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28.04.2015

Drugs for sleep maintenance, labyrinthitis vertigo cure - .

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Needs Assessment: Three new medications recently have been approved by the Food and Drug Administration for the treatment of insomnia, and several others are currently being investigated. CME Accreditation Statement: The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide Continuing Medical Education for physicians. The Mount Sinai School of Medicine designates this educational activity for a maximum of 3 AMA PRA Category 1 Credit(s)TM.
To receive credit for this activity: Read this article and the two CME-designated accompanying articles, reflect on the information presented, and then complete the CME quiz.
This article reviews the recently Food and Drug Administration-approved sleep-promoting medications as well as new compounds being investigated as possible future insomnia treatments. Difficulty initiating sleep and maintaining sleep are very common problems in the general population.
A comprehensive elucidation of processes regulating sleep and wakefulness identify appropriate targets for pharmacologic interventions that would guide the development of pharmaceuticals to correct any perturbations associated with an individual’s insomnia. Most current insomnia pharmacotherapeutic strategies, whether or not they are Food and Drug Administration-approved for the treatment of insomnia, have sedating mechanisms of action.
The recommendation of a medication for the treatment of insomnia will depend largely on efficacy and safety factors. Medications or other substances that people may use with the intention of treating insomnia include prescription medications with an FDA approval for the treatment of insomnia, prescription medications FDA approved for indications not including the treatment of insomnia, regulated over-the-counter (OTC) medications, and unregulated substances (eg, dietary supplements).1 Only the medications approved by the FDA for the treatment of insomnia have been evaluated for safety and efficacy for this use. Patients with comorbid conditions, especially mood and anxiety disorders, may be prescribed assorted medications with sedating properties with the intention of improving sleep. The question of how long a sleep-promoting medication can be used has led to some confusion. The United States Drug Enforcement Agency (DEA) classifies medications according to their abuse potential and whether they have a legitimate medical use.
One other administrative factor that influences the use of particular medications is whether they are on formularies or have significant copays associated with their use.
Herbal remedies, homeopathic preparations, melatonin, and assorted dietary supplements have been marketed as sleep aids.
Several antihistamines (H1 receptor antagonists) are marketed as OTC sleep aids alone or in combination with analgesics, particularly acetaminophen.
Even when no psychiatric comorbidity is present, sedating antidepressants are commonly prescribed and sedating antipsychotics are occasionally prescribed with the sole intention of improving sleep onset or maintenance. There is minimal efficacy and almost no safety data for the use of these medications in the treatment of chronic insomnia. The medications currently approved for the treatment of insomnia include five traditional benzodiazepine hypnotics, four nonbenzodiazepine hypnotic formulations, and a selective melatonin receptor agonist.
Ramelteon is the only FDA-approved medication indicated for the treatment of insomnia that does not act through the GABAA receptor complex and does not promote sedation.10 Rather, it is a selective agonist for the MT1 and MT2 melatonin receptor subtypes present in the suprachiasmatic nucleus.
Ramelteon is available in a single 8-mg dosage, which is recommended for adults, older adults, patients with mild-to-moderate chronic obstructive pulmonary disease and sleep apnea, and for those with mild hepatic impairment. While clinical trials have demonstrated improvement during the first few nights that ramelteon is taken, patients may not experience the maximum sleep-enhancing effects for 2–3 weeks. A wide range of pharmacokinetic and pharmacodynamic approaches has been explored in the attempt to develop new sleep-promoting medications. The most recent innovation with benzodiazepine receptor agonist hypnotics has been the modified-release formulation that extends the duration of nighttime sedation, but allows a rapid reduction of the serum concentration to minimize the risk of next-morning sedation or impairment.
Several compounds which enhance GABA-ergic neurotransmission through mechanisms not affecting the benzodiazepine recognition site also have been investigated as possible sleep-promoting agents. Another pharmacologic target being investigated for the treatment of insomnia is the postsynaptic 5-HT2A receptor.
The histamine system also remains a target for the development of sleep-promoting medications.
Doxepin is an older tricyclic antidepressant with sedating properties that has been prescribed to enhance sleep.
Although individuals suffering with insomnia may try a wide assortment of remedies, only the medications approved by the FDA as sleep-promoting agents have demonstrated efficacy and safety in the treatment of insomnia. In recent years, there have been significant advances in the treatment of insomnia with new pharmacokinetic and pharmacodynamic approaches, and new research has highlighted novel targets for pharmacologic interventions. The new medications indicated for the treatment of insomnia include significant advances in pharmacokinetic and pharmacodynamic approaches.


Although considerable progress has been made in the delineation of key neural processes influencing sleep and waking, the task is far from complete. The promotion of sedation to enhance sleep is a general approach that may be beneficial to a broad range of patients. The two key efficacy options relate to the ability of a medication to improve sleep onset and sleep maintenance, which may have separate FDA indications. These medications that are not approved for the treatment of insomnia often are prescribed on an off-label basis for insomnia patients without comorbid conditions. Until 2005, the FDA indication for all of the approved insomnia-treatment medications was for short-term use. The cost of a prescription to a patient sometimes will determine the selection of a sleep-promoting agent. More problematic is the potential for anticholinergic side effects, such as blurred vision, dry mouth, constipation, urinary retention, and delirium.1 These effects are more likely to occur in elderly individuals and patients simultaneously taking other medications also with anticholinergic effects. Since certain psychiatric medications have sedating properties, they may offer some benefit in enhancing sleep. Walsh5 reviewed 2002 data on prescribing practices and showed that most of the medications commonly prescribed for the treatment of insomnia are not approved for that indication.
The panel report from the National Institutes of Health (NIH) State-of-the-Science chronic insomnia conference specifically did not endorse the use of sedating antidepressants for the treatment of insomnia due to the adverse-effect profile and the very limited evidence for efficacy.1 The sedating antidepressants prescribed on an off-label basis for the treatment of insomnia include trazodone, mirtazapine, amitriptyline, and doxepin. Although some patients may experience improvement in sleep onset and maintenance, they also may have residual sleepiness the following morning after bedtime use due to the moderately long elimination half-life.
Key characteristics of the benzodiazepines and nonbenzodiazepine hypnotics are listed in the Table.7 All are relatively rapidly absorbed and have indications for sleep onset, and some are additionally indicated for sleep maintenance. It is recommended that a full night (7–8 hours) be available for sleep following a bedtime dose. Some strategies have built upon existing mechanism of action but have been designed to optimize the timing of medication exposure and reduce potential adverse effects, while others have been based on entirely new pharmacologic targets highlighted by advancing knowledge regarding the neural mechanisms regulating sleep and wakefulness. Among the pharmacodynamic actions of trazodone is blockade at this receptor; however, trazodone interacts with several other receptors which increase the safety concerns in using it as a sleep-promoting medication. Although doxepin has been available for many decades at strengths ranging from 10–150 mg, clinical trials currently are being performed with 1 mg, 3 mg, and 6 mg doses to evaluate its efficacy in the treatment of insomnia. Continued advances in understanding the neural regulation of the sleep and wakefulness should allow the development of insomnia treatment approaches that can be recommended for specific patient populations. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. All approved sleep-promoting medications are indicated for difficulties with sleep onset and some have an additional indication for sleep maintenance. Approximately 10% of adults experience chronic insomnia, which lasts at least 1 month but often persists for months or years. Most current insomnia treatments represent variations on earlier themes where sedating properties were recognized long before there were pharmacodynamic explanations for the effects. Medications may be selected for durations of action to target particular insomnia patterns.
Sedating substances, such as fermented beverages and other plant preparations, have been available for thousands of years. All of the FDA-approved sleep-promoting medications may be beneficial for insomnia associated with sleep-onset difficulty. Key issues with sleep-promoting medications include the potential for undesired next-day sedation following bedtime use and cumulative central nervous system (CNS) depression from concomitant use of multiple sedating medications. From a pharmacokinetic perspective, the approved sleep-promoting medications have relatively low risks of interaction, as these medications are not inducers or inhibitors of hepatic metabolic pathways.
Several other compounds with unique mechanisms of action are being investigated for possible insomnia treatment indications.
Sedating antidepressants dominate this category; however, antipsychotics and mood stabilizers are also sometime prescribed to promote sleep.
At the present time, all of the newer-generation insomnia treatment medications are available only in branded formulations.
The use of a single sedating medication for a primary psychiatric indication that additionally enhances sleep is appealing, as this strategy may be cost effective and promote medication adherence. Three of the top four insomnia-related prescriptions were for antidepressants and only four of the top 16 were for medications with an FDA indication for the treatment of insomnia.


Although none are formally indicated for middle-of-the-night use, a very short half-life hypnotic (eg, zaleplon) could be taken later during the night as long as at least 4 hours remain available for sleep.
It may also improve sleep over time through stabilization of the circadian regulation of the sleep-wake cycle.
The potential for drug-drug interactions is very low, and the only medication that it should not be combined with is fluvoxamine. Drugs used to treat insomnia in 2002: regulatory-based rather than evidence-based medicine.
Only recently has it been possible to develop insomnia treatments based upon emerging knowledge regarding the processes regulating the sleepiness and wakefulness. Except for those with short half-lives, hypnotics additionally may improve sleep maintenance. In general clinical populations, the abuse liability of sleep-promoting medications is low. The short-term indication evolved during an era when barbiturates and benzodiazepines were the predominant medications prescribed for insomnia.
However, there also may be advantages in using separate medications for sleep promotion and psychiatric symptoms. Zolpidem ER maintains the medication serum concentration longer during the night, but declines later during the sleep period. On sudden discontinuation from a hypnotic, patients may experience rebound insomnia for 1–2 nights.
Efficacy studies have shown consistent benefits in the improvement of sleep onset with limited effects on sleep maintenance. For these reasons it is the only approved sleep-promoting medication that is not classed as a Schedule IV controlled substance by the US DEA. Like gaboxadol, tiagabine is of interest because it increases slow-wave activity during sleep. There is now a controlled-release formulation of a benzodiazepine receptor agonist, as well as a selective melatonin receptor agonist.
Chloral hydrate and laudanum (opium and alcohol mixture) were first used for treating insomnia in the mid-1800s.
It is important to keep in mind that the risk-benefit ratio in using a medication for an FDA-indicated condition (eg, bipolar disorder or schizophrenia) may be very different for individuals without that condition.
One potential problem with employing a sedating antidepressant or antipsychotic at bedtime is residual daytime sleepiness. Accordingly, ramelteon is most likely to be helpful for individuals with difficulty falling asleep and remaining asleep during the early part of the night. Additionally, alternate delivery approaches that bypass gastrointestinal absorption have been studied for benzodiazepine receptor agonist hypnotics with the goal of a more rapid onset of action. New potential pharmacologic targets for treating insomnia have become evident, with advances in the understanding of the neural mechanisms regulating the sleep-wake cycle. Clinical trials have included intranasal and sublingual formulations of short-acting hypnotics, such as zolpidem and triazolam.
Further studies will be necessary to clarify both safety and efficacy if it is to be recommended to promote sleep.
The benzodiazepines first were used for sleep in the 1960s and 1970s, and the more selective non-benzodiazepine analogues became available in the 1980s and 1990s.
The majority of hypnotic medications are most appropriately taken at bedtime, which should reduce the wake time later during the night and allow sufficient time for the serum levels to decline to reduce the risk for next-day residual effects. The earlier compounds had the advantage of efficacy in promoting sleep, but had significant safety problems associated with them.
However, very short-acting sedating hypnotics have the added benefit of flexibility in the timing of the dosing, so middle-of-the-night use and strategic daytime doses may safely promote sleep for relatively short periods.
While the widespread CNS distribution of GABAA receptors presumably is an important feature influencing the safety and efficacy of these hypnotic medications, GABA neurotransmission with the presence of GABAA receptors in the ventrolateral preoptic nucleus likely has a critical role in the sleep-promoting effect. Accordingly, they may be used for as long as is medically appropriate and a greater number of doses can be prescribed at one time.



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