What is Ambien?
Ambien is a prescription drug formula that is used to treat insomnia as well as some brain disorders. The chemical formula is zolpidem which offers an anticonvulsant as well as a muscle relaxant. It is a fast acting (typically fifteen minutes or less), hypnotic which affects the inhibitory neurotransmitters. Half a dose of Ambien will leave your system within two to three hours of being taken.
What is Ambien CR?
Ambien CR is different from Ambien in that it offers two (2) layers – the first which dissolves very quickly and the second which dissolved during the night which is said to help you stay asleep longer than Ambien itself. Both medications have the same active ingredients, though Ambien CR is said to reduce the risk of the morning after ‘hangover’ that is inherent in some sleeping medications.
Ambien CR is said to work on the GABA receptor part of the brain (a benzodiazepine receptor) and acts as a hypnotic agent. It has been shown in multiple studies that Ambien CR administered in a 12.5 mg dose to a healthy male that the peak concentration occurs at about one and a half hours after ingestion and that food intake increases that time to between two and four hours, though the half life does not change. As a result of this study Ambien (or Ambien CR) is not recommended to be taken with food or immediately after a meal.
Controlled Studies for Chronic Insomnia
Two controlled studies were run on patients with chronic insomnia, the first double blind study involved patients between the ages of eighteen and sixty four – none knew if they were taking Ambien CR 12.5 mg or if they were being given a placebo. Ambien CR was proved to be superior to a placebo, by increasing not only sleep induction, but keeping the patient asleep. The second study was conducted on elder patients (ages 65 and over) and had a three week study using Ambien CR 6.25 and a placebo. It was successfully proven that Ambien CR did help decrease the amount of time that a person woke after being asleep for hours varying from six (6) during the first two nights and up to four (4) hours after two full weeks of treatment. Again Ambien CR proved to be move valuable than a placebo not only helping someone fall asleep but also helping them to stay asleep longer without waking up. The other benefit of this study showed that those who were on the Ambien CR were much more rested at the end of the night than those who were given the placebo.
Studies of After Affects
The after affects of Ambien CR were studied in a total of five (5) studies, three (3) in adults between ages 18 and 64, and two (2) in adults over the age of 65. The younger group was given Ambien CR 12.5 and the older group Ambien CR 6.25 – and in both cases, vigilance, memory and motor functions were te4sted. While there was no evidence of decrease after a night time dose (8 hours after dose) nor was their evidence of next day residual affects of any of these, there were incidences of somnolence, 15% in the group receiving 12.5 mgs and about 6% in those receiving 6.25 compared with only 5% in the group who received a placebo. The study also reviewed the effects of dose-dependent rebounds (i.e. latency, sleep efficiency, number of times waking up in the night) and the affects were minimal, occurring only on the first night after a sudden stopping of Ambien CR. However, on the second night, the results for those taking Ambien CR and those not taking it were the same.
Additional Research Studies
A research study was performed on some patients who were in minimally conscious coma states, they were considered prior to the tests to be in permanent coma conditions and the Ambien CR was given to them to help put them to sleep. Instead of this happening, some patients actually were brought to a fully conscious state and were capable of not only communicating, but interacting for the first time in years in some cases. It is believe that the use of the drug actually increases activity in the frontal lobe of the brain in some patients in a minimally conscious state. Larger scale studies have been launched to determine how widespread this effect might be on patients who are currently in a minimally conscious coma state.
Potential for Abuse/Recreational Use
Recreational drug use is unfortunately widespread and because of the affect that Zolpidem creates, recreational drug users may crush Ambien (or Ambien CR) and snort it, cook it and use it intravenously, or simply take the entire pill. Intravenous use of this drug, often in very low doses (5mg), can induce the user into an unconscious state within seconds. Unfortunately, taking zolpidem for longer than the recommended period of time (which is generally less than a month) can often result in those who were using the drug medicinally becoming recreational users. If the drug is taken by someone who has had a dependency on drugs or alcohol in the past and zolpidem in doses higher than the usual 10mg, it is easy for them to become dependent on the drug. Increased and intensified effects of Zolpidem can be caused by mixing with substances such as alcohol.
While Ambien (and Ambien CR) are in fact sleeping pills, those who use the drug recreationally claim that they can force themselves to stay awake and doing so often causes delusions or hallucinations. For those who suffer from various forms of neurosis or those who are in a heightened state of anxiety, they can easily fight the effects of sedation and experience euphoric feelings. In addition, the recreational user may have perceptional changes, visual distortions, auditory distortions, odd behavior, confusion, decreased anxiety, mild euphoria or a loss of balance.
Sanofi-Aventis the manufacturer has opted to attempt to fight this abuse with a flexible plastic-like coating which sticks to the drug often hindering the process of insufflations though many agree that for a seasoned recreational drug user this is not much of a hindrance.
High doses or abuse of zolpidem can cause physical dependence which can be severe and result in epileptic seizures when going through the detoxification process. As with other sedative hypnotic drugs, Ambien and Ambien CR have been found in a high percentage of suspected drugged drivers.
Dependence and withdrawal
Those patients who have been treated for prior drug or alcohol abuse should not be prescribed Ambien or Ambien CR by their physicians. There is sufficient proof that those who have been dependent on other drugs or alcohol show an increased tendency to become dependent on the zolpidem. This abuse may be physical or psychological and because of that should be avoided. Since withdrawal symptoms are often severe, the risk is very high.
Overdose
Overdoses of Ambien or Ambien CR can result in depressed respirations, excessive sleepiness, pin-point pupils and if left untreated my lead to the person being in a coma or even lead to death. When Ambien or Ambien CR is combined with alcohol, opiates, or other central nervous system depressants, there is am even higher likelihood that overdoses become fatal. Overdoses may be treated with Anexate, Lanexat, Mazicon, or Romazicon given intravenously which reverse the effects within one or two minutes.
Ambien and Ambien CR Side Affects
Unfortunately, as with many prescription drugs, side affects may occur when taking Ambien or Ambien CR even if the drugs are taken exactly as prescribed by your physician.
Side affects of Ambien or Ambien CR may be as simple as an increased appetite or more complex such as:
1. Anterograde amnesia
Memory loss which occurs mysteriously which may be short-lived that diminishes the capacity to learn, may result in failure to recollect facts, forget how to talk, etc.;
2. Hallucinations
May be visual, olfactory, gustatory, tactile, proprioceptive, nociceptive, thermoceptive, auditory. It is important to note that hallucinations are not the same as illusions which is a sensation which is attributed to misinterpreting what you see.
3. Dizziness, head pain, drowsiness
Unfortunately these side affects tend to be a little more common in those who use Ambien or Ambien CR. While typically these affects are annoying, talk to your physician about possibly decreasing your dosage or perhaps taking at a different time of the day.
4. Nausea/Throwing up
This can be prevented easily by taking your medications with crackers or avoiding taking it on a completely empty stomach.
Ambien and Ambien CR have both been linked to some even more serious side affects. In March of 2007 the FDA issued a warning for most sleep aids that warned consumers of allergic reactions as well as what were called ‘complex sleep related behaviors’. These ‘behaviors’ include sleep driving, eating in your sleep, sleepwalking, and also included anaphylaxis (life threatening allergic reaction) and angioedema (severe facial swelling). While reportedly these side affects were rare, and in fact no deaths had been reported as a result of any of them, it was determined that all sedative/hypnotic drugs needed to carry the warnings about these side affects.
Some patients reported other side affects, that while were not life threatening – can be quite disconcerting. These included preparing meals, eating meals, talking on the phone, even having sex – and no memory of these events taking place. Because Ambien and Ambien CR are medications that are designed to put you to sleep, it is sometimes difficult to know if these are happening as you’re falling asleep or if they are happening after you’ve been asleep. Sanofi Aventis sold $1.9 billion worth of Ambien and Ambien CR in the first nine months of 2006, according to the company. Sanofi Aventis sold $1.9 billion worth of Ambien and Ambien CR in the first nine months of 2006, according to the company. In a statement, Ambien manufacturer Sanofi Aventis said warnings on sleep behaviors, known as somnambulism, were already included in its drug’s label.
”While complex behaviors associated with somnambulism have been reported, the information currently contained in the U.S. prescribing information remains accurate: Somnambulism is a possible rare adverse event that occurred in our clinical trials at a rate of less than 1 in 1,000 patients,” the company said.
Pros and Cons of Sleeping Pills
Sleeping pills work in various ways. For instance, Diphenhydramine works on histamine receptors in the brain, and helps cause you to feel drowsy. Typically, these medications will help you sleep between four and six hours, your risk of dependence is low, however daytime sleepiness, confusion and sometimes difficulty in urinating can be associated with these drugs.
The class of drugs that are known as ‘sleep/wake cycle modifiers’ (ramelteon) are designed to stimulate melatonin receptors in your brain which helps control your sleep wake cycle. The risk of dependency with this classification of drugs is very low, however side affects may include headaches, drowsiness, dizziness, loss of sex drive, trouble with menstrual cycles and inability to get pregnant. This classification of drugs will typically help you sleep between four and six hours.
The drugs classified as benzodiazephies are designed to bind to the GABA receptors in your brain. Risk of addiction is high in this classification of drugs and the amount of sleep they provide varies widely from four to more than twelve hours. The side affects associated with these drugs range from sedation to a loss of muscle coordination, dizziness and habitual use of the drug.
- Some male patients have also reported prolonged and painful erections as a result of taking these medicines.
Medications like Ambien CR (zolpidem tartrate extended release) are designed to work on specific GABA receptors in your brain, can help you sleep between six and eight hours, have a low to medium risk of dependence (typically very low) and side effects may include memory disturbances, hallucinations and change in overall behavior.
There have been many stories told about some of the side affects of Ambien and Ambien CR – to protect privacy we’ve removed people’s names but here are some of them:
I thought that I was writing the loveliest poetry one night (well, it turned out to be complete nonsense and was barely legible) I had written 3 pages of complete garbage that had something to do with a scarecrow. It was pretty bad!
I piled every knick-knack in my apartment in one corner of my bedroom (I thought it was a great idea at the time, until I discovered the pile the next day and had to clean it up)
I dumped out all of my drawers in one pile because I had been meaning to clean them out. Well, I ended up not having time to clean up the mess for several weeks (it took three hours to sort out the piles) and so whenever I needed something from the pile, I had to dig through it to find whatever I was looking for! Once again, this seemed like a really good idea when I was on Ambien!
I once called a colleague I had just met at three in the morning to tell him that I was wearing pajamas. I didn’t remember doing it until the next day when he asked me, “So, um, what was up with the phone call last night??” Luckily, he had a sense of humor about it.
I took 1 10mg Ambien. I decided to sit down at the computer and check my e-mail for a few minutes until I felt drowsy, then go to bed and read my book until I was ready for sleep. My next conscious thought was waking up on the sofa at 7:30am. Several music CD’s wren out that I apparently was listening to, I had poured a glass of grape juice, made and ate a sandwich, smoked a couple of cigarettes because there were butts in the ashtray that I remembered emptying, and the television was on. I have absolutely NO RECOLLECTION of any of these activities!
From a medical director of the Minnesota Regional Sleep Disorders Center in Minneapolis, “We’ve had people eat very inappropriate things that they would never eat while awake. Some example would be buttered cigarettes, salt sandwiches, raw bacon.”
My wife had a very bad reaction to Ambien awhile back. It was basically an all-night panic attack. She couldn’t hold still, was crying constantly, was freaked out by everything around her, rolling around on the floor throughout the house.
The hospital gave my mom this to help her sleep when she had Guillain-Barre syndrome. She would call people in the middle of the night from the hospital and have no recollection of it when people asked her why she called.
From the Washington Post: The most prescribed sleep medication in the United States may be linked to episodes of sleepwalking and related strange and dangerous behaviors, experts say — including incidents of nocturnal eating, phone conversations, shoplifting and even driving — of which the subject has no memory.
Sleep specialists and researchers cite a growing though still inconclusive body of reports associating Sanofi-Aventis’s drug Ambien with the incidents. More than 24 million prescriptions for Ambien were written in 2004.
Timothy Morgenthaler, a researcher at the Mayo Clinic Sleep Disorders Center in Rochester, Minn., says he has seen many cases of people who sleepwalk and sleep-eat after taking Ambien.
He described five such cases in a 2002 report in the journal Sleep Medicine. All those patients stopped having sleep-eating episodes when they discontinued Ambien, Morgenthaler said. Since then he has seen many similar cases, he said.
“I feel pretty comfortable that this is a real phenomenon,” he said.
Sanofi-Aventis, the French maker of the drug, declined to make officials available for interviews. The company issued a statement saying the side effect is known but rare, and that “when taken as prescribed, Ambien is a safe and effective treatment for insomnia.” The side effect is disclosed in the product’s full labeling material, where it is cited among numerous central nervous system side effects.
Other case reports of Ambien-related sleepwalking have been published in medical journals, and researchers of the Minnesota Regional Sleep Disorders Center reported 19 additional cases at a medical conference last year.
Reports made to the Food and Drug Administration (FDA) by doctors and patients show more sleepwalking incidents associated with Ambien than with all other sleep aids combined.
None of these observations proves Ambien causes sleepwalking, and questions about the side effect were not raised during the FDA’s preapproval review of the scientific data. The agency approved the drug in 1993.
Ambien and other newer sleep drugs are considered safer than previous types, in that they are believed to be less addictive and less toxic even in overdose.
If you spend a nightmarish amount of time trying to fall asleep, you’re certainly not alone. If it continues, do seek assistance from your physician; however be aware of all of the side affects that are associated with any drugs that help you fall asleep.
From the Washington Post:
The case of lifelong insomnia sufferer Janet Makinen is typical of the Ambien incidents.
The 55-year-old resident of Dade City, Fla., said she took Ambien nightly for six years. During that time, she regularly got out of bed after having fallen asleep, went to the kitchen and ate, she said.
”I went from wearing a size 1 to wearing a size 12,” Makinen said. “I would eat raw eggs. I would eat a half-gallon of ice cream. I would eat a bag of potato chips, a loaf of bread.”
She would find evidence of her night eating afterward, she said, but had no memory of doing it.
Makinen, identified via an Internet message board where people share Ambien stories, was interviewed late last year. She has since become a plaintiff in a class-action lawsuit against Sanofi-Aventis filed in federal court on March 6.
Others involved in the lawsuit face criminal charges for things they have done while they say they were sleepwalking on Ambien, including driving and shoplifting. One alleges she was twice sexually assaulted after taking Ambien, and has only partial memories of the incidents.
Susan Chana Lask, a New York lawyer who represents the plaintiffs, says that besides seeking damages, they hope to force the drug company to provide stronger cautions about sleepwalking. “People need to know about the risks of serious problems associated with this drug,” she said.
Sanofi Aventis declined to comment on the suit, which a spokesman said the company had not seen.
Dozens of Ambien users have reported being involved in auto accidents they do not remember, according to news reports and interviews.
Some sleep experts interviewed said the side effect is increasingly familiar to academic and research sleep specialists. But many mainstream sleep clinicians see no problems with the drug, interviews showed. No expert interviewed said he or she had stopped prescribing Ambien due to fear of side effects.
Helene Emsellem, medical director of the Center for Sleep and Wake Disorders in Chevy Chase, says she has seen no link between Ambien and sleepwalking in her practice, which is one of the largest of its type in the region. “Nor do we see [Ambien] standing out as problematic” among other available sleep medications, she said.
Partial Arousal
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Somnambulism, the clinical term for sleepwalking, is a “partial arousal” disorder, in which a person is not fully asleep but not completely awake.
In addition to medications, sleepwalking can be triggered by sleep deprivation, alcohol, fevers, stress, and some mental and neurological conditions.
Ambien may render some people unable to awaken completely even when something significant disturbs their sleep, so they enter the state of partial arousal, some experts say. “It is the case, perhaps, of an unstoppable force meeting an immovable object,” said Michael Sateia, chief of the Section of Sleep Medicine at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and past president of the American Academy of Sleep Medicine.
According to Stacia Sailer, medical director of the Sleep Disorders Center at the University of Massachusetts, Amherst, some people taking sleep medications (not just Ambien) can, in that partial state of arousal, carry out many routine activities. The case of Lt. Judith Renee Lasswell, 39, a Navy intelligence officer stationed in Tampa, included several bizarre incidents, including a case of alleged shoplifting that threatens her military career.
According to the complaint in the class-action suit, she once wandered into the intelligence center where she works talking incoherently, and her colleagues led her back to bed. She said she has no memories of the episode.
But most damaging was an incident last September when, after taking Ambien, Lasswell said she sleepwalked into the base exchange, carrying several DVDs which she had purchased previously or rented from the base library. After returning an “X-Files” DVD to receive store credit, she was approached by base police, who claimed she had taken the DVD off the shelf, failed to pay for it and returned it for credit. She was handcuffed and charged with shoplifting DVDs and a candle.
Lasswell said she has no memory of the incidents.
According to the complaint, Lasswell’s top-secret security clearance was subsequently revoked, and she faces larceny charges and a dishonorable discharge. A 17-year Navy veteran, she risks losing her pension and severance pay.
”I’ve never had a problem before in my life until I took Ambien, and it’s literally ruined my career and everything I ever worked for,” Lasswell said in a statement. “I have gaps in memory from the whole time I was on Ambien, which is very terrifying.”
In January, Lasswell requested a polygraph test to support her defense in the military judicial process. According to the test report, a copy of which was provided by Lask, Lasswell denied intending to steal and falsely claiming store credit, and said she did not remember the events related to the incident. The polygraph examiner found “no deception” in her responses, according to the report.
Difficult Data
There is no reliable estimate of how many Ambien users sleepwalk, and no one knows who might be at risk. The prescribing information for Ambien lists somnambulism as a “rare” side effect, meaning that it has been reported in fewer than one in 1,000 patients.
Sateia says a lack of solid data on post-approval side effects makes it impossible to know whether the company’s estimation of the rate is accurate.
After a drug is approved and marketed in the United States, the FDA accepts (but does not actively solicit) reports of side effects from doctors, patients and drug makers. FDA adverse event report databases contain sleepwalking reports from 1997 through June 2005. (Ambien has been available in the United States since 1993, but sleepwalking events per se were not reported before 1997.)
There are 207 sleepwalking reports. Most of the incidents are considered “idiopathic” by physicians reporting the episodes, meaning their cause is not known. Of all sleep aids, however, Ambien is linked to the most incidents — 48 of them, or about a quarter of the total.
The data contain two reports associated with Sonata, a drug that acts in a way similar to Ambien. Sonata was approved in 1999. The data contain no sleepwalking reports for Lunesta, the newest sleep drug, which was not widely available until April 2005.
There are also fewer reports linked to older sleep aids called benzodiazepines, including Ativan, Halcion, Restoril, Valium, and Xanax. For these six drugs, which when considered as a group were prescribed more times than Ambien, there are 18 reports collectively.
Larry Sasich, a pharmacist and consultant to Public Citizen, a consumer advocacy group, says the adverse event reports “raise a legitimate question” about a possible association between Ambien and sleepwalking, particularly since “what winds up in the FDA’s database is only the tip of the iceberg.” Researchers believe that only a small portion of adverse drug reactions are reported to the FDA.
Adverse event data must be interpreted carefully because many things affect what is reported and how often. Sleepwalking is particularly tricky to track. It’s not like liver failure, for example, which unmistakably either happens or does not. Many people may never find out about their sleepwalking or may not understand what they experienced. Others are reluctant to report it: “People do not volunteer this information,” Morgenthaler said. “If you do not ask specifically about this behavior, you will miss most of it.”
The Mayo Clinic Sleep Center’s standard patient questionnaire now includes questions about sleep-related eating.
”In a sane world . . . [reports like those for Ambien] would be an occasion for FDA to ask the manufacturers to do careful surveillance,” said Jerry Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, a Harvard Medical School affiliate. “But they’re not going to do that.”
Meanwhile, Sanofi has introduced a new formulation of Ambien, called Ambien CR, designed to sustain sleep throughout the night. Sonata and Lunesta are spending hundreds of millions of dollars on advertising to battle for market share, and competing drugs are working their way toward approval. Consumers are being sold on the benefits and safety of sleep medications as never before.
”That can give patients, and physicians for that matter, the impression that the management of [sleep] problems is as simple as giving someone a prescription for a sleeping medication and sending them on their way,” Sateia said. “It’s not that simple.”
no more overdosing but we shall hug , talk , and get through this hard tough experience called life!
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