The first clinical trial for Xyrem, titled Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients was conducted by Orphan Medical. The study began in December 2000 with approximately 200 people enrolled. The purpose was to test the safety and efficacy of Xyrem when given to patients who are diagnosed with narcolepsy. The patients who were using any medication for cataplexy had to stop taking it during this trial. Patients were prescribed a dose oral solution of either Xyrem or a placebo during a 10 to 11 week period. Symptoms of narcolepsy will be recorded and evaluated. Patients had permission to continually use the medications at constant doses during the trial. Each patient had to visit the sleep center for 1 to 3 daytime visits plus 4 overnight visits to complete the trial. This trial was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. An NDA (New Drug Application) was sent to the FDA during the same year of this clinical trial. It was given a priority review, where the FDA will accelerate the review process for a drug compared to standard review times.
In 2005, Orphan Medical was bought by Jazz Pharmaceuticals. However, before and after the buy out various clinical trials were being conducted to test for Xyrem’s efficacy in treating narcoleptic symptoms like cataplexy and excessive daytime sleepiness (EDS). Two clinical trials looked at cataplexy in narcolepsy while two other
Narcolepsy is a sleeping disorder that occurs during the adolescence stage. It is peculiar as it causes the afflicted person to develop a spontaneous sleep cycle during the day. This disorder prompts “sleep attacks” to occur, and can even be accompanied by cataplexy, random muscle failure or really just REM sleep paralysis (Zimbardo, Johnson, Weber,2008, p.109). It can be dangerous as the attacks can be triggered at any time by intense feelings of emotion or a lack of stimulation. This means that in cases such as driving, sexual intercourse, and times of extreme happiness a narcoleptic person could just fall straight into REM sleep (Zimbardo, Johnson, Weber,2008,
The purpose of this paper is to go into extensive research on Alprazolam aka “Xanax” in the duration of this paper, it will be evident the impact that this drug can have on the human body and in my instances, it will be apparent not only how helpful it can be but how life damaging it can be, if not taken safely and carefully. This report will go into extensive detail on the psychodynamics of the drug as well as the pharmacokinetics. Alprazolam is quite powerful and mind altering the affects that it can have on the body can be very intense, especially if not taking carefully which is why it is vital to make sure that you take the recommended doses taken by your doctor, failure to do so can result in death.
Tardive dyskinesia is a persistent movement disorder that can result from a prolonged use of antipsychotics and is more prominent with the use of atypical antipsychotics. My preceptor decided to start the patient on Clozapine because of its effectiveness with previous clients that had tardive dyskinesia. According to my preceptor, Clozapine has shown signs of minimizing symptoms of tardive dyskinesia. Treatment did not start immediately as the patient had to get baseline labs, which included absolute neutraphil count, blood glucose, and lipid levels. Patient's weight, height, and BMI were also obtained. AIMS scale was not used with this patient as it does not include tremors. Effectiveness was based on the patients subjective account, and physical observation. Clozapine was started at a low dose and titrated up to 125mg PO QHS. Patient is getting weekly lab work for absolute neutraphil count. To date, there is no sufficient data available that suggests a cure for this movement disorder. However, the question is, among adults, what available treatments have shown the greatest effectiveness in minimizing the symptoms of tardive
In his article “Narcolepsy,” Jerome M. Siegel discusses the disease and its possible causes. To begin with, Siegel defines the symptoms and problems associated with the disease. Moreover, he states what exactly the disease is, his research into its causes and effects on the nervous system, and the possibility that the narcolepsy may be an autoimmune disease.
Narcolepsy is a sleeping disorder that affects 1 in about 2,000 people in the United States. Many people are unaware that they have this disorder, and it goes undiagnosed. Narcolepsy affects your sleeping pattern, including irregular patterns in your Rapid Eye Movement (REM), and significant disruptions in your normal sleep/wake cycle. There is no cure for this disorder, but it is treatable. We also don’t know what causes it.
Theophylline is one example of xanthine that is usually used to treat bronchial asthma through relaxing the airways. However, this drug may cause severe adverse effects because of its level in the blood. Thus, it is important to teach patient about the use of theophylline. Teach a patient that theophylline can help him to breath easier, decrease wheeze and short of breath if taken exactly as prescribed. The nurse should also tell the patient take the drug of an empty stomach with a full 8-ounc glass of water. If patient has a severe GI problem such as GI upset, nausea, vomiting, heartburn when taking the drug on an empty stomach, the patient may take the drug with food. The patient should swallow all the enteric-coated or time-release capsules. Educating the patient about other common effect of the drug includes restlessness, nervousness, and difficulty in sleeping because of the need of the body to adjust to the usage of this drug. The patient should not take any other stimulant in order to reduce the effect of theophylline on CNS. The nurse should tell the patient that a headache will go away as the patient get used to the drug. However, the patient should notify his physician if the headache is getting worse. The patient should also report any vomiting, severe abdominal pain, tachycardia, confusion, unusual tiredness, muscle twitching, rash, or hives to the physician. There are many drug and food interaction, thus the patient should consult with the doctor about his diet while using theophylline. Additionally, the patient should consult his smoking habit and the use of any over-the-counter medication with the physician. Lastly, the patient should always tell any health care provider in his care about the use of theophylline and to keep the medication in a safe place (Karch, 2013, p.
While there is no cure for narcolepsy, there are treatments to make managing symptoms easier. There are three treatments for narcolepsy. According to Mayo Clinic, there are three treatments for narcolepsy. The first being selective serotonin reuptake inhibitors (SSRI) or Serotonin and Norepinephrine reuptake inhibitors (SNRIs). These treatments can subdue the REM sleep, to help with the other symptoms. The second treatment is antidepressants. They are only effective for cataplexy but can have dangerous side effects. The last treatment is Sodium Oxybate (Xyrem). Xyrem is one of the most effective treatments for Narcolepsy. Xyrem improves nighttime sleep, which in turn improves the excessive daytime sleepiness and cataplexy. Currently over 60,000 people are prescribed Xyrem. However, Xyrem can be very detrimental. Xyrem can cause coma or death if mixed with alcohol or other
Prescriptions for sleeping medications reached 56 million in 2008, thats 54%more than in 2004, sleeping pills can be consumed for many reasons, 27% of Americans say reasons for sleeping issues are usually anxieties about personal finances, the economy or a job loss, adults are not the only people taking these medicines, 10-19 year old are the most common to use because of ADD medication, though 40% of adults will have sleeping problems occasionally, the medications can vary very wide that are considered as sleeping pills. Barbiturates are a type of drug that causes sedation by depressing the central nervous system. In larger doses it can be used as a general anesthetic to put people to sleep. Benzodiazepines are usually the most commonly prescribed for sleeping issues, the
A recent study conducted by SAMHSA unit of the United States revealed that there was a steep increase in the number of emergency-room visits owing to the intake of prescribed sleep medications like Ambien. The study analyzed ER archives from 2005-2010, which indicated that the ER visits related to Ambienhad risen by 220 percent over the five years. The study report concluded that careful monitoring of drugs like Ambien is a necessity for safe use by the public. This article further discusses and uncovers the reasons behind the rise in Ambien-related ER visits in America.
The websites chosen to research was Medline Plus, Genetics Home Reference and National Institutes of Health. The topic researched was narcolepsy.
Sleep paralysis is a common condition with a prevalence of 5-62%, although most affected people have single or infrequent episodes (Dahlitz). Occasionally sleep paralysis is found to run in a family, and it can be associated with other disorders of hypersomnia, such as sleep apnea (Becker 81). Narcolepsy has also been linked with sleep paralysis; both are thought to be REM sleep disorders (Siegel). Gender and race do not seem to be a factor of risk for this disorder. The episodes of sleep paralysis seem to range from ages 5-35 (Dahlitz). The use of anxiolytic medicines, psychiatric disorders and high anxiety can also contribute to sleep paralysis (Larkin).
You can feel better and get relieved from narcolepsy but curing it is not really possible. Moreover, the patient has to be aware that the effects of the drug may take some time to ensue. Caffeine is not advisable in patients who are taking Waklert. If you are hypersensitive or allergic to these medicines and the ingredients, refrain from taking it. The progress of the patient should be continuously monitored. The sleeping pattern of the patient should be made regular. When the medicine is given to a patient with a history of psychosis, emotional instability or psychological illness, the baseline behavioral assessments should be frequently made. The patient should be kept under expert vigilance all the time. Armodafinil can lead to changes in mood, perception, thinking and judgment. Such signs and symptoms should be intimated to the doctor. Lastly, be careful about side effects like anxiety, depression, dizziness, fever, headache and
The patient is a 50-year-old female who has been seeing Dr. Lynch to help with her sleep issues. She did not however undergo a sleep study. She has been using melatonin 3 mg at night, which has been helpful to get her to fall asleep. She tells me however that she generally wakes up almost every night between one and two o'clock in the morning and can have some difficulty getting back to sleep. She states that she is a person who requires at least nine hours of a good sleep to feel rested. Dr. Lynch did ask her to try Zaleplon 5 mg to use if she wakes at one or two in the morning. The patient however, read the side effects of this and got too afraid to try it. She has not tried any other prescription medications for sleep hygiene. She does tell me she has difficulty sleeping because her husband has sleep
A 2010 study tested the effectiveness of a new FDA approved atypical antipsychotic medication Lurasidone. The researchers performed four six week clinical trials to test the
The efficacy and safety of the drug in patients under the age of 18 years is not established. With renal / hepatic insufficiency and long-term treatment, control over the picture of peripheral blood and liver enzymes is necessary. Patients who did not take previously psychoactive drugs respond to the drug at lower doses compared to patients taking antidepressants, anxiolytics or alcohol. With endogenous depression, alprazolam can be used in combination with antidepressants. With the use of alprazolam, patients with depression have seen cases of hypomanic and manic development. Like other benzodiazepines, alprazolam has the ability to induce drug dependence in long-term admission in large doses (more than 4 mg / day). With a sudden discontinuation of alprazolam, there may be comeback syndromes, such as depression, irritability, insomnia, increased sweating, especially with prolonged admission (more than 8-12 weeks). When patients develop such unusual reactions as increased aggressiveness, acute excitations, feelings of fear, thoughts of suicide, hallucinations, increased muscle cramps, difficult sleep, superficial sleep, treatment should be discontinued. During pregnancy Xanax is very dangerous due to its toxic effect on the fetus and increases the risk of congenital malformations when applied in the first trimester of pregnancy. Admission of therapeutic doses in later periods