A 2023 Update on Managing Insomnia in Primary Care: Insights From an Expert Consensus Group.

Objective: To evaluate the status of management of insomnia disorder, describe gaps in current recognition and treatment, identify current guidance for optimal management, and develop up-to-date educational recommendations for primary care providers.Participants: Four insomnia experts representing primary care, psychiatry, and clinical research were selected based on clinical expertise, educational qualifications, and research experience. A patient with insomnia was also included.Consensus Process: The Insomnia Working Group met in March 2022 to review data on available therapies (including medications approved since publication of current guidelines) and share current best practices for evidence-based multimodal treatment of insomnia disorder.Conclusions: Insomnia is highly prevalent but underdiagnosed and undertreated. It is increasingly recognized as a distinct disorder, not merely a symptom arising secondary to another medical or psychiatric illness. The subtypes of sleep disturbance-reports of difficulty falling or staying asleep, insufficient sleep duration, early waking-and the presence of next-day impairment and common comorbid conditions require a targeted, individualized approach to therapy. Challenges exist in treating insomnia with commonly used on- and off-label drugs, including low-dose antidepressants, benzodiazepines, and benzodiazepine receptor agonists because of the risk of adverse effects, including impaired next-day functioning. The dual orexin receptor antagonists have a novel mechanistic target and offer an alternative pharmacologic choice. Optimal outcomes for insomnia require a comprehensive approach that includes lifestyle and behavioral strategies to mitigate maladaptive thoughts and behaviors related to sleep and selection of pharmacotherapy based on individual patient complaints and characteristics.

Challenges and opportunities in insomnia disorder.

BACKGROUND: Insomnia disorder is a prevalent, often unrecognized condition that affects millions. This clinical disorder is characterized by difficulty initiating or maintaining sleep over a sustained period. In fact, insomnia disorder affects much more than sleep; it increases the risk of developing serious medical and psychiatric comorbidities and can exacerbate existing conditions. The association between insomnia disorder and serious medical and psychiatric comorbidities are complex and directionality is not yet fully understood. There remain gaps in the treatment landscape for insomnia disorder. METHODS: We performed a narrative review of the published literature to identify challenges, unmet needs, and burden associated with insomnia disorder. RESULTS: In this article, we describe the substantial burden that insomnia disorder poses on patients, the healthcare system, and society in the US. This article explores the factors attributable to this burden including limited provider knowledge, inadequate treatment options, and unknown long-term impacts of off-label treatments. CONCLUSIONS: Several recommendations are proposed to address these challenges and improve patient outcomes through efforts to: (1) establish the societal value of treatment; (2) improve the clinical understanding of insomnia disorder; and (3) prioritize development of and access to effective treatments that do not pose addiction potential or tolerability issues.

Management of gout in the real world: current practice versus guideline recommendations.

OBJECTIVES: Gout is a chronic, extremely painful disease that is potentially curable when treated effectively. Unfortunately approximately one-half of patients with gout are inadequately controlled. METHODS: We surveyed 315 primary care physicians in the United States and Europe to investigate current practice in the real world, as distinct from recommendations in guidelines. RESULTS: Our survey on 1657 patients found that regular testing of serum uric acid, in conformity with the guidelines, was conducted by approximately 50% of physicians. Advice to patients on diet and lifestyle was less well implemented, and identification of overweight/obese patients was inconsistent. CONCLUSION: Improvements in practice by physicians would include comprehensive assessment of the patient, adoption of regular monitoring during treatment, and the provision of patient education on adherence and lifestyle.

Hot Topics in Primary Care: Update on the Recognition and Management of Gout: More Than the Great Toe.

Gout is a chronic inflammatory condition that is increasing in prevalence and commonly associated with other chronic diseases such as obesity, diabetes mellitus, hypertension, hypercholesterolemia, chronic kidney disease, cardiovascular disease, and thromboembolic disorders. These associations make the management of patients with gout more complex. Although identification of MSU crystals in synovial fluid is diagnostic, a presumptive diagnosis of gout can be made clinically based on the presence of hyperuricemia, rapid development of pain, tenderness, and swelling in a single toe (male) or elbow or finger joint (female), and family history. Gout is increasingly recognized as a heterogeneous disease requiring individualized treatment. A healthy lifestyle is always recommended and patient education is critical to support self-management and long-term adherence. Antiinflammatory therapy, typically colchicine or an NSAID, is recommended for management of an acute gout flare, while ULT may be used in patients with frequent or severe acute gout, tophi, urolithiasis, renal function impairment, or other complications of gout. Allopurinol is first-line ULT for most patients, although febuxostat and probenecid are effective options and pegloticase is useful in selected patients. New medications, such as lesinurad, are on the horizon.

Integrating modern concepts of insomnia and its contemporary treatment into primary care.

Insomnia affects one-third of the adult population. Ten percent of adults surveyed in America consider it a serious problem. Chronic insomnia is associated with poor quality of life and the potential for various psychiatric and medical conditions, notably depression and cardiovascular disease. Since most patients with insomnia are unlikely to disclose obvious sleeping difficulties, the first step in diagnosing and managing patients is having a high index of suspicion in patients with specific complaints, comorbidities, and risk factors. This is followed by a complete evaluation of the patient's medical and physical history to determine if the insomnia is primary or comorbid with another disease. The management of insomnia should consider the extent of impairment associated with the disorder, as well as duration, causes, and comorbidities. In some cases, referral to a specialist is warranted. Recently, there have been new definitions of insomnia proposed; elucidation of the role of orexin-mediated hyperarousal brain neural pathway in the sleep-wake cycle; and new drugs available that target this system. Thus, a review and update for today's primary care physician is warranted.

CaseBook challenges: Managing gout, hyperuricemia and comorbidities -- dialogue with the experts.

The prevalence of gout and hyperuricemia are on the rise in the United States corresponding with an increase in risk factors for these conditions, such as obesity, metabolic syndrome, and the use of diuretics. A progressive disorder, untreated gout can be debilitating and result in tophi, chronic arthropathy, and recurrent kidney stones. Although joint aspiration is needed for a definitive diagnosis, the majority of patients are diagnosed presumptively based on medical history and presentation with characteristic signs and symptoms. Patients with gout also often have multiple comorbidities, and there is an increasing body of evidence that shows hyperuricemia is associated with incidence hypertension, diabetes, chronic kidney disease, and heart failure. Clinical strategies for the management of gout and hyperuricemia must include considerations for these and other common cardiometabolic and renal conditions. In addition to acute flare therapy and prophylaxis, the treatment of gout involves lowering serum uric acid (SUA) levels with the urate-lowering therapies (ULTs) allopurinol or febuxostat. Once begun, treatment with ULT is lifelong. However, inadequate dosing and patient nonadherence or intolerance to therapy often lead to treatment failure. Recent guidelines from the American College of Rheumatology stress tailoring therapy and target SUA level (traditionally <6 mg/dL, but lower levels may be needed for certain patients) based on gout severity and the presence of comorbid conditions. Because painful acute gout flares may result in trips to the emergency department and because the majority of gout cases are managed in primary care, it is important for clinicians practicing in these settings to be able to diagnose and treat this condition and communicate with patients to improve their understanding of the disease process and adherence to treatment.

Casebook consults: improving outcomes in gout (multimedia activity).

Gout is a chronic, potentially debilitating condition characterized by an inflammatory process in the joints or periarticular tissues that results from the deposition of monosodium urate crystals. Underdiagnosis and undertreatment can lead to the development of tophi and chronic arthropathy. A presumptive diagnosis of gout can be made on the basis of the clinical presentation as well as risk factors such as metabolic syndrome. Key conditions to rule out in the differential diagnosis are septic arthritis, calcium pyrophosphate deposition disease (pseudogout), fracture, and rheumatoid arthritis. Acute flares of gout should be managed with nonsteroidal antiinflammatory drugs (NSAIDs), colchicine, or corticosteroids. With a diagnosis of gout, if urate-lowering therapy (ULT) is required, prophylaxis should be considered with low-dose colchicine or an NSAID, followed by the addition of ULT. The goal of ULT is to reach a serum uric acid (SUA) level ≤6.0 mg/dL. Measurements of SUA should be obtained after resolution of an acute attack, then periodically to facilitate titration of the ULT dose to achieve the target SUA level. Studies have confirmed significant reductions in gout attacks among patients who have attained SUA levels ≤6.0 mg/dL with ULT. Patient education concerning the disease and its treatment is essential to ensure close adherence with recommended therapies. Patients should also understand that ULT is intended as long-term, and for most patients, lifelong therapy to maximize the prospects for control of the disease. Clinicians should feel confident in making a presumptive diagnosis and choosing a therapeutic regimen for gout while effectively communicating with and educating patients about their disease.

Hyperuricemia and gout: new concepts in diagnosis and management.

Gout is a chronic, progressive condition for which hyperuricemia is the primary risk factor. The initial episodes of gout may be brief, only lasting for 3 to 5 days, and patients may experience pain-free intercritical periods that last from months to years. However, as the disease progresses, acute gout flares become more frequent and prolonged (typically lasting ≥ 5-10 days). Chronic gouty arthritis develops, with shorter pain-free intervals; tophi become visible and interarticular joint damage occurs. Patients with advanced gout experience chronic pain and a decreased quality of life. Gout prevalence has increased significantly over time. Despite the increase in the number of gout cases, the disease is often mismanaged, especially in primary care. Hyperuricemia is inadequately controlled as a result of suboptimal dosing with urate-lowering drugs, intolerance to therapy, or poor patient compliance. This review article provides a comprehensive discussion of gout pathophysiology, risk factors, and approaches to treatment that encourage the clinician to appreciate hyperuricemia as a multifaceted disorder and manage the condition optimally.

2011 Recommendations for the diagnosis and management of gout and hyperuricemia.

Gout is a major health problem in the United States; it affects 8.3 million people, which is approximately 4% of the adult population. Gout is most often diagnosed and managed in primary care physician practices. Primary care physicians have a significant opportunity to diagnose and manage patients with gout and improve patient outcomes. Following publication of the 2006 European League Against Rheumatism (EULAR) gout guidelines, significant evidence on gout has accumulated and new treatments for patients with gout have become available. It is the objective of these 2011 recommendations for the diagnosis and management of gout and hyperuricemia to update the 2006 EULAR guidelines, paying special attention to the needs of primary care physicians, who manage most patients with gout. The revised 2011 recommendations are based on the Grading of Recommendations Assessment, Development, and Evaluation approach as an evidence-based strategy for rating quality of evidence and grading strength of recommendation in clinical practice. A total of 26 key recommendations for diagnosis (n = 10) and management (n = 16) were evaluated. Presence of tophus (proven or suspected) and response to colchicine had the highest clinical diagnostic value (likelihood ratio [LR], 15.56 [95% CI, 2.11-114.71] and LR, 4.33 [95% CI, 1.16-16.16], respectively). The key aspect of effective management of an acute gout attack is initiation of treatment within hours of onset of first symptoms. Low-dose colchicine is better tolerated than and is as effective as high-dose colchicine (number needed to treat [NNT], 5 [95% CI, 3-13] and NNT, 6 [95% CI, 3-72], respectively). For urate-lowering therapy, allopurinol in combination with probenecid was shown to be more effective than either agent alone (effect size [ES], 5.51 for combination; ES, 4.46 for probenecid; and ES, 2.80 for allopurinol). Febuxostat, also a xanthine oxidase inhibitor, has a slightly different mechanism of action and can be prescribed at unchanged doses for patients with mild-to-moderate renal or hepatic impairment. Febuxostat 40 mg versus 80 mg (NNT, 6 [95% CI, 4-11]) and 120 mg (NNT, 6 [95% CI, 3-26]) both demonstrated long-term efficacy. The target of urate-lowering therapy should be a serum uric acid level of ≤ 6 mg/dL. For patients with refractory and tophaceous gout, intravenous pegloticase is a new treatment option.

Is shift work making your patient sick? Emerging theories and therapies for treating shift work disorder.

"Shift work" is a term that applies to a wide array of nontraditional work schedules. Shift work disorder (SWD) is a circadian rhythm sleep disorder experienced by a subset of shift workers that is characterized by excessive sleepiness during work and/or insomnia during scheduled sleep times. It is estimated to affect up to 2 million Americans, and is associated with increased morbidity and mortality from metabolic risk factors, cardiovascular and gastrointestinal diseases, depression, accidents, and some kinds of cancers. Patient history is all that is needed to make a diagnosis with the International Classification of Sleep Disorders-Second Edition criteria as described herein. Circadian rhythm disorders, in which an underlying misalignment of circadian rhythm with the sleep-wake cycle occurs, may be treated by behavioral and pharmacologic approaches, including the use of hypnotics to improve the duration of sleep. However, evidence is limited with these approaches in patients diagnosed with SWD. Other treatment options may include pharmacologic interventions such as modafinil and armodafinil, which have shown efficacy in this population. Combined therapy can reduce insomnia and excessive sleepiness, and improve attention and alertness during work shifts and the subsequent commute home.

Managing your patient with gout: a review of treatment options.

Gout is an inflammatory arthritis that typically presents as acute onset, recurrent, monoarticular pain. In most patients, management of pain, risk assessment for future flares, and disability is not optimal and diagnostic and management approaches are applied inconsistently. Obtaining an accurate patient history, including comorbidities, concomitant medications, and familial history, is important for optimal results. Recognizing the acute flare in the patient at risk and establishing a definitive diagnosis of gout should be conducted promptly. Therapeutic options appropriate for treating the acute flare include colchicine, nonsteroidal anti-inflammatory drugs, and corticosteroids. After flare remission, prophylaxis with a flare prevention medication, such as colchicine, should be administered followed by initiation of urate-lowering therapy with allopurinol or febuxostat. Patient education, especially counseling on risk factors and contributors to hyperuricemia and gout, can improve the likelihood of successful therapy for this often suboptimally managed disease.

2011 recommendations for the diagnosis and management of gout and hyperuricemia.

Gout is a major health problem in the United States; it affects 8.3 million people, which is approximately 4% of the adult population. Gout is most often diagnosed and managed in primary care practices; thus, primary care physicians have a significant opportunity to improve patient outcomes. Following publication of the 2006 European League Against Rheumatism (EULAR) gout guidelines, significant new evidence has accumulated, and new treatments for patients with gout have become available. It is the objective of these 2011 recommendations to update the 2006 EULAR guidelines, paying special attention to the needs of primary care physicians. The revised 2011 recommendations are based on the Grading of Recommendations Assessment, Development, and Evaluation approach as an evidence-based strategy for rating quality of evidence and grading the strength of recommendation formulated for use in clinical practice. A total of 26 key recommendations, 10 for diagnosis and 16 for management, of patients with gout were evaluated, resulting in important updates for patient care. The presence of monosodium urate crystals and/or tophus and response to colchicine have the highest clinical diagnostic value. The key aspect of effective management of an acute gout attack is initiation of treatment within hours of symptom onset. Low-dose colchicine is better tolerated and is as effective as a high dose. When urate-lowering therapy (ULT) is indicated, the xanthine oxidase inhibitors allopurinol and febuxostat are the options of choice. Febuxostat can be prescribed at unchanged doses for patients with mild-to-moderate renal or hepatic impairment. The target of ULT should be a serum uric acid level that is ≤ 6 mg/dL. For patients with refractory and tophaceous gout, intravenous pegloticase is a new treatment option. This article is a summary of the 2011 clinical guidelines published in Postgraduate Medicine. This article provides a streamlined, accessible overview intended for quick review by primary care physicians, with the full guidelines being a resource for those seeking additional background information and expanded discussion.

Managing gout in the primary care setting: what you and your patients need to know.

The US prevalence of gout, a rapidly progressive inflammatory arthritic condition linked to serum uric acid levels, has grown in recent years, in part due to the increasing prevalence and incidence of predisposing factors in the population, such as metabolic syndrome, obesity, and the use of diuretics. Left untreated, gout can be debilitating and cause deformity. Although a definitive diagnosis requires joint aspiration, only approximately 11% of patients with suspected gout undergo this procedure, and a presumptive diagnosis based on patient medical history and presentation with characteristic symptoms and comorbidities is a reasonable guidelines-based approach that has utility in the primary care setting, where approximately 70% of all cases and nearly 3,000,000 visits occur. The therapeutic standard for patients with recurrent gout flares is urate-lowering therapy (ULT), including allopurinol and the recently introduced febuxostat, the first new treatment for gout in 40 years. Although ULT must be taken consistently to sustain benefits, inadequate dosing and patient nonadherence or intolerance to therapy often lead to treatment failure. It is important that primary care clinicians understand gout diagnosis and therapeutic approaches and can communicate effectively with patients to improve treatment adherence. ONLINE ACCESS: http://cmeaccess.com/cme/ajm_gout_program/ This CME Multimedia Activity is also available through the Website of The American Journal of Medicine (www.amjmed.com). Click on the CME Multimedia Activity button in the navigation bar for full access.

Optimal treatment of obstructive sleep apnea and excessive sleepiness.

INTRODUCTION: Collapsibility of the upper airway in obstructive sleep apnea (OSA) causes repeated arousals from sleep, decreased oxygen saturation of the blood, and excessive sleepiness (ES). Patients with OSA are at increased risk of cardiovascular and cerebrovascular disease, and experience occupational and vehicular accidents more frequently than the general population. Furthermore, the life expectancy of patients with untreated OSA is significantly reduced. METHODS: A MEDLINE search of articles published between 2003 and 2008 was conducted using the search terms: obstructive sleep apnea [ti/ab] AND treatment; obstructive sleep apnoea [ti/ab] AND treatment; and excessive sleepiness [ti/ab] AND treatment. Searches were limited to articles in English; clinical trials; meta-analyses; practice guidelines; randomized, controlled trials; and reviews. RESULTS: Continuous positive airway pressure (CPAP) is the reference-standard treatment for patients with OSA. CPAP addresses the symptoms of OSA and reduces the risk of heart disease and depression associated with this sleep disorder. However, the efficacy of CPAP is contingent on patient adherence, and >or=4 hours of therapy per night are required for patients with OSA to experience significant clinical benefits. However, reports of nonadherence to CPAP therapy range from 29% to 83%. Other therapies are available for patients who refuse or cannot adhere to CPAP treatment, including dental devices and surgery, but these treatments are generally considered to be less efficacious. A significant number of patients continue to experience residual ES despite CPAP treatment. Pharmacologic therapies, eg, modafinil and armodafinil, may be of use in patients with OSA to improve tolerance with CPAP or to address residual ES. CONCLUSION: There are a variety of treatments available for patients with OSA. Successful treatment involves encouraging patient compliance with CPAP or oral appliances. Primary-care physicians play a crucial role in recognizing this disorder and ensuring the best possible outcome through support and education.

Screening & treating patients with sleep/wake disorders.

Sleep/wake disorders are common, underdiagnosed, and associated with serious consequences. Patients tend not to mention sleep problems and clinicians often do not ask about them. Using a few simple screening questions and tools can uncover sleep/wake disorders that will respond to treatment. Consider asking about sleep during annual physicals and regular visits for chronic conditions. This is especially relevant when following patients with conditions linked to sleep/wake disorders. Educating patients about normal sleep and good sleep hygiene may improve sleep and prompt mention of unhealthy sleep/wake patterns.The use of CPAP leads to beneficial outcomes in OSA. Psychological and behavioral measures offer the best choice for patients with chronic insomnia. Bright light can help retrain the circadian rhythm in patients with circadian rhythm sleep disorders. Dopamine agonists are approved for treatment of RLS. Through a greater awareness of sleep/wake disorders and taking a proactive approach to patient questioning, diagnosis, education, and management, clinicians can better detect and treat sleep/wake disorders and improve patient outcomes and quality of life.

Recognition of obstructive sleep apnea and associated excessive sleepiness in primary care.

By being aware of the symptoms, predisposing factors, and comorbidities associated with obstructive sleep apnea (OSA), primary care providers can play a vital role in screening their patients for OSA. The most common symptom of OSA is excessive sleepiness. Medical providers can assess degree of sleepiness very effectively and easily by administering the Epworth Sleepiness Scale (ESS). Currently, polysomnography is required to confirm a diagnosis of OSA. Follow-up in the primary care setting is essential to ensure appropriate continued therapy. ESS is the preferred method to assess degree of residual sleepiness after treatment initiation.

Insomnia: zolpidem extended-release for the treatment of sleep induction and sleep maintenance symptoms.

Insomnia impairs daytime functioning or causes clinically significant daytime distress. The consequences of insomnia, if left untreated, may contribute to the risks of developing additional serious conditions, such as psychiatric illness, cardiovascular disease, or metabolic issues. Furthermore, some comorbidities associated with insomnia may be bidirectional in their causality because psychiatric and other medical problems can increase the risk for insomnia. Regardless of the serious consequences of inadequately treated insomnia, clinicians often do not inquire into their patients' sleep habits, and patients, in turn, are not forthcoming with details of their sleep difficulties. The continuing education of physicians and patients with regard to insomnia and currently available therapies for the treatment of insomnia is, therefore, essential. Insomnia may present as either a difficulty falling asleep, difficulty maintaining sleep, or waking too early without being able to return to sleep. Furthermore, these symptoms often change over time in an unpredictable manner. Therefore, when considering a sleep medication, one with efficacy for the treatment of multiple insomnia symptoms is recommended. A modified-release formulation of zolpidem, zolpidem extended-release, has been approved for the treatment of insomnia characterized by both difficulty in falling asleep and maintaining sleep. Here, we review studies supporting the use of zolpidem extended-release in the treatment of sleep-onset and sleep maintenance difficulties.

Stay awake! Understanding, diagnosing, and successfully managing narcolepsy.

Sleep is a physiologic state that performs an essential restorative function and facilitates learning and memory consolidation. When sleep is disrupted for more than a short time, normal daily functions decline. Mood, attention, and behavior deteriorate. Sleepiness and disrupted sleep can result from a large number of pathological disorders. Currently, 88 sleep disorders are listed in the International Classification of Sleep Disorders, as established by the American Academy of Sleep Medicine, and sleep disorders adversely affect more than an estimated 70 million Americans. Most of these disorders can be classified as causing insomnia and/or hypersomnia. Insomnia results from disorders that cause difficulty with falling asleep and staying asleep; examples are hyperarousal, circadian dysrhythmia, and homeostatic dysregulation. In contrast, hypersomnia refers to difficulty in staying awake and is characterized by recurrent episodes of excessive daytime sleepiness or prolonged nighttime sleep. Hypersomnia can result from several primary sleep disorders, including narcolepsy, sleep apnea, restless legs syndrome, idiopathic hypersomnia, and periodic limb movement disorder. The effects of some of these sleep disorders and other chronic illnesses on daytime sleepiness are measured using the Epworth Sleepiness Scale. Narcolepsy was found to cause some of the highest measures of excessive sleepiness. This supplement uses a case-based approach to describe the underlying pathology and symptoms of narcolepsy. Differential diagnosis of narcolepsy and current treatment options will be discussed.

Recognizing sleep disorders in a primary care setting.

As many as one third of the general population suffers from some form of sleep disorder. Although sleep disorders are widespread in society, few patients present with overt sleep complaints; they instead present with symptoms of fatigue, excessive sleepiness, and impaired waking function. Untreated sleep disorders, particularly insomnia, can lead to potentially life-threatening automobile crashes and industrial accidents. In addition, poor motor, mental, and cognitive function at home, work, and school can negatively impact a patient's quality of life. Therefore, physicians must maintain a high index of suspicion for sleep disorders whenever they see patients, and they must ask sleep-related questions during office visits for acute conditions, chronic conditions, and annual physical examinations. Today's "24/7" society experiences sleep disorders in ever-increasing numbers, and people who work shifts are at risk for developing circadian rhythm sleep disorder, particularly shift work sleep disorder. Physicians must engage their patients in a discussion of their occupations and sleeping habits in order to detect and treat sleep disorders.