FDA GUIDELINES AND STATEMENTS
Is NeurOptimal® FDA Approved?
Samantha Diavatis, Director of Operations, Zengar Institute
Quick Links
FDA General Wellness Guidelines
An FDA issued guidance document to help provide clarity on the CDRH’s compliancy policy for general wellness products.
FDA Verbiage Reference Sheet
Learn the types of things we can and can not say in regards to complying with our designation as a General Wellness Product.
The RESEARCH FROM NEUROPTIMAL®
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The relationship between sleep and wake habits and academic performance in medical students: a cross-sectional study By Ahmed S BaHammam, Abdulrahman M Alaseem, Abdulmajeed A Alzakri, Aljohara S Almeneessier, and Munir M Sharif.
Sleep Insufficiency, Sleep Health Problems and Performance in High School Students By Xue Ming, Rebecca Koransky, Victor Kang, Sarah Buchman, Christina E. Sarris, and George C. Wagner.
The Link Between Sleep Quantity and Academic Performance for the College Student By Megan Lowry, Kayla Dean, and Keith Manders.
Priming for self-esteem influences the monitoring of one’s own performance By Sara L. Bengtsson, Raymond J. Dolan, and Richard E. Passingham.
The Effects of Total Sleep Deprivation on Cerebral Responses to Cognitive Performance By Sean P.A. Drummond, PhD, and Gregory G. Brown, PhD.
The Effects of Sleep Extension on the Athletic Performance of Collegiate Basketball Players By Cheri D. Mah, MS, Kenneth E. Mah, MD, MS, Eric J. Kezirian, MD, MPH, and William C. Dement, MD, PhD.
Sleep and athletic performance: the effects of sleep loss on exercise performance, and physiological and cognitive responses to exercise By Fullagar HH, Skorski S, Duffield R, Hammes D, Coutts AJ, Meyer T.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help manage addiction in particular during times of stress.
The Relationship between Stress and Addiction By Afsaneh Hassanbeigi, Jafar Askari, Dordaneh Hassanbeigi, Zahra Pourmovahed
Chronic stress may facilitate the recruitment of habit- and addiction-related neurocircuitries through neuronal restructuring of the striatum By S.B. Taylor, J.M. Anglin, P.R. Paode, A.G. Riggert, M.F. Olive, and C.D. Conrad
Chronic Stress, Drug Use, and Vulnerability to Addiction By Rajita Sinha
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living with ADD/ADHD.
Sleep disturbances in children with attention-deficit/hyperactivity disorder By Karen Spruyt and David Gozal1.
A Clinical Overview of Sleep and Attention-Deficit/Hyperactivity Disorder in Children and Adolescents By Judith A. Owens, MD, MPH.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help families living well with ADHD in particular during times of stress.
Parent stress management training for attention-deficit/hyperactivity disorder By Lee Treacy, GailTripp, Amanda Baird.
Attention Deficit Hyper Activity Disorder (ADHD) and Stress: A Mutual Relationship between Children and Mothers By Mercedeh Samiei, Reza Daneshmand, Rasul Keramatfar, Katayoon Khooshabi, Nasrin Amiri, Yadollah Farhadi, Seyedeh Zeinab Farzadfard, Hamid Kachooi, and Roya Samadi.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living with alzheimers.
Clinical management of sleep disturbances in Alzheimer’s disease: current and emerging strategies By Elena Urrestarazu and Jorge Iriarte.
The brain may clean out Alzheimer’s plaques during sleep By Laura Beil.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help to live with Alzheimer’s.
‘Making the best you can of it’: living with early‐stage Alzheimer’s disease By Hazel MacRae.
The relationship between stress and Alzheimer’s disease By Nicholas J. Justice.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with anxiety in particular during times of stress.
Mindfulness-Based Stress Reduction for Stress Management in Healthy People: A Review and Meta-Analysis By Alberto Chiesa, Alessandro Serretti
Self-confidence and anxiety interpretation: A qualitative investigation By Sheldon Hanton, Stephen D.Mellalieu, and Ross Hall
Mental And Emotional Impact Of Stress By Harry Mills, PhD, Natalie Reiss, PhD and Mark Dombeck, PhD
Effects of Relaxation Therapy on Anxiety Disorders: A Systematic Review and Meta-analysis By Hyeun-sil Kim, Eun Joo Kim
STRESS AND HEALTH: Psychological, Behavioral, and Biological Determinants By Neil Schneiderman, Gail Ironson, and Scott D. Siegel. (Reference #55)
NeurOptimal® helps promote self-confidence, sleep management, stress management and relaxation which as part of a healthy lifestyle, may help manage anxiety.
Relationship Between Self-Concept, Self-esteem, Anxiety, Depression and Academic Achievement in Adolescents By Ali Fathi-Ashtiani, Javad Ejei, Mohammad-Karim Khodapanahi and Hamid Tarkhorani
How Do You Feel? Self-esteem Predicts Affect, Stress, Social Interaction, and Symptom Severity during Daily Life in Patients with Chronic Illness By VANESSA JUTH, JOSHUA M. SMYTH, and ALECIA M. SANTUZZI
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help athletic performance.
Sleep Medication and Athletic Performance—The Evidence for Practitioners and Future Research Directions By Lee Taylor, Bryna C. R. Chrismas, Ben Dascombe, Karim Chamari, and Peter M. Fowler.
Role of sleep in performance and recovery of athletes: A review article By Rachel Venter.
Correlational study of psychological variables self-confidence and anxiety By Gloria González Campos, Javier Cachón Zagalaz, and Santiago Romero Granados.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help maintain a better mood.
Sleep and Mood By the Division of Sleep Medicine at Harvard Medical School
The human emotional brain without sleep — a prefrontal amygdala disconnect By Seung-Schik Yoo, Ninad Gujar, PeterHu, Ferenc A.Joles, and Matthew P.Walker.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well during recovery of a Traumatic Brain Injury.
Stress and Traumatic Brain Injury: A Behavioral, Proteomics, and Histological Study By Sook-Kyung C. Kwon, Erzsebet Kovesdi, Andrea B. Gyorgy, Daniel Wingo, Alaa Kamnaksh, John Walker, Joseph B. Long, and Denes V. Agoston.
Traumatic Brain Injury: What Counselors Need to Know Larry Maucieri, PhD.
The partner’s experience of traumatic brain injury and its recovery By Gerard A Riley.
Traumatic Brain Injury: Unmet Support Needs of Caregivers and Families in Florida By Christina Dillahunt-Aspillaga, Tammy Jorgensen-Smith, Sarah Ehlke, Melanie Sosinski, Douglas Monroe, and Jennifer Thor.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well during recovery of a Traumatic Brain Injury.
Chronic Stress and Fatigue-Related Quality of Life after Mild-to-Moderate Traumatic Brain Injury (TBI) By Esther Bay, PhD ACNS BC, Assistant Professor and Marita B. de-Leon, PhD, Post-doctoral research fellow.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help improve cholesterol levels.
Associations of Usual Sleep Duration with Serum Lipid and Lipoprotein Levels By Yoshitaka Kaneita, MD, Makoto Uchiyama, MD, Nobuo Yoshiike, MD, and Takashi Ohida, MD.
How Lack of Sleep Affects Cholesterol By Rachael Herman.
Lack of Sleep Affects Cholesterol Metabolism and Inflammation By Lila Abassi.
The efficacy of relaxation training in treating anxiety By Pagnini Francesco MS, Manzoni Gian Mauro Psy.D, Castelnuovo Gianluca Ph.D, Molinari Enrico Ph.D.
Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance By Linda Chlan, PhD, RN
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well during times of concussion rehabilitation.
Author links open overlay panel By Mary M. Machulda, Thomas F. Bergquist, Valerie Ito, Stephen Chew.
Stress after a concussion By Fraser Health.
Case Study – Complex Concussion Patients in the MVA System By Canadian Physiotherapy Association.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help improve creativity.
Sleep and Creativity: A Literature Review By Rui Marguilho, Saul Neves de Jesus, João Nuno Viseu, Rita B Domingues, Brandolim Nathália, Nathália Brandolim Becker, Rafaela Dias Matavelli, Raul Quevedo, and Gualberto Buela-Casal.
REM, not incubation, improves creativity by priming associative networks By Denise J. Cai, Sarnoff A. Mednick, Elizabeth M. Harrison, Jennifer C. Kanady, and Sara C. Mednick
Short- and long-term health consequences of sleep disruption By Goran Medic, Micheline Wille, and Michiel EH Hemels
NeurOptimal® helps promote healthy sleep habits, which as part of a healthy lifestyle, may help decision-making skills.
Productivity and Sleep By Tuck.com
The Impact of Sleep Deprivation on Decision Making: A Review By Yvonne Harrison and James A. Home
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with depression in particular during times of stress.*
STRESS AND HEALTH: Psychological, Behavioral, and Biological Determinants By Neil Schneiderman, Gail Ironson, and Scott D. Siegel. (Reference #55)
Surprising Ways Sleep Can Improve Your Health and Life By Susan Biali Haas M.D.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with depression.*
Sleep disorders as core symptoms of depression By David Nutt, DM, FRCP, FRCPsych, FMedSci, Sue Wilson, PhD, and Louise Paterson, PhD
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with headaches (migraines) in particular during times of stress.
Stress symptoms: Effects on your body and behavior By Mayo Clinic Staff.
Headaches: Reduce stress to prevent the pain By Mayo Clinic Staff.
Stress and migraine By Francoise Radat.
Perceived stress in patients with migraine: a case-control study By Hye-Jin Moon, Jong-Geun Seo, and Sung-Pa Park.
The association between stress and headache: A longitudinal population-based study By Sara H Schramm, Susanne Moebus, Nils Lehmann, Ursula Galli, Mark Obermann, Eva Bock, Min-Suk Yoon, Hans-Christoph Diener, and Zaza Katsarava.
The Effects of Stress on Your Body By WebMD.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help maintain a healthy weight.
The Relationship Between Sleep and Weight in a Sample of Adolescents By Leslie A. Lytle, Keryn E. Pasch, and Kian Farbakhsh
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with high blood pressure in particular during times of stress.
Stress and high blood pressure: What’s the connection? By Mayo Clinic Staff.
Managing Stress to Control High Blood Pressure By American Heart Association
Stress and Hypertension: Symptoms and Treatment By The American Institute of Stress
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help lower hyperactivity, inattentiveness and impulsivity in children.
Sleep and children: the impact of lack of sleep on daily life By Reut Gruber, PhD.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help curb inflammation.
The relevance of sleep abnormalities to chronic inflammatory conditions By Z. Ranjbaran, L. Keefer, E. Stepanski, A. Farhadi, and A. Keshavarzian.
Sleep Loss and Inflammation By
Janet M. Mullington, Ph.D., Norah S. Simpson, Ph.D., Hans K. Meier-Ewert, M.D., and Monika Haack, Ph.D.
Investigating the Relationship Between Inflammation and Sleep Quality By Roger McIntyre, MD.
Lack of Sleep Affects Cholesterol Metabolism and Inflammation By Lila Abassi.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with insomnia in particular during times of stress.
Stress and Sleep Disorder By Kuem Sun Han, Lin Kim, and Insop Shim
On the nature of burnout–insomnia relationships: A prospective study of employed adults By Galit Armon, Arie Shirom, Itzhak Shapira, and Samuel Melamed
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help maintain better relationships.
Sleep deprivation impairs recognition of specific emotions By William D.S.Killgore, Thomas J.Balkin, Angela M.Yarnell, Vincent F.Capaldi II.
SOCIAL RELATIONSHIPS AND SLEEP QUALITY By Robert G. Kent, Bert N. Uchino, Matthew R. Cribbet, Kimberly Bowen, and Timothy W. Smith.
Family Relationships and Troubled Sleep among U.S. Adults: Examining the Influences of Contact Frequency and Relationship Quality By Jennifer A. Ailshire and Sarah A. Burgard.
The human emotional brain without sleep — a prefrontal amygdala disconnect By Seung-Schik Yoo, Ninad Gujar, Peter Hu, Ferenc A.Jolesz, Matthew P.Walker.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with Multiple Sclerosis.
Stress and multiple sclerosis: A systematic review considering potential moderating and mediating factors and methods of assessing stress By Laia Briones-Buixassa, Raimon Milà, Josep M. Aragonès, Enric Bufill, Beatriz Olaya, and Francesc Xavier Arrufat.
Stress and multiple sclerosis: A systematic review considering potential moderating and mediating factors and methods of assessing stress By Laia Briones-Buixassa, Raimon Milà, Josep M. Aragonès, Enric Bufill, Beatriz Olaya, and Francesc Xavier Arrufat.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with Multiple Sclerosis.
Relationship between Sleep Quality and Quality of Life in Patients with Multiple Sclerosis By Payam Sarraf, Sepeher Azizi, Abdorreza Naser Moghaddasi, Mohammad Ali Sahraian, Abbas Tafakhori, and Mahsa Ghajarzadeh.
The impact of disability, fatigue and sleep quality on the quality of life in multiple sclerosis By Haleh Ghaem and Afshin Borhani Haghighi.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with OCD in particular during times of stress.
The Importance of Managing Stress When You Have OCD By Owen Kelly, PhD.
The Role of Stress in the Pathogenesis and Maintenance of Obsessive-Compulsive Disorder By Thomas G. Adams, Benjamin Kelmendi, C. Alex Brake, Patricia Gruner, Christal L. Badour, Christopher Pittenger.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with Parkinsons.
Coping processes and health-related quality of life in Parkinson’s disease By R. S. Bucks, K. E. Cruise, T. C. Skinner, A. M. Loftus, R. A. Barker, and M. G. Thomas
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with Parkinsons.
Exacerbated physical fatigue and mental fatigue in Parkinson’s disease By Jau‐Shin Lou MD, PhD, Greg Kearns, BS, Barry Oken, MD, Gary Sexton, PhD, John Nutt, MD.
Sleep Dysfunction and its Management in Parkinson’s Disease By Scott J. Kutscher, MD, Siavash Farshidpanah, MD, and Daniel O. Claassen, MD.
Quality of Sleep in Patients with Parkinson’s Disease By Mohammad Reza Najafi, Ahmad Chitsaz, Zahra Askarian, and Mohammad Amin Najafi.
NeurOptimal® helps promote self confidence, which as part of a healthy lifestyle, may help significantly improved quality of life.
A study of the relationship between quality of life, self-esteem and health By Stephen Kermode and Doug MacLean.
Self-esteem and life satisfaction in adolescents-gender and age as potential moderators By Unni Karin Moksnes and Geir Arild Espnes.
NeurOptimal® helps promote stress management, which as part of a healthy lifestyle, may help living well with tinnitus in particular during times of stress.
Stress and tinnitus—from bedside to bench and back By Birgit Mazurek, Heidemarie Haupt, Heidi Olze, and Agnieszka J. Szczepek.
NeurOptimal® helps promote sleep management, which as part of a healthy lifestyle, may help living well with tinnitus.
Stress and tinnitus—from bedside to bench and back By Birgit Mazurek, Heidemarie Haupt, Heidi Olze, and Agnieszka J. Szczepek.