Optimizing the Pharmacologic Treatment of Insomnia (original) (raw)
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Journal of Clinical Sleep Medicine
Introduction: The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations: The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources. 1. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 2. We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 3. We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 4. We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 5. We suggest that clinicians use triazolam as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 6. We suggest that clinicians use temazepam as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 7. We suggest that clinicians use ramelteon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 8. We suggest that clinicians use doxepin as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 9. We suggest that clinicians not use trazodone as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 10. We suggest that clinicians not use tiagabine as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 11. We suggest that clinicians not use diphenhydramine as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 12. We suggest that clinicians not use melatonin as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 13. We suggest that clinicians not use tryptophan as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 14. We suggest that clinicians not use valerian as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK)
Journal of central nervous system disease, 2018
Insomnia remains a common clinical concern that is associated with negative daytime consequences for patients and represents a significant public health problem for our society. Although a variety of therapies may be employed to treat insomnia, the use of medications has been a dominant approach. Regulatory agencies have now classified insomnia medications into 4 distinct pharmacodynamics classes. Medications with indications approved for insomnia treatment include benzodiazepine receptor agonists, a melatonin receptor agonist, a selective histamine receptor antagonist, and a dual orexin/hypocretin receptor antagonist. Both pharmacodynamic and pharmacokinetic advances with hypnotic medications in recent years have expanded the pharmacopoeia to allow personalized treatment approaches for different patient populations and individual sleep disturbance patterns.
Insomnia: Pharmacologic Therapy
2017
Insomnia accounts for more than 5.5 million visits to family physicians each year. Although behavioral interventions are the mainstay of treatment, pharmacologic therapy may be necessary for some patients. Understanding the risks and benefits of insomnia medications is critical. Controlled-release melatonin and doxepin are recommended as first-line agents in older adults; the so-called z-drugs (zolpidem, eszopiclone, and zaleplon) should be reserved for use if the first-line agents are ineffective. For the general population with difficulty falling asleep, controlled-release melatonin and the z-drugs can be considered. For those who have difficulty staying asleep, low-dose doxepin and the z-drugs should be considered. Benzodiazepines are not recommended because of their high abuse potential and the availability of better alternatives. Although the orexin receptor antagonist suvorexant appears to be relatively effective, it is no more effective than the z-drugs and much more expensiv...
Current Patterns and Future Directions in the Treatment of Insomnia
Annals of Clinical Psychiatry, 2005
Background. Despite the high prevalence and the high burden associated with chronic insomnia, it remains largely unrecognized and often inadequately treated by physicians. Methods. A review was undertaken of the literature on barriers to both acute and chronic treatment of insomnia, as well as recent trials of pharmacologic and nonpharmacologic agents for insomnia. Results. Obstacles to appropriate treatment of the condition include outdated insomnia management guidelines, which have contributed to US Food and Drug Administration restrictions on longer-term prescription of hypnotic agents; lack of research demonstrating the benefit of treating insomnia; and fears of tolerance and withdrawal effects of long-term use of hypnotic agents, as well as an absence of longer-term, randomized, controlled, double-blind trials of existing agents used to treat insomnia. Conclusions. There is evidence that improved sleep may improve outcome in some medical and psychiatric illnesses. Both behavioral and pharmacologic therapies have shown efficacy in chronic insomnia. In addition, a recent 6-month, randomized, controlled study has demonstrated that at least one agent may be safe and effective in longer-term use.
Special Considerations for Treatment of Insomnia
Several of the preceding chapters have already raised important issues that require consideration when treating patients with insomnia. The aim of this chapter is to address a number of additional special considerations including side effects, gender, age, comorbidity, reasons insomnia may be treatment resistant (e.g., presence of unhelpful beliefs or worry, daytime distress), and legal issues.
Modern standards for pharmacological treatment of insomnia
Pediatria i Medycyna Rodzinna, 2019
In clinical practice, insomnia can be classified as temporary and chronic. They differ in duration. Chronic insomnia lasts over 3 months, with symptoms occurring at least 3 times a week. Insomnia treatment standards were defined e.g. by the American Academy of Sleep Medicine in 2017. There are two treatment approaches. First, non-pharmacological methods should be applied, which are the basis of treatment and guarantee its sustained effect. These methods include abiding hygiene of sleep rules, sleep period limits, stimuli control and cognitive therapy. The second form of treatment is pharmacotherapy. It is based on benzodiazepine receptor agonists, which have replaced previous benzodiazepines. They have less side effects and lower addictive potential. This group includes zolpidem, zaleplon and zopiclone. Dosing regimen mainly depends on the form of insomnia being treated: temporary or chronic. Accidental and temporary insomnia should be treated with hypnotics without delay. It is advised to have a pill near one's bed and take it only when the patient waits too long to fall asleep after laying down or after an arousal. Such dosing scheme significantly reduces the risk of addiction and lowers the risk of transformation of insomnia into the chronic form. In chronic insomnia, when benzodiazepines are taken daily, 2 week period cannot be exceeded. Prolonged time is only allowed when using the drugs 2-3 times a week (or up to 10 times a month). Such pharmacotherapy guidelines are easier to tolerate, when the patient simultaneously complies with behavioural therapy. Besides that, a tricyclic antidepressant drug can also be used-doxepin. The list of inadvisable medications for the treatment of insomnia is composed of: trazodone, tiagabine, diphenhydramine, melatonin, tryptophan, valerian.
New directions in the pharmacologic treatment of insomnia
CNS spectrums, 2008
This article reviews the recently Food and Drug Administrationapproved sleep-promoting medications as well as new compounds being investigated as possible future insomnia treatments. The new medications indicated for the treatment of insomnia include significant advances in pharmacokinetic and pharmacodynamic approaches. All approved sleep-promoting medications are indicated for difficulties with sleep onset and some have an additional indication for sleep maintenance. The recently approved insomnia medications no longer have an implied restriction on their duration of use. There is now a controlled-release formulation of a benzodiazepine receptor agonist, as well as a selective melatonin receptor agonist. New potential pharmacologic targets for treating insomnia have become evident, with advances in the understanding of the neural mechanisms regulating the sleep-wake cycle. Currently being evaluated are a wide range of compounds that modulate γ-aminobutyric acid, histamine, serotonin, melatonin, adenosine, corticotrophin-releasing factor, and hypocretin/orexin systems. Needs Assessment: Three new medications recently have been approved Needs Assessment: Three new medications recently have been approved Needs Assessment: This activity has been peer-reviewed and approved by Eric Hollander, MD, chair at Mount Sinai School of Medicine. Review
Sleep Medicine Reviews, 2009
For many years practitioners have had limited data from double-blind, placebo-controlled studies to guide the types of decision-making needed to optimally manage patients with insomnia in clinical practice. However, in recent years there has been a great increase in insomnia research studies that address issues of clinical importance. This body of work represents an increasingly useful empirical basis for making clinical practice decisions. The purpose of this article is to compile the body of work on the pharmacological management of insomnia to make it available in as accessible form as possible for optimal application in clinical practice with the hopes that doing so will decrease the gap separating the available research and the clinical management of insomnia and, thereby, improve the care of the many individuals who suffer from this condition. The review of studies consists of the following sections: 1) basic pharmacology; 2) double-blind, placebo-controlled trials in adults with primary insomnia; 3) double-blind, placebo-controlled trials in elderly patients with primary insomnia; 4) adverse effects reported in placebo-controlled trials in elderly primary insomnia patients; 5) double-blind, placebocontrolled trials in adults and the elderly as a function of treatment duration; 6) double-blind, placebocontrolled trials of the treatment of comorbid insomnia. Issues related to the application of these data to clinical practice are discussed in the text.
Neurotherapeutics, 2012
The benzodiazepine receptor agonists (BzRAs) a melatonin receptor agonist and a histamine antagonist have all been approved as hypnotics. Beyond their differing mechanisms of action, they have differences in pharmacokinetics, and among the BzRAs differences in receptor subtype affinity and formulations, which provides the physician with broad options for tailoring therapy to each patient's specific needs. Consistent with their specific pharmacokinetics and formulations, these Food and Drug Administration-approved hypnotics have been shown to improve sleep with no evidence of tolerance development in long-term use. In addition, emerging data indicate these drugs also improve aspects of daytime function. Their side effects are either associated with the direct sedating effects of the drugs, doses greater than clinical doses, or a combination with alcohol or other sedating drugs. Anxiolytic BzRAs, sedating antidepressants and antipsychotics have been used off-label as hypnotics. However, in the absence of information regarding their dose range for efficacy and safety, their use as hypnotics is ill-advised.