A generic version is now (OFFICIALLY) available for Ambien® (zolpidem), a widely prescribed sleep aid. Since Ambien lost patent protection on April 21, the price for zolpidem has dropped from more than $4 to less than 25 cents per tablet, or $100 per month to less than $10. The price of Ambien® increased by over 30 percent in the last year. Of course, visitors to this site have been able to buy brand quality generic ambien for years!

“This represents a significant savings for health plans and consumers because prescription sleep aids are one of the most widely used and fastest growing drug classes,” said Richard Bruzek, HealthPartners vice president of pharmacy services. “This doesn’t however, change our main concern which is the appropriate use of drugs by patients, whether brand or generic.”

HealthPartners costs for sleep aids increased 60 percent from 2005 to 2006. About 7,000 HealthPartners members have prescriptions for Ambien®.

“The introduction of this generic will significantly decrease patient and plan expenses for this category of drugs,” Bruzek said. Sixty-seven percent of HealthPartners prescriptions are for generic drugs, an increase of over 15 percent in just three years. Every one percent increase in the use of generic drugs reduces HealthPartners plans and member costs by $7 million annually.

Remember those old American Express commercials in which Karl Malden warned travelers, “Don’t leave home without it” — as if you were going to wind up in a Turkish prison or on the streets of Calcutta if you forgot your credit card?

That advice seems antiquated nowadays, because there’s almost nothing you can’t get abroad.

That’s a good thing to remember when you’re tempted to over-pack. When I hit the road, I pare it down to the essentials:

# A carry-on bag: One piece of luggage in whatever shape and style suits you. It should be big enough for one week’s gear — only. When your clothes get dirty, go to a Laundromat. The bag should conform to airline carry-on regulations so it fits in the overhead bin, but it should also have some give so you can cram it full and check it on the way back. Tuck a sturdy fabric carry-all into a pocket of your main piece of luggage to accommodate acquisitions along the way.

# Medicines, glasses: Make sure you have your prescription drugs and vitamins; pack duplicate supplies in both checked and carry-on bags so if one gets lost you still have your meds. The same is true of eyeglasses and contact lenses.

# Plastic baggies: I am a firm believer in the unparalleled usefulness of zip-lock bags — for wet swimming suits, beautiful beach rocks, leaky toiletries, dirty underwear.

# Sink stopper: Globe-trotters often need to wash intimate apparel in the bathroom sink. Many hotels, mostly at the high end, have leaky
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sink drains. If you pack a flat, rubber drain-stopper, you’ll be happy even at the Ritz.

# Sleep aids: Unless you can sleep anywhere, long-haul flights, jet lag and noisy, unfamiliar hotel rooms can turn you into a zombie. To fight travel insomnia, take earplugs and eye shades. Check with your doctor if you think you need a prescription sleeping pill or want to try something homeopathic.

# First-aid kit: I have a well-used travel medical kit with all the usual suspects: bandages, aspirin, antiseptic. A few other items aren’t as obvious: a mini sewing kit, moleskin for blisters, insect repellent, Tiger Balm (good for achy muscles as well as a smelly loo, when applied underneath the nose) and Uncle Bill’s Silver-Gripper tweezers with pinpoint precision to remove splinters.

# Windbreaker: I rarely go anywhere without an old shell jacket that can keep me dry in a tropical downpour and warm in the Canadian Rockies, when worn with layers underneath. Many companies make these; get an unlined one so it can be wadded up and stuffed into a side pocket of your bag.

# Inexpensive sandals: Cheap rubber flip-flops always come in handy, whether you’re at the beach, showering in a shared bathroom or just kicking back in a none-too-pristine budget hotel room. You can also wear them on the street and pitch them before you leave.

# Little black jacket: This one’s for the girls. Leave home wearing a simple black jacket in a wrinkle-proof synthetic blend and a shawl as part of your travel attire. (Packing them takes up too much space.) The eminently accessorize-able black jacket will be worth its weight in gold, and the shawl can double as a blanket or pillow.

# A cuppa something: Many of us need a jolt of java in the morning, but when it’s unavailable, the caffeine in tea is a welcome substitute, and you can almost always cadge a cup of hot water at a hotel front desk. I keep an assortment of tea bags in a zip-lock bag: herbal to help me sleep, echinacea for when I’m under the weather and black for a boost.

Generic versions have been available from offshore pharmcies for may a year, but now Ambien, the worlds’s favorite prescription sleep aid, is finally out of patent even in the US. In fact, the first generic versions of the insomnia drug Ambien won federal approval Monday.
The Food and Drug Administration said it approved versions of the immediate-release tablets made by 13 drug companies for the short-term treatment of insomnia. A patent held by Paris-based Sanofi-Aventis on the drug, also called zolpidem tartrate, expired Saturday.
The approvals of generic versions of the drug come a month after the FDA asked makers of it and similar sleep aids to beef up warnings about their potential risks. The risks of the sedative-hypnotic drugs include severe allergic reactions and complex sleep-related behaviors, like sleep-driving.
The FDA said Ambien was the No. 13 brand-name drug by sales last year.

According to new research, “night owls” suffer more from insomnia than those who try and get their z’s earlier on.

Night owls also tended to be more concerned about their insomnia than the early-to-bed folks, despite the fact that they actually spent relatively more time in bed and got more sleep overall, the researchers found.

“We suspected that there may be more severe symptoms among night owl insomniacs,” said the lead author, Jason C. Ong, an instructor of psychiatry in the Sleep Disorders Clinic at Stanford University in Palo Alto, Calif. “But we also found they exhibited much more distress about their sleep, in terms of attitude. They felt they needed eight hours of sleep, and they’re not getting it, and that was associated with feelings of depression and irritability and that kind of thing.”

According to the researchers, physiological “insomnia” — which affects 30 percent of American adults — refers to disorders defined by poor sleep quality and difficulties falling and staying asleep.

By contrast, another type of sleep disturbance, known as a “circadian rhythm sleep disorder” (CRSD), can arise when the hours of your natural internal clock do not line up well with your social or professional schedule. The resulting “mismatch” can undermine your ability to fall asleep or wake up.

Traditionally, CRSD has been viewed as distinct from insomnia. Experts have theorized that when circadian rhythms match your daily schedule, you should theoretically experience problem-free sleep.

The new study focused on 312 outpatients (60 percent women) who had already started to undergo group behavior therapy for insomnia at the Stanford sleep clinic between 1999 and 2004.

Ong and his team asked all the men and women to indicate their usual (pre-insomnia) preference for sleep scheduling — when they liked going to bed and waking up.

Based on that information, the patients were characterized as either “morning larks” who felt best going to bed early and rising early, or “night owls” who hit the sack late and slept in. There were also “intermediate” types who fell somewhere in between.

After sorting the participants according to their sleep preference — or “chronotype”- the authors then reviewed week-long sleep diaries that annotated time of lights out, number of awakenings during sleep, time spent out of bed during sleep time, sleep quality, total time spent sleeping, and all sleep-aid drugs consumed.

In addition, a series of psychological surveys were administered to detect depression, frustration and negative beliefs related to either insomnia or sleep in general.

The Stanford team found that night owl insomniacs spent more time out of bed while trying to sleep, and generally experienced more sleeplessness than either morning larks or intermediate type insomniacs.

Night owls also displayed the most erratic bedtime and wake-time habits, and were relatively more depressed and more frustrated by their insomnia. For example, the “owls” expressed more concern than the others about the consequences of insomnia and their inability to control sleep.

They made up for such deficits by choosing to spend more time sleeping. In this way, they actually racked up more total sleep time than the other study participants.

No group differences, however, were found with respect to the number of times patients awoke during sleep, in their use of sleep-aids, or in the quality of their sleep.

The findings applied equally to men and women.

According to Ong’s team, your natural sleeping schedule preference appears connected to the nature of your insomnia. They emphasized, however, that the findings only point to an association between sleep-time preferences and insomnia, rather than any cause-and-effect relationship.

They also cautioned that clinical measures of sleep — such as blood levels of cortisol, melatonin, or changes in body temperature — were not evaluated. Some of the patients also had medical conditions that could have affected their sleep patterns.

Nevertheless, Ong and his colleagues believe the findings could someday lead to targeted treatments that hone in on the patient’s unique “insomnia profile.”

“It would be premature to recommend any particular treatment at this point,” said Ong. “The goal here was to learn from our patients. So this is more of a starting point that will hopefully stimulate more research into this area and help to develop some guidelines. But now we can say that maybe we should consider the idea of tailoring intervention and treating people differently, in light of this association.”

Another sleep expert agreed more research is needed.

“To me this study underscores the urgent need for researchers to take more seriously the kinds of insomnia that people present with,” said Michael L. Perlis, director of the University of Rochester’s Sleep Research Laboratory.

He noted that while some patients have trouble falling asleep, others have trouble staying asleep or waking up too early, or any combination thereof.

“People don’t experience one form of disorder or another for no reason,” he said. “Maybe the reason is related to their chronotype, as is suggested by the Ong study. Maybe it’s related to how people manage their insomnia? These issues need to be worked out, so that we can better define the disease and in so doing develop better treatments.”

Here’s an extract of an interview with Dr. Lisa Williams of Montgomery Pulmonary Consultants. She regularly sees people in sleep labs suffering from sleep apnea and insomnia.

Q. What is sleep apnea?

A: Sleep apnea is a problem of not getting enough air from the upper airways to the lungs during sleep. There is crowding in the back of the throat and the upper neck area. In people with sleep apnea, especially when they sleep on their backs, all the muscles and soft tissue in their necks closes off that airway, and there is not enough oxygen getting from the brain to the heart.

The body compensates by making you wake up. It’s the brain’s way to telling you, ‘I’m not getting enough oxygen.’

Q. Who gets sleep apnea and what are the consequences?

A. There are a lot of risk factors, for instance, any person who has obesity or low thyroid. Neck circumference is also a factor. Men whose necks are 17 inches or greater, and women whose necks are 16 inches or greater, are at risk.

Sleep apnea patients never get enough good sleep — they don’t get enough oxygen to do that. It puts a huge strain on the heart, the lungs and the brain. They tend to be more susceptible to high blood pressure, heart attacks, stroke, heart arrhythmia and diabetes.

Also, they’re tired and just don’t feel good. There’s also an incidence of patients with sleep apnea having more depression and also more chronic pain.

Q. What are some signs that you might have sleep apnea? Does snoring mean you have it?

A. There are different symptoms. Some of them are being tired, loud snoring, gasping for air and long pauses of breathing at night and morning headaches.

Not everyone who snores has sleep apnea, but a large majority of people with sleep apnea do snore.

The only way you can diagnose it is with a sleep study. The patient comes to our sleep lab at night and we monitor their heart rate and oxygen level.

Q. What are the best treatments for sleep apnea?

A. The best treatment is CPAP — continuous positive airway pressure. After patients are diagnosed, we do ask them to come one more night to fit them with a (CPAP) mask.

The mask doesn’t cure sleep apnea, but it does treat it. It’s like a pill you take for high blood pressure — you start with a low dose, then find out what you need.

Some people cannot tolerate a mask, and there are surgical options. There is also a dental appliance, similar to a retainer, that advances the jaw forward to help open the airways, but it’s not as effective as CPAP.

Some patients find their sleep apnea improves after they lose weight, or get treatment for their low thyroid.

Q. Do children have sleep apnea?

A. Children with big tonsils can have sleep apnea, and in those patients we take their tonsils out and the sleep apnea goes away. Sleep apnea in children has been associated with attention deficit disorder, behavior problems and irritability. When your child is sleep deprived, he’s not going to do well in school and is probably going to have behavioral problems.

Q. How big a problem is insomnia? Will taking sleep aids, either prescription or over-the-counter sedatives, help long-term?

A. Insomnia is becoming more common in our society, particularly in women. The one thing you have to realize is that all these medicines suppress your breathing. If you have sleep apnea, you do not want to take them because they can make your breathing more shallow. Unfortunately, the drugs we have are just short-term treatment options.

The best treatment option is to find out why you don’t sleep.

Q. What are some common causes of insomnia?

A. Some of it is definitely associated with depression and anxiety. And for that we do cognitive behavioral therapy, talking with a psychologist about different ways to improve your sleep. Some of the things that can help is not taking naps, not taking in a lot of caffeine, exercising daily, going to sleep at the same time every night and waking up at the same time every morning. (For more tips, see pages 10-11.)

One thing to realize about sleep is that a lot of it is habit.

Q. You mentioned exercise. How can that help alleviate insomnia?

A. No. 1, it keeps your weight down, but it also releases seratonin, a chemical involved in sleep. Exercise also helps you feel more fatigued toward the end of the day.

Q. Is it O.K. to take sleep aids temporarily, for instance during a stressful time when you’re finding it hard to sleep?

A. Absolutely. They are effective temporarily. But you can become dependent on them. When you stop taking them, you can have what’s called rebound insomnia, but that tends to go away after a few days of being off the medicine. Keep in mind that these medicines can interfere with other medicines. Also, especially in the elderly, they can have side effects such as feeling dizzy or sleepy during the day.

Q. Are there other common sleep disorders?

A. Restless leg syndrome, a creepy, crawly, weird sensation in the legs at night that interferes with patients going to sleep, so it can cause insomnia. They also kick their legs more during sleep, which means they don’t get enough good sleep. It is more common in diabetics, stroke patients or people with Parkinson’s disease or other neurological disorders, but it’s also seen in pregnant patients, and patients with low iron — anemia.

To treat restless leg syndrome, we see if the patient has diabetes or a neurological disorder; also screening for iron levels is important, especially in women and pregnant patients. (If iron levels are low) they can take vitamins with iron supplementation.

If all that is normal, there are medications for it, such as Requip and Mirapex, and also pain medicines and sedating drugs such as valium to help patients who have more severe symptoms.

Q. Do people tend to disregard the importance of sleep?

A. Yes. When you don’t have good, restorative sleep, you feel depressed and can’t function well. Even healthy patients need to improve their sleep. Sleep is so important in your overall well-being. There have been studies that show that if you are sleep-deprived, your immune system is affected. You have to have sleep to live.

Here are some comments by a doctor concerning some of the reports about people doing unusual things while taking sleeping pills.

ANGELA KEEN: Have you received any reports from patients who do unusual things on Ambien or any of the other sleep aids that’s out there now that they’re so popular?

DR. AARON KAUHANE: No, most of the time when people are taking the sleep medication, they’ve reported early on if they’re having any side effects.

ANGELA KEEN: How do these medication work?

DR. AARON KAUHANE: Well what they do is, they tell the brain, a part of the brain to go to sleep and what happens, as the medication takes effect, the body just turns itself off.

ANGELA KEEN: And sometimes the brain is ready to go to sleep but the body’s still kind of working.

(laughing)

DR. AARON KAUHANE: That’s right, every individual is affected differently. It’s like telling all my patients to let me know as soon as you start to feel something that’s not right.

ANGELA KEEN: One thing that’s been talked about is, that you shouldn’t be taking it alone, you shouldn’t be doing activities and take it. What’s your advice for folks out there who really need to get to sleep early or who might be dealing with travel issues and need to get to bed early or on another time zone. What is your suggestion on that?

DR. AARON KAUHANE: Well, I suggest giving a trial period. You definitely don’t want to try it the night before you go on a trip. Having someone, either a spouse, significant other or friend to be there with you so they can look out for any possible side effects that may occur, especially in light of the recent news.

ANGELA KEEN: And take it at your bed side, not anywhere else in the house.

DR. AARON KAUHANE: Oh absolutely, you don’t want to be working out or doing the grocery shopping after taking the medication.

ANGELA KEEN: Or even in the kitchen or wherever. My husband said you’ll going to take it, have it next to the bed stand and that way, you’re not up and around the house.

DR. AARON KAUHANE: That’s right.

ANGELA KEEN: And we should report any adverse reaction to our physician

DR. AARON KAUHANE: Anything, I think the point to make is really having an open line of communication with your doctor, making sure that you can talk to him or her about anything and things should be better.

Two weeks after the Food and Drug Administration issued safety warnings about widely used sleeping pills, the drug maker Merck canceled a venture into the shifting market for insomnia medications.

Merck and its Danish partner, H. Lundbeck, announced that a safe and effective sleeping pill had eluded their scientists after years of study, and they canceled their joint product, gaboxadol. Unusual side effects — including hallucinations and disorientation — showed up in the studies. The drug also failed a trial of its efficacy.

During a conference call yesterday, Lundbeck’s senior vice president for drug development, Anders Gersel Pedersen, said, “We did not want to bring a product to the market with such a shallow risk-benefit ratio.”

Merck, based in Whitehouse Station, N.J., had listed gaboxadol as one of three drug applications it planned to file this year, and called the termination “clearly disappointing.” As recently as two years ago, some Merck scientists had viewed the product as a potential blockbuster, possibly safer and as effective as sleeping medications currently on the market.

Yet analysts did not consider the cancellation a critical setback for Merck. They had forecast the drug’s peak sales at $250 million to $500 million, a sum that would have been shared with H. Lundbeck. Merck’s shares declined 42 cents, or almost 1 percent, yesterday.

Gaboxadol was one of a dozen compounds being tested in what has been a lucrative market for sleep aids. Sales of Ambien and Lunesta exceeded $3 billion in this country last year, and nearly 60 million prescriptions for insomnia medications were dispensed.

But the dollar value of that market is expected to shrink with the release of a generic version of Ambien as early as next month. An analyst with Sanford C. Bernstein & Company, Ronny Gal, summed up Merck’s decision this way: “You’ve got a drug that is questionable in a toughening regulatory environment going into a market that is a lot smaller than people originally thought.”

Gaboxadol’s cancellation appears to highlight company thinking about the limited potential for drugs similar to Ambien and Lunesta as well as the difficulty in bringing sleeping medications to the market in the face of safety questions and hesitancy by the F.D.A.

Last year, Pfizer pulled out of a partnership with Neurocrine on another sleep drug, Indiplon, after regulatory questions by the F.D.A. The agency turned down one version of the drug and delayed action on another. Neurocrine has said it will continue with that project.

Particular concern is focused on those insomnia medications that act on GABA, a brain neurotransmitter that inhibits the nervous system. Both Indiplon and Merck’s gaboxadol acted on GABA.

“The F.D.A.’s caution level with respect to safety and abuse potential is clearly very high, and I think it stems in large part from these GABA-acting drugs,” said David Amsellem, an analyst with Friedman, Billings & Ramsey. The GABA drugs include newer products like Ambien and Lunesta as well as some older benzodiazepene sleep medications, like Halcion.

The most recent F.D.A. statement warned patients that unusual behaviors including sleep-driving and sleep-eating could occur with the drugs. The F.D.A. warning included 13 widely used sleep medications.

Despite negative publicity about the drugs, Mr. Amsellem sees continued demand.

“Ultimately, I think there is a big appetite for insomnia drugs,” he said. “In a perfect drug, you would have effective insomnia drugs with lower abuse potential and lower safety risk. I think we’re getting closer and closer.”

Nearly a dozen other compounds are under development.

Sanofi-Aventis, which makes Ambien and its long-acting formula, Ambien CR, has another sleeping pill in late-stage development, eplivanserin. The drug works on serotonin, a neurotransmitter that plays a central role in mood. Vanda is developing VEC-162 for chronic insomnia that works on melatonin, a hormone that is regarded as the body’s master clock.

The president of Merck Research Laboratories, Dr. Peter S. Kim, said the company remained committed to its sleep disorders research. The company has a sleep drug in Phase 1 development. It has not disclosed how the experimental drug, MK-0454, works.

Mr. Gal of Sanford C. Bernstein said the release of generic Ambien meant that blockbuster status for any new sleep drug would be difficult, unless a completely new compound was developed.

“Unless there is a vast improvement in the efficacy, which will probably only come from a new class of compounds, it’s hard to see a new blockbuster drug emerging,” Mr. Gal said.

U.S. adults average just 6.9 hours of sleep a night, according to the National Sleep Foundation’s 2005 Sleep in America Poll. The group recommends seven to nine hours.

“There are many demands on our time today, and sleep is one of those things that just isn’t the highest priority,” says Michael Twery, director of the National Center on Sleep Disorders Research.

Up to 70 million Americans cope with sleep disorders or chronic sleep loss, according to a guide about healthy sleep from the National Institutes of Health.

That big problem for millions of consumers has “become a gold rush,” for marketers, says Howard Courtemanche, CEO of Health@JWT, a unit of ad agency JWT that specializes in health care marketing.

Companies now hawk everything from prescription sleep medication to relaxing room sprays:

• Mood music. Sleep Garden sells zMusic, a 60-minute CD of music it calls “the sound way to sleep.” Rhino Entertainment and Smash Arts have a CD of classical music titled Bedtime Beats: The Secret to Sleep.

•Body care products and room scents. In February 2006, Unilever’s Dove unit launched the Dove Night line, which includes body wash and lotion. Dove bills the products as a way to “destress the mind and body to ease women into a more restful night’s sleep.”

• Beverages. Last week, Dreamerz Foods announced the national launch of three “dessert drinks” — Chocolate S’Nores (milk chocolate), Vanilla Van Winkle (French vanilla) and Crème de la REM (dark chocolate mint) — that have the active ingredients melatonin and lactium to “help with sleep and relaxation,” says company CEO Amanda Steele.

• Pharmaceutical sleep aids. In 2006, consumers spent $3.6 billion on prescription sleep medications, up 29% from 2005, according to health care and pharmaceutical consulting company IMS Health. It reports that more than 48 million sleep-aid prescriptions were written last year.

Adds Ross: “It’s a communications challenge. It’s not easy to say precisely what you want to say, and a large percentage of your commercial will be filled with the kinds of things that don’t make for very likable conversation, like the possible side effects of the drug.”

We’ve run several stories from the newswires over the years on people doing strange things while talking sleep medicines. Basically, these are bizarre, and very rare sleep aid side effects.

I guess it’s right that the FDA should require label warning about these things… although we shouldn’t lose sight of the fact that some people just do strange things period. Anyway here’s an article that reminds us of these rare incidents, and looks at ways to help those few people might be prone to emptying the refrigerator while asleep.

The Food and Drug Administration is offering new warnings if you take prescription sleeping pills. Those warnings are now required to be printed right on the bottle’s label.

Perhaps you’re among the millions of people taking prescription sleep aids like Ambien and Lunesta every night. Each come with warnings about their potentail side effects.

“They’d get a printout and description of actions, side effects warnings,” Pharmacist Gene Miller told us.

But the FDA says the current warnings aren’t enough. An ABC video shows someone going to the freezer and eating a meal, all while sleeping, under the influence of sleep aids.

The FDA is now requesting drug makers add new warnings to 14 sleep prescriptions. Those warnings include cautioning you about eating while sleeping, talking on the phone, and even driving while you asleep.

The FDA acknowledges those side affects are quite rare. So what alternatives are available if you don’t want to turn to prescriptions?

NEWS 25 went to the Deaconess Sleep Center. Specialist Courtney Guerra tells us you can try turning to the light.

“We turn this light on during the day and it gives us that artificial sunlight,” Courtney Guerra from the Deaconess Sleep Center said.

It’s not your everyday lamp, but Guerra says “Bright Light” therapy helps chemically balance your body. That will get you a good night sleep.

“By nine, ten o’clock… you’re out… just like that,” she told us..

Makers of sleeping pills including Sanofi-Aventis SA’s top-selling Ambien and Sepracor Inc.’s Lunesta should warn that the drugs may cause people to drive, eat or have sex while asleep, U.S. regulators said.

All 13 of the medicines cited by the Food and Drug Administration also need to include stronger warnings about the risk of severe allergic reactions, the agency said today in a statement. Drugmakers have agreed to develop the new warnings, according to the FDA.

Americans spent $3 billion last year on prescriptions for Ambien and Lunesta, the two most heavily advertised drugs in the U.S. While sleep aids are well-tolerated in millions of people, regulators and consumer advocates have said that the increasingly popular medicines are more dangerous than consumers realize.

“These are really life-threatening reactions,'’ said Sidney Wolfe, health research director at the Washington-based consumer group Public Citizen, in a telephone interview. Patients ignore the risks because advertising suggests “something is wrong if they don’t sleep eight hours a night.'’

More than a dozen reports of patients having sex, binge eating, driving or making telephone calls while taking sleeping pills have been submitted to the FDA, said Russell Katz, director of the agency’s neurology division. The patients didn’t remember what they did.

All so-called hypnotic drugs can cause these problems even in patients who have been taking them for a while, Katz said. The FDA isn’t aware of any deaths related to the side effects.

`Difficult to Know’

“They’re rare, but because these are drugs that are intended to put people to sleep, it might be difficult to know that they’re having this event,'’ he said in a conference call.

The agency began talking with companies that make the products in December and worked with them to revise their prescribing information.

Regulators asked the companies to send letters to doctors and develop patient guides that describe risks and recommend precautions, such as taking only the appropriate dosage and avoiding alcohol while on the medicines. The agency is also encouraging drugmakers to conduct clinical studies to determine how often the side effects occur.

“We’re making every necessary step to get the information to patients,'’ Katz said.

Shares of Sepracor, based in Marlborough, Massachusetts, fell $1.10, or 2.3 percent, to $47.71, at 1:33 p.m. New York time in Nasdaq Stock Market composite trading. Paris-based Sanofi’s American depositary receipts, each representing half an ordinary share, fell 38 cents to $41.76.