scholarly journals Safety and Efficacy of Armodafinil in the Treatment of Excessive Sleepiness

2011 ◽  
Vol 3 ◽  
pp. CMT.S5124
Author(s):  
Jamie N. Brown ◽  
Dustin T. Wilson
Keyword(s):  
Adverse Effects ◽  
Health Care Providers ◽  
English Language ◽  
Rating Scales ◽  
Data Extraction ◽  
Current Evidence ◽  
Care Providers ◽  
Sleep Study ◽  
Excessive Sleepiness ◽  
Obstructive Sleep

Objective To review the efficacy and safety of armodafinil for the treatment in patients with excessive sleepiness. Data sources Literature was accessed via MEDLINE (1966–February 2011) and EMBASE (1980–February 2011) using the medical subject heading terms armodafinil and sleep. Study selection and data extraction All English-language, peer-reviewed publications were analyzed for relevance. Studies appropriate to the objective were evaluated if they prospectively assessed the effectiveness of armodafinil in patients with excessive sleepiness in a multiple-dose, comparator trial. The literature search identified published reports of 7 randomized, placebo-controlled studies. Data synthesis Armodafinil is a wakefulness-promoting agent used in the treatment of patients with excessive sleepiness and is the R-enantiomer of modafinil. Studies have demonstrated that armodafinil may be effective and safe when used in patients with obstructive sleep apnea, circadian rhythm disorders, and narcolepsy. Although the studies identified had limited sample sizes, they consistently demonstrated improvement on various efficacy rating scales for sleep. Study durations ranged from 3 days to 12 weeks, with doses ranging from 50 mg to 250 mg daily. The most common adverse effects associated with armodafinil therapy were headache, nausea, diarrhea, dizziness, and anxiety, although increases in systolic blood pressure and pulse rate were also reported. Conclusion Current evidence suggests that armodafinil significantly improves wakefulness in patients with excessive sleepiness in studies up to 12 weeks. Long-term effectiveness and safety cannot be adequately determined at this time. Although armodafinil should be considered safe for use, health-care providers should monitor for adverse effects, particularly cardiovascular complications.

scholarly journals Sleep Disorders During Pregnancy and Postpartum: A Systematic Review

2021 ◽  
Vol 12 (2) ◽  
pp. 81-93
Author(s):  
Zahra Behboodi Moghadam ◽  
Elham Rezaei ◽  
Azam Rahmani
Keyword(s):  
Sleep Disorders ◽  
Sleep Disorder ◽  
Health Care Providers ◽  
English Language ◽  
Care Providers ◽  
Related Factors ◽  
Sleep Related Breathing Disorders ◽  
Obstructive Sleep ◽  
Pregnancy And Postpartum ◽  
Health Related

This study aimed to asses previous research results about bio-physiological alterations during pregnancy and postpartum, and make clear outlook about prevalence and related factors of sleep disorders during pregnancy and postpartum. In this review, the articles that published from 2000 to 2019 were reviewed. Related articles were searched from databases in English language. After evaluation of inclusion and exclusion criteria, articles were chosen and reviewed based on the University of York strategies. Sleep disorders in present study were classified according to the International Classification of Sleep Disorders-3. The search revealed 4449 articles, after evaluating and assessing qualified articles, finally 56 article selected to review. According to the results of this review, The prevalence of sleep disorders was almost 76%–97% in whole pregnancy. The most common sleep disorders included central disorders of hyper somnolence (waking up in the middle of the night, daytime sleepiness, sleeplessness) or insomnia, sleep-related movement disorders (restless legs syndrome), sleep related breathing disorders (obstructive sleep apnea), and parasomnia. In addition, sleep disorder may continue 3–12 months postpartum (33.2%). Sleep disorders induced by physiological processes (fetal movement, excessive weight gain, male sex of the fetus, and multiparty), health-related risks (metabolism disorders, cardiovascular diseases, and mood disorders), and physical or sexual abuse in childhood. In addition, these disorders could have maternal outcomes that can be greatest trigger to postpartum psychiatric disorders and fetal outcomes that have harmful sequences during childhood (sexual, fertility, emotional, and cognitive problems). Health care providers should evaluate the mothers’ sleep quality because sleep disorder leads to harmful consequences in fetuses and children.

Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea

2020 ◽  
Vol 54 (10) ◽  
pp. 1016-1020 ◽  
Author(s):  
Jason Powell ◽  
Chris Piszczatoski ◽  
Scott Garland
Keyword(s):  
Clinical Trials ◽  
Obstructive Sleep Apnea ◽  
Clinical Practice ◽  
Sleep Apnea ◽  
English Language ◽  
Data Extraction ◽  
Clinical Trial Data ◽  
Excessive Sleepiness ◽  
Fda Approval ◽  
Obstructive Sleep

Objective: The purpose of this article is to review the available clinical trial data that led to the Food and Drug Administration (FDA) approval of solriamfetol as well as its role in clinical practice. Data Sources: A MEDLINE/PubMed search was conducted (January 2000 to February 2020) using the keyword solriamfetol to discover appropriate clinical trials. Study Selection and Data Extraction: Articles were included that were published in the English language and related to the FDA approval of solriamfetol or provided novel information regarding this drug entity. Data Synthesis: The findings of the review show that solriamfetol may be a safe and effective option for the treatment of excessive sleepiness (ES) related to narcolepsy and obstructive sleep apnea (OSA). Relevance to Patient Care and Clinical Practice: Solriamfetol is distinguished from other stimulants in that it has lower binding affinity to dopamine and norepinephrine transporters and does not have the monoamine-releasing effects of amphetamines at usual therapeutic doses. Because of solriamfetol’s unique mechanism of action, there may be a reduction in abuse potential compared with the other currently FDA-approved options. Conclusions: In clinical trials, solriamfetol has shown dose-dependent improvement in wakefulness over placebo and adds another option for clinicians when treating ES in narcolepsy and OSA.

Brexanolone: A Novel Drug for the Treatment of Postpartum Depression

2020 ◽  
pp. 089719002097962
Author(s):  
Edna Patatanian ◽  
David R. Nguyen
Keyword(s):  
Adverse Effects ◽  
Postpartum Depression ◽  
English Language ◽  
Neuronal Excitability ◽  
Data Extraction ◽  
Background Information ◽  
Pharmacologic Therapy ◽  
Loss Of Consciousness ◽  
Efficacy And Safety ◽  
Pubmed Search

Objectives: To review the pharmacology, efficacy, and safety of Brexanolone and define its role in the treatment of postpartum depression. Date Sources: A MEDLINE/PubMed search was conducted (1980-May 2020) using the following keywords: postpartum depression, antidepressants, pharmacologic therapy, drug therapy, and brexanolone to identify relevant articles. Study Selection/Data Extraction: Literature search was limited to human studies published in the English language. Phase I, II, and III studies evaluating the pharmacology, efficacy, safety of brexanolone for postpartum depression were included. Bibliographies of relevant articles evaluating postpartum depression and treatment were reviewed for additional citations and background information. Data Synthesis: Brexanolone is a soluble, proprietary, injectable formulation of allopregnanolone, a neuroactive steroid that modulates neuronal excitability. Allopregnanolone levels increase during pregnancy and decrease substantially after birth. These fluctuations have profound effects on anxiety and depression. Three clinical trials established the efficacy and safety of brexanolone in the treatment of postpartum depression. In all 3 trials, brexanolone had an acceptable safety profile and was well tolerated. The most common adverse effects were loss of consciousness, sedation, dry mouth, headache, dizziness, and flushing. Due to sudden loss of consciousness and excessive sedation, continuous pulse oximetry is recommended. Conclusion: Brexanolone has a novel mechanism of action and appears to be safe and effective for the treatment of moderate to severe postpartum depression. At present, high cost, serious adverse effects, and restricted access may limit its use in clinical practice.

scholarly journals 0907 Implementation Of Pathway For Severe Obstructive Sleep Apnea Management In Children

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A345-A345
Author(s):  
S Gehring ◽  
L Auricchio ◽  
S Kidwell ◽  
K Oppy ◽  
S Smallwood ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Health Care Providers ◽  
Therapeutic Option ◽  
Sleep Medicine ◽  
Close Monitoring ◽  
Severe Obstructive Sleep Apnea ◽  
Care Providers ◽  
Oxygen Supplementation ◽  
Obstructive Sleep

Abstract Introduction Obstructive Sleep Apnea (OSA) is associated with neuro-cognitive, cardiovascular and metabolic morbidity in children. Adeno-tonsillectomy is the first line of treatment for OSA with PAP therapy and Oxygen supplementation being alternative therapeutic options in select cases. Severe Obstructive Sleep Apnea is a known risk factor for postoperative respiratory complications after adenotonsillectomy. Therefore, inpatient adenotonsillectomy with close monitoring is recommended for this group of children. Challenges to safe and timely care for this high risk group of children can be overcome with effective coordination of care between different locations and health care providers. Methods All children seeking treatment at Dayton Children’s Division of Sleep Medicine were managed through a pathway developed by a multi-disciplinary team involving sleep medicine, otolaryngology and clinical logistics. Severe OSA was defined as AHI ≥15 events/hr (children <2 year old), AHI ≥15 events/hr with three or more Oxygen desaturations <80% (children ≥2 to <6 years old), AHI ≥ 30 events/hr with three or more Oxygen desaturations <80% (Children ≥6 to 18 years old). Results A total of 78 children were diagnosed with severe OSA in 2019. All children were successfully triaged to appropriate therapeutic option (Adenonotonsillectomy, PAP, O2) within 24 hours of diagnosis. Urgent adenotonsillectomy was performed on the same day in 4 children and within 2 weeks on 12 children. There was no postoperative respiratory complication after urgent adenotonsillectomy. Thirteen children had adenotonsillectomy after 2 weeks. PAP therapy was started in 28 children (34%). Therapy was initiated on the same day in 10 children and the next day on one child. Oxygen supplementation was started in 21 children (27%). Conclusion A multidisciplinary collaborative approach can result in delivery of timely and safe care for severe OSA in children. Support NA

Effect of Sleep Disturbances on Blood Pressure

Hypertension ◽  
2021 ◽  
Author(s):  
Nour Makarem ◽  
Carmela Alcántara ◽  
Natasha Williams ◽  
Natalie A. Bello ◽  
Marwah Abdalla
Keyword(s):  
Blood Pressure ◽  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Shift Work ◽  
Health Care Providers ◽  
Sleep Disturbances ◽  
Care Providers ◽  
Short Sleep ◽  
Hypertension Risk ◽  
Obstructive Sleep

This review summarizes recent literature addressing the association of short sleep duration, shift work, and obstructive sleep apnea with hypertension risk, blood pressure (BP) levels, and 24-hour ambulatory BP. Observational studies demonstrate that subjectively assessed short sleep increases hypertension risk, though conflicting results are observed in studies of objectively assessed short sleep. Intervention studies demonstrate that mild and severe sleep restriction are associated with higher BP. Rotating and night shift work are associated with hypertension as shift work may exacerbate the detrimental impact of short sleep on BP. Further, studies demonstrate that shift work may increase nighttime BP and reduce BP control in patients with hypertension. Finally, moderate to severe obstructive sleep apnea is associated with hypertension, particularly resistant hypertension. Obstructive sleep apnea is also associated with abnormal 24-hour ambulatory BP profiles, including higher daytime and nighttime BP, nondipping BP, and a higher morning surge. Continuous positive airway pressure treatment may lower BP and improve BP dipping. In conclusion, efforts should be made to educate patients and health care providers about the importance of identifying and treating sleep disturbances for hypertension prevention and management. Empirically supported sleep health interventions represent a critical next step to advance this research area and establish causality.

Integrative Sleep Medicine

2021 ◽  
Keyword(s):  
Circadian Rhythm ◽  
Sleep Disorders ◽  
Health Care Providers ◽  
Sleep Disturbances ◽  
Well Being ◽  
Sleep Medicine ◽  
Whole Body ◽  
Care Providers ◽  
Obstructive Sleep ◽  
The Many

Sleep is one of the key underpinnings of human health, yet sleep disturbances and impaired sleep are rampant in modern life. Healthy sleep is a whole-body process impacted by circadian rhythm, daily activities, and emotional well-being, among others. When properly aligned, these work in concert to produce restorative and refreshing sleep. When not in balance, however, sleep disorders result. Yet too often, the approach to treatment of sleep disorders is compartmentalized, failing to recognize all of the complex interactions that are involved. This text offers a comprehensive approach to sleep and sleep disorders by delineating the many factors that interplay into healthy sleep. Health care providers can learn how to better manage their patients with sleep disorders by integrating complementary and conventional approaches. Using an evidence-based approach throughout, this book describes the basics of normal sleep then delves into the foundations of integrative sleep medicine, including the circadian rhythm, mind/body-sleep connection, light, dreaming, the gastrointestinal system, and botanicals/supplements. Specific sleep issues and disorders are then addressed from an integrative perspective, including insomnia, obstructive sleep apnea, sleep related movement disorders, and parasomnias.

Providing Patients with Written Medication Information

1998 ◽  
Vol 32 (9) ◽  
pp. 962-969 ◽  
Author(s):  
Marcia L Buck
Keyword(s):  
English Language ◽  
Reading Skills ◽  
Healthcare Professionals ◽  
Data Extraction ◽  
Search Term ◽  
Care Providers ◽  
Specific Patient ◽  
Medline Search ◽  
Use Of Resources ◽  
Medication Information

OBJECTIVE: To review the literature and provide recommendations for the development and dissemination of written medication information to patients and their care providers. DATA SOURCES: A MEDLINE search (1966–1997) of the English-language literature was performed to identify articles pertaining to the development or use of written medication information. A search of the Internet was conducted by using Yahoo as the guide and “medication information” as the search term. Additional resources were obtained through texts, bibliographies, and catalogs from medical publishers. DATA EXTRACTION: Reports documenting the creation and use of written medication information systems were reviewed, as well as studies of readability and reading skills assessment. Examples of materials available for purchase by laypeople and healthcare providers were also examined. DATA SYNTHESIS: Current statistics support the widespread availability of written medication information for patients and care providers. The goal set forth by the Food and Drug Administration of having 75% of patients receive written information by the year 2000 appears achievable. However, there are still many issues to address. Content is not standardized, and materials are frequently written at reading levels higher than that of the average patient. The development and use of resources requiring only minimal reading skills and an increase in the availability of materials written in Spanish are needed. CONCLUSIONS: Written medication information provides a useful addition to counseling by healthcare professionals. A wide variety of prepared materials is available, as well as resources for those interested in developing tools for a specific patient, population, or setting. Healthcare professionals should be aware of the limitations of some resources. Content and readability must be appropriate for the intended audience for these tools to serve a useful role in patient education.

Current Practices of Antiseptic Use in Canadian Neonatal Intensive Care Units

2018 ◽  
Vol 36 (02) ◽  
pp. 141-147 ◽  
Author(s):  
Helen McCord ◽  
Elise Fieldhouse ◽  
Walid El-Naggar
Keyword(s):  
Intensive Care ◽  
Adverse Effects ◽  
Intensive Care Units ◽  
Health Care Providers ◽  
Neonatal Intensive Care ◽  
Chlorhexidine Gluconate ◽  
Neonatal Intensive Care Units ◽  
Care Providers ◽  
Level Ii ◽  
Canadian Provinces

Objective This article assesses the degree of variability in the current practice of skin antiseptics used in Canadian neonatal intensive care units (NICUs) and different experiences related to each antiseptic used. Methods An anonymous survey was distributed to a clinical representative of each of the 124 Canadian level II and level III NICUs. Results One hundred and two respondents (82.2%), representing all Canadian provinces, completed the survey. Chlorhexidine gluconate with/without alcohol was the antiseptic most used (96%) and the antiseptic with the highest reported adverse effects (68% reported skin burns/breakdown). Other antiseptics used include povidone-iodine (35%) and isopropyl alcohol (22%). Specific guidelines for antiseptic use were available in only 50% of the units with many NICUs lacking gestational and/or chronological age restrictions. Only 23% of responders believed that there was awareness among health care providers of the adverse effects of antiseptics used. Less than half (43%) were completely satisfied with the antiseptics used in their units. Conclusion Chlorhexidine gluconate is the most commonly used antiseptic in Canadian NICUs. The high number of associated adverse effects and the lack of guidelines regulating antiseptic use are of concern. Large clinical trials are urgently needed to guide practice and improve the safety of antiseptics.

Ramipril for the Prevention and Treatment of Cardiovascular Disease

2003 ◽  
Vol 37 (3) ◽  
pp. 412-419 ◽  
Author(s):  
April D Vuong ◽  
Laura G Annis
Keyword(s):  
Heart Failure ◽  
Cardiovascular Disease ◽  
Ace Inhibitors ◽  
English Language ◽  
Ace Inhibitor ◽  
Data Extraction ◽  
Left Ventricular ◽  
Current Evidence ◽  
Pubmed Database ◽  
Prevention And Treatment

OBJECTIVE: To evaluate the effectiveness of ramipril in the prevention and treatment of cardiovascular disease and determine its need for inclusion on a formulary. DATA SOURCES: A MEDLINE and PubMed database search was conducted (1987–May 2002). Only journals written in the English language were selected for review. DATA EXTRACTION AND STUDY SELECTION: Articles reporting the use of ramipril in humans were evaluated. Emphasis was placed on randomized, controlled trials assessing efficacy. DATA SYNTHESIS: Ramipril is an angiotensin-converting enzyme (ACE) inhibitor that exerts its effects through inhibition of the renin–angiotensin–aldosterone system. It exhibits a safety profile that is similar to that of other ACE inhibitors and is comparable in cost to the majority of the available agents. Clinical trials have proven the effectiveness of ACE inhibitors in the treatment of hypertension, heart failure, and nephropathy. Ramipril, however, is the only ACE inhibitor currently approved for the prevention of cardiovascular events in high-risk patients without evidence of left-ventricular dysfunction or heart failure, based on the results of the HOPE (Heart Outcomes Prevention Evaluation) trial. Whether this effect is specific to ramipril has yet to be proven. This article emphasizes the major trials involving ramipril including the AIRE (Acute Infarction Ramipril Efficacy), REIN (Ramipril Efficacy in Nephropathy), and HOPE trials. CONCLUSIONS: Although similar to other ACE inhibitors in many aspects, it cannot be assumed that the benefits shown with ramipril in the HOPE trial are a class effect. Ongoing trials should help to clarify this matter. Until this time, current evidence justifies the inclusion of ramipril on a formulary.

Nilutamide: An Antiandrogen for the Treatment of Prostate Cancer

1997 ◽  
Vol 31 (1) ◽  
pp. 65-75 ◽  
Author(s):  
Ernest J Dole ◽  
Mark T Holdsworth
Keyword(s):  
Prostate Cancer ◽  
Adverse Effects ◽  
Advanced Prostate Cancer ◽  
English Language ◽  
Data Extraction ◽  
Performance Status ◽  
Major Advance ◽  
Improved Performance ◽  
The Impact ◽  
Nonsteroidal Antiandrogens

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and adverse effects of nilutamide and to compare this agent with the currently marketed nonsteroidal antiandrogens (i.e., bicalutamide, flutamide) by critically analyzing the published literature. DATA SOURCES: MEDLINE (1980–1995) and CANCERLIT (1991–1995) were searched for English-language publications using the terms nilutamide, bicalutamide, and flutamide alone, and either nilutamide or androgen antagonists in combination with prostatic neoplasms. STUDY SELECTION AND DATA EXTRACTION: All articles with subject matter on nilutamide, bicalutamide, and flutamide were considered for inclusion. For studies published in more than one journal, the first publication was used unless a subsequent publication included additional or follow-up data, in which case the latter publication was cited instead. DATA SYNTHESIS: Nilutamide was effective in combination with orchiectomy in improving responses in patients with advanced prostate cancer. However, patient survival was not improved in these trials, and improvements in bone pain did not usually result in improved performance status in these patients. The few trials of nilutamide monotherapy or nilutamide in combination with a luteinizing hormone-releasing hormone analog are too small to draw meaningful conclusions regarding its efficacy or its role in the treatment of advanced prostate cancer. No comparative trials of nilutamide with other antiandrogens and no analysis of the impact of nilutamide on patient quality of life are currently available. Nilutamide appears to produce a higher frequency of adverse effects than the other currently marketed nonsteroidal antiandrogens, bicalutamide and flutamide. CONCLUSIONS: Nilutamide does not appear to represent a major advance in the treatment of advanced prostate cancer and appears to be somewhat inferior to both flutamide and bicalutamide with regard to adverse effects. Nilutamide should not be considered the antiandrogen of choice in the treatment of advanced prostate cancer.

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