where people know how to eat correctly?

Edwin: Yes. When you're from a country where money is a problem, you definitely learn how to manipulate what you do in order to get a good meal out of it.

González: Definitely . . . In the U.S., food is cheap compared to other countries. It's cheaper than, sometimes, in Latin America. So that's why he was saying in Venezuela you have to have a budget because it's a different economy.

Caller: Chris in Coral Springs: I have a comment. The traditions of eating are like religion and traditions of eating are passed down from generation to generation. In the 1940s and '50s, people worked a lot more than they do now and were a lot more active. I don't believe there's a gene problem at all. It's a tradition problem. People who are Italian eat spaghetti, people that are Mexican eat more beans and more rice . . .

I think it's lack of education. A lot of it is psychology. A lot of it's just laziness for the people in the U.S. because everything is so easy to prepare and a lot of it is lack of exercise, not feeding their muscle and starving their fat. That's a big, big problem in our country. I think a lot of it is people are looking for an excuse to say well, it's not my fault. But when do they take responsibility for that?

Ojeda: What this caller is saying is very true. We're all full of excuses. We find excuses for everything.

Caller: Sally in Miami Beach: I'm a personal trainer and I've been in the industry for about 25 years. We like to try some different things and one of the things that we tried was hiring an instructor with a different body type for people that are maybe having a little trouble with getting started. Sometimes a different body type will be less intimidating, and maybe they can relate to that instructor a little better because they are coming from a similar place.

Latzman: How much, Jos�©, has exercise factored into your efforts to lose this weight?

Ojeda: What I'm trying to do is get the water out of my body. With the exercise, I'm feeling great. [Before], I couldn't put on my socks or tie my shoelaces. Also, I'm full of energy.

Latzman: We have a question by email: ''Jos�© is a great man with a heroic wife and support system. We readers are following his weekly progress and predict that he and his team will taste victory.'' That is from Kenny Schwartz.

Tell us what the response has been to your being in the paper once a week and reporting on the most personal issues.

Ojeda: They start telling me that I'm a celebrity. If I go to 7-Eleven or Publix or anyplace, I find somebody that congratulates me and tell me that I'm doing great and to keep it up.

source: http://www.miami.com/

ReGen Therapeutics Plc - Issue of Equity

2006-05-14T00:34:00.000-07:00

LONDON, May 12, 2006-ReGen Therapeutics Plc ('ReGen' or the 'Company') announces that it has placed through its brokers J M Finn & Co with new and existing shareholders 82,000,000 new ordinary shares at 1p per share to raise £820,000, before expenses ('Placing')

Application will be made for 77,500,000 of these new ordinary shares to be admitted to the AIM Market of the London Stock Exchange Plc and dealings are expected to commence at 8am on 25 May 2006. Application will be made for the balance of 4,500,000 new ordinary shares to be admitted to the AIM Market of the London Stock Exchange Plc and dealings are expected to commence at 8am on 8 June 2006.

Subsequent to the above Placing, the new enlarged share capital of the Company will be 583,304,442 ordinary shares (the 'Enlarged Share Capital').

Mr Peter Garrod, a Director of ReGen, is subscribing for 2,500,000 new ordinary shares in the Placing making his total holding 63,750,000 representing 10.93% of the Enlarged Share Capital.

Executive Chairman Percy Lomax commented, 'The capital raised will be used to fund the proposed Phase IIa trials of zolpidem and development of Colostrinin(TM) for marketing'.

All new ordinary shares will rank pari passu with the existing ordinary shares of 0.1p each in the Company.

For further information, please contact:

Andrew Marshall
Greycoat Communications
Tel. 020 7960 6007
Mobile: 07785 297111

source: http://www.pharmalive.com

Users claim strange behaviors linked to Ambien

2006-05-11T15:00:00.000-07:00

Ainsley Earhardt
KENS 5 Eyewitness News

Ambien is a popular sleeping pill for patients suffering from insomnia. Recently, however, some people have complained about side effects that include weight gain and sleep walking.

John Miller was such a patient. His doctor prescribed Ambien and Miller claims it helped him rest, but that it is also robbing him of his memory and altered his personality.

"I don't like who I was or (what) my personality was back then," former Ambien user Miller said.

One morning, Miller awoke in pain and didn't know why.

"I had cuts and bruises all over my body. Everywhere — on my face, shoulders, neck, arms, legs — everywhere," he said.

Miller says he couldn't remember what happened during the night. Amnesia is a complaint Dr. Chris Tickner says he hears a lot from patients who use Ambien.

"If the phone rings late at night and they answer it, they may not remember the conversation the next day," Tickner said.

Tickner is a San Antonio psychiatrist who claims one in five of his patients taking Ambien has unpleasant side effects.

"Unfortunately, as with most medicines, not every medicine works well for every patient," he said.

Sanofi-aventis is the company that makes Ambien. Each box lists possible side effects and special concerns, including memory problems and changes in behavior and thinking.

"It caused a lot of problems. A lot of embarrassing problems," said one Texas real estate agent. She says her problems were so severe and embarrassing that she does not want to be identified.

"Every morning I would notice something on my nightstand — leftover popcorn or ice cream, bread or snacks or whatever. I was eating a lot," she said.

The woman claims that she gained 70 pounds during the first year she was on Ambien and that the drug caused her to sleepwalk to the kitchen.

"I started cooking in the middle of the night. I would leave the fire on the stove. I'd go back up to sleep and my husband would get up in the morning and the stove would be on," she said. "I baked a cake in the middle of the night and I don't remember that."

The strange side effects the drug can cause are raising safety concerns. The Bexar County District Attorney's Office has about 10 cases of driving while intoxicated in which Ambien was mixed with other drugs or alcohol.

However, First Assistant District Attorney Cliff Herberg says the Ambien excuse would be hard to prove in court.

"It is not a legal defense. There is no defense that I was under Ambien and that caused me to break the law," he said.

KENS 5 tried unsuccessfully to contact the drug maker, but a statement on Sanofi-aventis' Web site says, "Ambien, when taken as directed, provides a safe and effective treatment to millions of men and women coping with insomnia."

The company's Web site says despite recent media reports on sleepwalking and sleep eating, the makers have not observed any significant change in Ambien's safety profile.

However, some who have taken the drug disagree.

Miller says the drug is the trouble. He says he's lucky to be alive, and hopes these stories will provide a wake-up call for others.

"I just would hate to see someone else have a fall or an accident because they weren't aware of what they were doing and have something worse than what happened to me," Miller said.

The two people KENS 5 interviewed for this story are not involved in a nationwide class-action lawsuit against the makers of Ambien. People involved in the suit are seeking compensation for the problems they experienced.

No More Counting Sheep

2006-05-09T13:09:00.000-07:00

Kristen Maxwell

Face it. There isn’t much time to sleep. And when you finally find time, insomnia can hit as tests, papers, deadlines and relationships dance in your head. As a result, many people turn to sleep aids, both over-the-counter and prescription. But some of these aids can be hazardous. Below are some popular ways to cure insomnia — and the truth about their side effects and uses.

Herbal supplements

The active ingredient in some non-prescription herbal sleep-aids is valerian root. It functions not only as a sleep aid but as pain reliever and treatment for depression, exhaustion and anxiety.

Herbal supplements have limited or no side effects and few drug interactions. But Marianne Middleton, clinical coordinator at Lawrence Memorial Hospital Sleep Disorder Center, warns that with herbal medicines, you often don’t know what you are getting.

The Food and Drug Administration doesn’t regulate herbs and the drugs often are not American-made, she says. Therefore, it’s hard to know their strength.

Certain scents such as lavender can be relaxing, and do not have any side effects, Middleton says.

Side Effects: With herbal medicine there are limited to no side effects. However, herbal drugs usually only are effective short-term and there is a slight chance of allergic reaction, as with all drugs. The top three herbal supplements rated by Consumer Health Digest are Somnatrol, Dormías and RevitaSleep.

Ambien and Lunesta

Ambien and Lunesta both use a sedative/hypnotic drug called Zolpidem. It helps you fall asleep faster, stay asleep longer and reduces the number of times you wake up in the night. However, some users recently have reported sleepwalking, which has caused the FDA to be suspicious. Sarah Aylward, Kansas City, Mo., senior and Lunesta consumer, says she has had similar experiences with the drug.

“I’ve had mornings where I’ve woken up and realized that I had gotten up in the middle of the night. I only vaguely remember feeling drugged,” she says.

Side Effects: Stomach cramps, shakiness, flushing, nervousness, nausea and vomiting are all minor side effects of Ambien and Lunesta. Aylward says her most common symptom is feeling groggy in the morning, which has caused her to miss classes.

These drugs are highly addictive and can cause withdrawal symptoms if you quit abruptly. Middleton also warns that taking Ambien or Lunesta with alcohol can have severe repercussions.

Over-the-counter antihistamines

According to the National Institutes of Health’s State-of-the-Science Conference, antihistamines are the most common over-the-counter treatment for insomnia. They are non-addictive and most consumers can handle them.

Side Effects: Higher risk of daytime fatigue and a reduction in cognitive function.

Antidepressants

Originally used as an antidepressant, Trazodone is one of the most popular sleep-aids, according to Consumer Health Digest. It relaxes the mind and relieves anxiety. Christina McCoy, Overland Park senior, takes Trazodone about three times a week. She says she can’t sleep because of anxiety and Trazodone helps. McCoy considers the over-the-counter aid to be safer than its prescription counterparts. “It’s the natural way to go if you’re worried about prescription medication addiction,” she says.

Side Effects: Dizziness, drowsiness, headache, dry mouth, diarrhea or constipation. Serious side effects include allergic reaction, prolonged (four hours or longer), painful erection and irregular heartbeat.

Warm glass of milk

Your grandma’s sleep remedy actually has some truth to it. Middleton says that milk contains tryptophan, which will relax you and alleviate stress.

Side Effects: None, unless you are lactose intolerant.

Consult a physician before using these and any other drugs.

WAYS TO SLEEP BETTER

Retire and rise on a timeline that deviates by no more than two hours every day, even on weekends.

Avoid caffeine, nicotine and alcohol, which suppress deep sleep, within three to six hours, and heavy meals within three hours, of bedtime.

Use your bed for resting or sleeping, not for office work, watching television, or playing video games (unless it helps you to doze off).

Exercise moderately for 30 minutes a day, but no later than three hours before lights out.

Snack on bananas, turkey, peanut butter or other tryptophan-rich foods to enlist the aid of this naturally calming compound.

Nap no later than mid-afternoon to avoid sleep interference.

Write out a "worry list" or "to do list" of bothersome matters before bed to help your mind disengage.

Source: sleepbetter.org

Ambien-Induced 'Sleep Driving' Caused Accident, Says Congressman Patrick Kennedy; He'll Enter Rehab

2006-05-09T12:36:00.000-07:00

WASHINGTON (AP) -- Rep. Patrick Kennedy said Friday he was entering treatment for addiction to prescription pain medication, a decision made after a highly publicized car crash near the Capitol that the congressman said he cannot recall.

Kennedy, D-R.I., said he would seek immediate treatment at the Mayo Clinic in Rochester, Minn.

He announced his decision to reporters at a Capitol Hill news conference. He walked in alone, gripped the lectern, cleared his throat and began haltingly.

Kennedy, who has struggled with addiction and depression, said he had checked into the Mayo Clinic over the Christmas holidays and returned to Congress "reinvigorated and healthy."

"Of course, in every recovery, each day has its ups and downs, but I have been strong, focused and productive since my return," Kennedy said.

The congressman said he again became concerned about his condition after the Thursday morning car accident.

"I simply do not remember getting out of bed, being pulled over by the police, or being cited for three driving infractions," Kennedy said. "That's not how I want to live my life. And that's not how I want to represent the people of Rhode Island."

As he was leaving the room, Kennedy was asked whether he might resign, and he shook his head no. "I need to stay in the fight," he said. He did not take other questions.

Kennedy -- nephew of the late President Kennedy -- was elected to Congress in 1994.

The congressman's father, Sen. Edward Kennedy, D-Mass., issued a statement saying he was proud of his son for admitting his problem and taking steps to correct it.

"He has taken full responsibility for events that occurred ... and he will continue to cooperate fully with any investigation," the elder Kennedy said.

The younger Kennedy said he hoped that his "openness today and in the past, and my acknowledgment that I need help, will give others the courage to get help if they need it."

Kennedy was cited for three traffic violations after his early morning car crash Thursday near the Capitol, according to a police report.

The report by a U.S. Capitol Police officer said Kennedy drove his green 1997 Ford Mustang convertible into a security barrier near the Capitol shortly before 3 a.m. Thursday, and that Kennedy had red, watery eyes, slurred speech and unsteady balance.

Kennedy had said in a statement Thursday that he had taken a sleeping pill and another drug that can cause drowsiness, but had not been drinking alcohol before the accident. "Apparently, I was disoriented from the medication," Kennedy said.

The police report described Kennedy as "ability impaired," and listed alcohol influence as a contributing circumstance in the crash.

Louis P. Cannon, president of the Washington chapter of the Fraternal Order of Police, who was not on the scene, said the congressman had appeared intoxicated when he crashed his car. The officers involved in the accident were instructed by an official "above the rank of patrolman" to take Kennedy home and no sobriety tests were conducted at the scene, Cannon said.

"I never asked for any preferential treatment," Kennedy said to reporters as he left his congressional office Thursday night.

It was Kennedy's second auto crash in three weeks. His car struck the passenger rear door of a second car while Kennedy was making a left turn from a roadway into a CVS pharmacy, according to a police report on the April 15 accident. No injuries were reported in the accident in Portsmouth, R.I., and Kennedy was not cited.

In Washington, Kennedy, 38, told the police officer he was "headed to the Capitol to make a vote," the report said. He was cited for failure to keep in the proper lane, traveling at "unreasonable speed" and failing to "give full time and attention" to operating his vehicle.

Kennedy spokeswoman Robin Costello acknowledged the police report but said in an e-mailed message: "The congressman has not been presented with those traffic tickets."

At about 2:47 a.m., police observed Kennedy's car, with no headlights on, swerve into the wrong lane and strike a curb. Kennedy nearly hit a police car, the report said, and the officer in the cruiser was forced to use evasive maneuvers to avoid a collision.

The cruiser put on its emergency flashers and tried to pull Kennedy over, but the congressman did not respond. He continued at a slower speed before colliding head-on with a security barrier, according to the report.

Capitol Police had no comment Friday beyond a statement posted on their Web site, said spokeswoman Sgt. Kimberly Schneider. That statement said, "The United States Capitol Police are continuing to investigate."

He said that he'd gone home Wednesday evening after work and taken "the prescribed amount" of Phenergan, a prescription anti-nausea drug that can cause drowsiness, and Ambien, a sleep medication. But he said he consumed no alcohol before the crash.

The attending physician for Congress had prescribed Phenergan to treat Kennedy's gastroenteritis, an inflammation of the stomach and intestines. According to the drug's label, Phenergan can increase the effects of sleep medicines such as Ambien.

Ambien comes with a warning to patients that it can cause confusion, strange behavior and hallucinations. Also, it is to be taken only when patients have time for a full eight hours of sleep, allowing its effects to wear off, according to its Food and Drug Administration-approved label.

The congressman was treated at a drug rehabilitation clinic before he went to Providence College and has been praised in the past for his openness.

The following is a previous report from WUSA in Washington, DC

WUSA-Rep. Patrick Kennedy crashed his car near the Capitol early Thursday, and a police official said he appeared intoxicated. Kennedy said he had taken sleep medication and a prescription anti-nausea drug that can cause drowsiness.

He originally issued a statement saying he had not been drinking. But late Thursday, his chief of staff handed out a statement saying he was on a prescribed combination of Ambien -- a sleep medication -- and Phenergan -- an anti-nausea drug.

In his statement, Kennedy said he was treated Tuesday for gasroenteritis and given Phenergran, which can cause drowsiness.

Kennedy was reportedly behind the wheel of a green Ford Mustang when it crashed into a security barrier at 1st and "C" streets Southeast about 2:45 a.m.

No one was hurt, but police say the car nearly struck a Capitol police cruiser and that it had been swerving, as if trying to make a U-turn.

So far, Kennedy has not been charged.

Kennedy said he had returned home after a series of votes on Capitol Hill Wednesday and took "the prescribed amount" of Phenergan and Ambien.

He says sometime around 2:45 a.m., he drove back to the Capitol believing he needed to vote.

"Apparently, I was disoriented from the medication," he said.

He says police told him to park his car and drove him home.

"At no time did I ask for special consideration, I simply complied with what the officers asked me to do."

Earlier Thursday, the Capitol Hill Fraternal Order of Police called for higher-ups in the department to allow patrol officers to complete their investigation into the crash.

The head of the Fraternal Order of Police Lodge 1, Lou Cannon, told W*USA 9 News Reporter Stacey Cohan that he's concerned that Kennedy may have received special treatment and this could be a case where "rank has its privilege."

Capitol police Officer Greg Baird wrote a letter to acting Chief Christopher McGaffin saying how the investigation was handled calls the department's integrity into question.

According to Rollcall.com, Baird -- acting chairman of the Capitol Police Fraternal Order of Police -- said Kennedy's Mustang had its lights off when it narrowly missed crashing into a police cruiser and smashed into a security barrier.

According to Roll Call, Baird wrote in his letter that the driver got out and "was observed to be staggering." He told officers he was a congressman late for a vote. Baird wrote that patrol officers at the scene were prohibited from performing field sobriety tests. Then two sergeants arrived, conferred with a watch commander and "ordered all of the patrol division units to leave the scene . that they were taking over."

Congressman Patrick Kennedy is Ted Kennedy's son. He is currently serving his sixth term as the Democratic Congressman from Rhode Island. He sits on the powerful House Appropriations Committee.

Kennedy spent time at a drug rehabilitation clinic before he went to Providence College. He has been open about mental health issues, including being diagnosed with bipolar disorder.

Source: http://www.ksdk.com/