Corresponding Author: Charles M. Morin, PhD, École de Psychologie, Université Laval, 2325, rue des Bibliothèques, Québec, QC G1V 0A6, Canada (email@example.com).
Accepted for Publication: April 18, 2020.
Published Online: July 8, 2020. doi:10.1001/jamapsychiatry.2020.1767
Author Contributions: Drs Morin and Edinger had access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Morin and Edinger were principal investigators.
Concept and design: Morin, Edinger, Krystal, Belanger.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Morin, Edinger, Beaulieu-Bonneau, Simmons.
Critical revision of the manuscript for important intellectual content: Morin, Beaulieu-Bonneau, Ivers, Krystal, Guay, Belanger, Cartwright, Lamy, Busby.
Statistical analysis: Ivers.
Obtained funding: Morin, Edinger, Krystal.
Administrative, technical, or material support: Morin, Edinger, Beaulieu-Bonneau, Krystal, Simmons, Lamy.
Supervision: Morin, Edinger, Ivers, Guay, Belanger, Lamy.
Conflict of Interest Disclosures: Dr Morin has served as a consultant for Abbot, Eisai, Merck, Philips, and Weight Watchers and received research support from Idorsia and Canopy Health. Dr Edinger has received research support from Merck and Philips/Respironics. Ms Cartwright received research grant support from the National Institutes of Health, Janssen, Jazz Axsome, and Reveal Biosensors and served as a consultant to Eisai, Ferring, Galderma, Harmony Biosciences, Idorsia, Jazz, Janssen, Takeda, Merck, Neurocrine, Pernix, and Physician’s Seal. Dr Krystal reported grants from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Axsome, and Reveal Biosensors; grants and personal fees from Janssen, Jazz, personal fees from Evecxia; and personal fees from Sage, Ferring, Galderma, Harmony Biosciences, Eisai, Idorsia, Neurocrine, Merck, and Takeda outside the submitted work. No other disclosures were reported.
Funding/Support: This study was funded by the National Institute of Mental Health (MH091053).
Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Information: The Data and Safety Monitoring Board (DSMB) was composed of 3 members including Daniel Almirall (Chair), Vaughn McCall, and Richard Bootzin. The DSMB committee was responsible for safeguarding the interests of study participants, assessing the safety and efficacy of study procedures, and monitoring the overall conduct of the study. The DSMB completed an annual review of the trial conduct. This committee was independent from the sponsor and declared no competing interests.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013.
M , Morin
CM , LeBlanc
M , Grégoire
JP , Savard
J . The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep
. 2009;32(1):55-64.PubMedGoogle Scholar
A , Kansagara
D , Forciea
MA , Cooke
M , Denberg
TD ; Clinical Guidelines Committee of the American College of Physicians. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med
. 2016;165(2):125-133. doi:10.7326/M15-2175PubMedGoogle ScholarCrossref
MJ , Buysse
DJ , Krystal
AD , Neubauer
DN , Heald
JL . Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med
. 2017;13(2):307-349. doi:10.5664/jcsm.6470PubMedGoogle ScholarCrossref
SJ , Nutt
DJ , Alford
et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders. J Psychopharmacol
. 2010;24(11):1577-1601. doi:10.1177/0269881110379307PubMedGoogle ScholarCrossref
R , Bao
J , Zhang
C , Deng
J , Long
C . Comparison of sleep condition and sleep-related psychological activity after cognitive-behavior and pharmacological therapy for chronic insomnia. Psychother Psychosom
. 2006;75(4):220-228. doi:10.1159/000092892PubMedGoogle ScholarCrossref
CM , Edinger
JD , Krystal
AD , Buysse
DJ , Beaulieu-Bonneau
S , Ivers
H . Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial. Trials
. 2016;17(1):118. doi:10.1186/s13063-016-1242-3PubMedGoogle ScholarCrossref
AJ , Saskin
P , Thorpy
MJ . Treatment of chronic insomnia by restriction of time in bed. Sleep
. 1987;10(1):45-56.PubMedGoogle Scholar
RR , Epstein
D , Wood
JM . Stimulus Control Instructions. In: Hauri
P , ed. Case Studies in Insomnia
. Plenum Press; 1991:19-28. doi:10.1007/978-1-4757-9586-8_2
CM , Espie
CA . Insomnia: A Clinical Guide to Assessment and Treatment. Kluwer Academic/Plenum; 2003.
EF , Kalali
AH , Reites
J . Current status of hypnotic prescribing habits in the United States. Psychiatry (Edgmont)
. 2007;4(9):24-25.PubMedGoogle Scholar
TJ , MacDonald
R , Brasure
et al. Pharmacologic treatment of insomnia disorder: an evidence report for a clinical practice guideline by the american college of physicians. Ann Intern Med
. 2016;165(2):103-112. doi:10.7326/M15-1781PubMedGoogle ScholarCrossref
European Medicines Agency (EMA). Guideline on Adjustment for Baseline Covariates in Clinical Trials (No. EMA/CHMP/295050/2013). European Medicines Agency; 2015.
AG , Dong
L , Bélanger
L , Morin
CM . Mediators and treatment matching in behavior therapy, cognitive therapy and cognitive behavior therapy for chronic insomnia. J Consult Clin Psychol
. 2017;85(10):975-987. doi:10.1037/ccp0000244PubMedGoogle ScholarCrossref