National Adaptive Trial for PTSD Related Insomnia (NAP)

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ClinicalTrials.gov Identifier: NCT03668041

Recruitment Status : Recruiting

First Posted : September 12, 2018

Last Update Posted : July 9, 2021

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Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

Study Description

Brief Summary:

Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone, eszopiclone, or gabapentin can help decrease symptoms of insomnia in patients with PTSD. PTSD is a form of intense anxiety which sometimes results from severe trauma. Symptoms may include nightmares, flashbacks, troublesome memories, difficulty sleeping, poor concentration, irritability, anger, and emotional withdrawal. Insomnia is a disorder that can make it hard to fall sleep, stay asleep or cause a person to wake up too early and not be able to fall back to sleep.

Condition or disease	Intervention/treatment	Phase
Insomnia	Drug: Trazodone Drug: Eszopiclone Drug: Gabapentin Other: Placebo	Phase 3

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Detailed Description:

VA Cooperative Studies Program #2016 is a double-blind four-arm adaptive clinical trial to compare the efficacy of trazodone hydrochloride, eszopiclone, and gabapentin to placebo, as adjunctive therapies in the treatment of insomnia symptoms among Veterans with military related PTSD, as measured by statistically significant difference in change from baseline in Insomnia Severity Index (ISI) total score at Week 12.

Participants will be approximately 1224 male and female Veterans with PTSD and moderate levels of insomnia as measured on the ISI. Veterans who meet inclusion and exclusion criteria will be randomized within each site to receive trazodone hydrochloride, eszopiclone, gabapentin or placebo. Permuted blocks randomization will be used within each participating site. A mid-point interim analysis will be conducted wherein active treatment arms meeting futility early stopping criteria will be dropped. If all active treatment arms are dropped at the interim analysis, the study is stopped at that time. Otherwise, the study will continue and the remaining sample size will be allocated to the remaining study arms with equal randomization probabilities. Study drug dose will be increased using a flexible dose titration schedule over a period of up to 3 weeks and continued for up to 12 weeks.

The Insomnia Severity Index (ISI) is the primary outcome for this study. The Clinician Administered PTSD Scale for DSM-V (CAPS-5) will be the primary secondary outcome measuring change in PTSD symptoms. Other secondary outcomes that measure PTSD and sleep include the PTSD Checklist (PCL-5) and Pittsburgh Sleep Quality Index Scale-Addendum for PTSD (PSQI-A). Other secondary outcomes include brief questionnaire secondary measures of comorbid depression (PHQ-9), anxiety (GAD-7), quality of life (WHOQOL-BREF), treatment satisfaction questionnaire for medication (TSQM-9), anger and aggression (DAR-5), smoking and alcohol consumption (Timeline Follow-Back, or TLFB), clinical global change (CGI-S), resource utilization (an abbreviated subset of the Service Utilization and Resources Form, or SURF), Columbia Suicide Severity Rating Scale (C-SSRS), optional wearable device (Actiwatch Spectrum Plus by Philips) to measure actigraphy.

This study is designed to serve as a well-powered "screen" for efficacious medications for the treatment of PTSD-related insomnia from among the medications already widely prescribed for this purpose within VA. Thus, this study is powered to detect significant differences between trazodone, eszopiclone, and gabapentin versus placebo. The investigators have powered the study to detect a small effect size, recognizing that the effect size of s-zopiclone is larger ( 0.5) in a small short-term pilot study in PTSD but that the effect size of s-zopiclone declines over time in a well-powered study of primary insomnia, stabilizing at 12 weeks of treatment at a level that is sustained over subsequent months of treatment. Presuming that the widespread prescription rates of these three medications for PTSD patients suggests that they have some efficacy for PTSD-related insomnia, the investigators would expect that the effect size for the comparisons among the active medications would be very small. Therefore, the study is not powered to detect differences among the active medications. The investigators have chosen the ISI as the primary outcome for several reasons: (a) it has excellent psychometric properties, (b) it is feasible (in terms of subject burden and cost) to administer the ISI at multiple timepoints during the 12-week trial, (c) according to the insomnia experts who provided input into the study design it has displaced sleep diary-related measures as the primary outcome in clinical trials for sleep, and d) it has been accepted by the FDA as the primary outcome measure in registration trials.

Based on the literature, an effect size of 0.35 in the primary endpoint (ISI) is plausible and clinically meaningful. The investigators estimated the overall participant dropout rate is between 10% to 15%. With a conservative estimate drop-out rate of 15%, the total sample size will be 1224. From the previous CSP PTSD trials, the investigators anticipate each participating site can randomize on average 1.25 participants per month, or 15 patients per site per year. With 3 years of recruitment, the investigators would need 28 sites to reach sample 1224. The investigators plan to start the study with 32 sites to allow dropping of non-performing sites.

VA bears a unique responsibility for addressing the limited efficacy of current evidence-based pharmacotherapy practices for PTSD. Since 2001, there have been only two FDA-approved medications for PTSD, both serotonin reuptake inhibiting antidepressants (SRIs), and SRIs have limited efficacy for military-related PTSD. This "efficacy gap" results in widespread polypharmacy for PTSD in VA, such that Veterans with antidepressant-resistant symptoms are treated, on average, with more than three psychotropic medications that present risks without clear benefit. In particular, SRI-resistant insomnia in military-related PTSD is a significant problem for VA, with 88% of these patients reporting clinically significant sleep impairment. In PTSD, sleep disturbances contribute importantly to impairments in quality of life, reduced social and vocational function, suicide risk, and poorer health. Effective treatment of persisting insomnia in PTSD is a sufficiently serious unmet need that the 2017 VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder, called for "studies of non-benzodiazepine sedative/hypnotics." The purpose of the study is address this gap through testing the efficacy of three non-benzodiazepine hypnotics in comparison to placebo, representing the three medications or medication classes that are most commonly prescribed to Veterans with PTSD on an off-label basis and have yet to be tested in a definitive clinical trial. A novel aspect of this study is its implementation of an adaptive design in which arms would be dropped for evidence of futility based on pre-specified criteria at a designated interim analysis, intended to increase the efficiency of the trial and thereby improve the feasibility of its ambitious aim. The VA Cooperative Studies Program is uniquely suited to conduct this study.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1224 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	CSP #2016 - National Adaptive Trial for PTSD Related Insomnia
Actual Study Start Date :	February 25, 2021
Estimated Primary Completion Date :	June 25, 2024
Estimated Study Completion Date :	June 25, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Trazodone

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Trazodone Participants who are assigned to take trazodone, an active study medication.	Drug: Trazodone Trazodone is approved by the Food and Drug Administration (FDA) for treating major depression in adults but not for PTSD. Although trazodone has not been approved by the FDA to treat insomnia or PTSD, some doctors have tried it for these purposes. The doses in this study will be lower than the doses used to treat depression.
Active Comparator: Eszopiclone Participants who are assigned to take eszopiclone, an active study medication.	Drug: Eszopiclone Eszopiclone is approved by the FDA for treating insomnia, but it's unknown if eszopiclone can help treat insomnia when it's related to PTSD. Some doctors have tried it for this purpose. The doses in this study will be the same as the doses used to treat insomnia. A small study found it to be helpful for treating patients with PTSD.
Active Comparator: Gabapentin Participants who are assigned to take gabapentin, an active study medication.	Drug: Gabapentin Gabapentin is an FDA approved medication for the treatment of seizures, a type of nerve pain and some forms of chronic pain. Some doctors have prescribed it for insomnia. While the total daily doses in this study are less than the usual total daily dose, the highest dose of gabapentin used in this study will be higher than the typical dose taken at a single time. Doses even higher than this have been taken and observed to be acceptable for treating patients with PTSD.
Placebo Comparator: Placebo Participants who are assigned to take a placebo, a non-active study medication.	Other: Placebo The active study medications listed above will be compared with a placebo, which is a pill that looks like a study medication but has no medication in it.

Outcome Measures

Primary Outcome Measures :

Insomnia Severity Index [ Time Frame: Baseline to 12 weeks ]
Change in the Insomnia Severity Index score from baseline to the 12-week follow-up will serve as the primary outcome. Possible range for ISI 0-28. Higher score indicates more severe insomnia problem(s).

0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)

Secondary Outcome Measures :

Clinician Administered PTSD Scale for DSM-5 [ Time Frame: 12 weeks ]
The scale consists of 20 DSM-5 symptoms rated on a 0-4 scale of how much that symptom bothered the individual in the prior month. Possible range for CAPS-5 total score 0-80, CAPS symptom cluster subscores of: Re-experiencing (B) 0-20, Avoidance (C) 0-8, Alteration in Cognition and Mood (D) 0-28, Hyperarousal (E) 0-24, Significant Distress (G) 0-12, and Dissociation (I) 0-8. Higher score indicates more severe PTSD.
Pittsburgh Sleep Quality Index Scale-Addendum for PTSD [ Time Frame: 12 weeks ]
It is a self-administered questionnaire that assesses sleep quality and disturbances over a 1-month period of time. The 7 items in the addendum generate a summary score, with three additional questions if memories or nightmares of a traumatic experience are present. Possible range for PSQI-A score 0-21, and possible range for each item 0-3. Higher PSQI-A score indicates worse quality of sleep.
Patient Health Questionnaire-9 [ Time Frame: 12 weeks ]
It is a tool to measure comorbid depression. This scale is frequently used in VA settings, has been well validated, and is a quick self-administered questionnaire. Possible range for PHQ-9 0-27. Higher score indicates more severe depression. 0-4: None/Minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, 20-27: Severe depression.
The World Health Organization Quality of Life [ Time Frame: 12 weeks ]
It is a 26-item self-administered questionnaire scaled to assess functioning and quality of life. Possible range for WHOQOL-BREF Overall 4-20, WHOQOL-BREF domain subscores of: Physical Health 4-20, Psychological 4-20, Social Relationships 4-20, and Environment 4-20. Higher score indicates better satisfaction with life.
Treatment Satisfaction Questionnaire for Medication-9 [ Time Frame: 12 weeks ]
It is a 9-item questionnaire to measure treatment satisfaction. TSQM-9 are scored on 3 domains: Effectiveness, Convenience, Global Satisfaction. Possible range for TSQM-9 domain scores 0-100. Higher score indicates higher satisfaction with medication.
Service Utilization and Resources Form [ Time Frame: 12 weeks ]
An abbreviated subset of the Service Utilization and Resources Form (SURF) assessment will be used to evaluate alcohol and other substance use (cannabis, smoking, and caffeine) using Timeline Follow-Back and resource utilization (e.g., outpatient medical and/or psychiatric visits and use of inpatient treatment and housing services). Questionnaire; no summary score.
PTSD Checklist [ Time Frame: 12 weeks ]
It is a brief questionnaire measure of PTSD symptom severity that is widely used within and outside VA. Possible range for PCL-5 0-80. Higher score indicates greater propensity for chronic and delayed PTSD.
Generalized Anxiety Disorder-7 Scale [ Time Frame: 12 weeks ]
It is a self-administered tool to assess anxiety. Possible range for GAD-7 0-21. Higher score indicates more severe anxiety disorder. 0-4: None/Minimal anxiety, 5-9: Mild Anxiety, 15-21: Severe anxiety.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to comprehend and provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study (approximately 17 weeks from the date of being randomized)
Male or female, between the ages of 18 and 75 years
Allow digital recording of phone interviews
Military service connected PTSD
Primary DSM-5 diagnosis of PTSD, assessed by structured interview using the CAPS-5
Total CAPS-5 score 26
ISI >15
Screening clinical laboratory tests without clinically significant abnormalities as determined by the site investigator with input, if needed, from the study chair
Electrocardiogram (ECG) at baseline without clinically significant abnormalities and/or contingent upon approval by consulting medical physician.
Females of childbearing potential:
1. Must have a negative pregnancy test during screening
2. Must agree not to become pregnant or breastfeed during the course of the study
3. Must be willing to use a reliable form of contraception for 16 weeks (during study treatment and for 2 weeks after taking the last dose) which includes: barrier contraceptives (male or female condoms with or without a spermicide, diaphragm or cervical cap with spermicide, or intrauterine device) and hormone-based therapy (contraceptive pills, intrauterine devices, or Depo-Provera�)
4. Birth control for female participants is not necessary if surgically sterile or if with a partner with whom they are not capable of conceiving children (defined as a surgically sterile female by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; surgically sterile male who has undergone a complete orchiectomy or successful vasectomy; or a same sex partner)

11. Agree to secure firearms while receiving study treatment 12. If individuals are undergoing evidence-based psychotherapy which includes: cognitive behavioral therapy (CBT), cognitive processing therapy (CPT), prolonged exposure therapy (PE), and/or stress inoculation therapy (SIT), they must have started these therapies at least 30 days prior to starting screening. (Supportive individual and group therapy is allowed) 13. Agreement to adhere to Lifestyle Considerations throughout study participation

Exclusion Criteria:

Currently enrolled in any other interventional study unless prior approval is provided by the study team (It is a CSP policy that exemptions will be assessed for individual patients on a case-by-case basis. Exemptions require the agreement in writing of the following individuals or groups: (1) the SI of both studies; (2) the Study Chairs of the involved studies; (3) the appropriate CSP Center Director(s); and (4) the VA Central IRB.)
Allergy and/or history of intolerance to trazodone hydrochloride, gabapentin, and/or eszopiclone
A comorbid current or lifetime diagnosis of bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia or delusional disorder, or current comorbid diagnosis of schizophreniform disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder or psychotic disorder not otherwise specified (NOS) according to Structured Clinical Interview for DSM-5 (SCID)-I-RV/P
Clinical evidence of inadequately treated sleep apnea as detected by using ApneaLink to assess the presence of sleep apnea or not
History of moderate or severe traumatic brain injury (TBI) or history of gross structural damage as shown on MRI (occurring during period of military service).
Positive urine test for an illicit substance, excluding cannabis, within the past 90 days prior to screening
Substance use meeting DSM-5 criteria for moderate or severe dependence (excluding nicotine) within the past 12 months prior to screening. (Note: Current mild dependence for alcohol and cannabis use is acceptable, but current mild dependence of any other substances is exclusionary).
Inpatient psychiatric hospitalization within 30 days prior to randomization
Suicidal or homicidal ideation with intent or plan to harm themselves or others within 90 days prior to randomization
Creatinine clearance (CrCl) less than 60 mL/min, or chronic liver disease with two or more of the following occurring within the past six months: international normalized ratio (INR) greater than or equal to 1.7 (not on warfarin therapy), bilirubin greater than or equal to 2 mg/dL, serum albumin less than or equal to 3.5 g/dL, ascites, or encephalopathy (Participants can be reevaluated in 30 days)
Clinical and laboratory evidence of untreated hypothyroidism or hyperthyroidism
A corrected QT (QTc) interval greater than 470 ms
Unstable, serious medical condition or one requiring acute medical treatment, or planned hospitalization for extended care
Dementia, epilepsy, stroke, or current treatment with warfarin for anticoagulation
Taking any of the exclusionary medications listed in Appendix A. Note- an individual taking one of these medications for the sole purpose of improving sleep that elects to undergo an adequate wash-out period of at least 5 half-lives of the parent compound or active metabolite (e.g., for medications like diazepam), under the care of the individual's clinical provider, wouldn't be excluded by this criterion.
Under criminal investigation or pending legal charges with potential incarceration
Individuals who lack stable contact information (including lack of a telephone number)
Participants who anticipate working during the hours of midnight to 6am during the course of study trial

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668041

Contacts

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Contact: Beverly A Ventura	(650) 493-5000 ext 22303	beverly.ventura@va.gov

Locations

Show 35 study locations

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United States, Alabama
Birmingham VA Medical Center, Birmingham, AL	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ripu Jindal, MD 205-933-8101 ext 4734
Tuscaloosa VA Medical Center, Tuscaloosa, AL	Recruiting
Tuscaloosa, Alabama, United States, 35404
Contact: Patricia Pilkinton, MD 205-554-2000 ext 2944
United States, Arizona
Phoenix VA Health Care System, Phoenix, AZ	Recruiting
Phoenix, Arizona, United States, 85012
Contact: Shabnam Thompson, DO 602-277-5551 ext 5255
United States, California
VA Loma Linda Healthcare System, Loma Linda, CA	Not yet recruiting
Loma Linda, California, United States, 92357
Contact: Ronald Fernando, MD 909-583-6201
VA Long Beach Healthcare System, Long Beach, CA	Recruiting
Long Beach, California, United States, 90822
Contact: Larry Albers, MD 562-826-8000 ext 2150
VA Palo Alto Health Care System, Palo Alto, CA	Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Steven Lindley, MD 650-493-5000 ext 25189
VA San Diego Healthcare System, San Diego, CA	Recruiting
San Diego, California, United States, 92161
Contact: Sanjai Rao, MD 858-552-8585 ext 1270
San Francisco VA Medical Center, San Francisco, CA	Recruiting
San Francisco, California, United States, 94121
Contact: William Wolfe, MD 415-221-4810 ext 24348
United States, Connecticut
CERC (VISN1, West Haven, CT)	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Gihyun Yoon, MD 203-932-5711 ext 7421
VA Connecticut Healthcare System West Haven Campus, West Haven, CT	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Jennifer Vessicchio, LCSW-C 203-932-5711 ext 5350 jennifer.vessicchio@yale.edu
Study Chair: John H. Krystal, MD
United States, Florida
Bay Pines VA Healthcare System, Pay Pines, FL	Recruiting
Bay Pines, Florida, United States, 33744
Contact: Celeste Nadal, MD 727-398-6661 ext 207532
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA	Recruiting
Decatur, Georgia, United States, 30033
Contact: Erica Duncan, MD 404-321-6111
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL	Recruiting
Hines, Illinois, United States, 60141-5000
Contact: Timothy Buckley, MD 708-202-8387 ext 22470
United States, Louisiana
Overton Brooks VA Medical Center, Shreveport, LA	Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Ronald Schneider, MD 318-990-5317
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Not yet recruiting
Boston, Massachusetts, United States, 02130
Contact: Lynn DeLisi, MD 774-826-3155
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN	Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Joseph Westermeyer, MD 612-467-3961
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM	Not yet recruiting
Albuquerque, New Mexico, United States, 87108-5153
Contact: Geraldo Villarreal, MD 505-265-1711 ext 4936
United States, North Carolina
Asheville VA Medical Center, Asheville, NC	Recruiting
Asheville, North Carolina, United States, 28805
Contact: James Michalets, MD 828-298-7911 ext 5286
Durham VA Medical Center, Durham, NC	Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Michael Hertzberg, MD 919-268-0411 ext 7967
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC	Not yet recruiting
Salisbury, North Carolina, United States, 28144
Contact: Robin Hurley, MD 704-638-9000 ext 14455
United States, Ohio
Cincinnati VA Medical Center, Cincinnati, OH	Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Jacob Forrester, MD 513-861-3100 ext 3260
Louis Stokes VA Medical Center, Cleveland, OH	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Dietrich Schelzig, MD 216-791-3800 ext 820
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Thase, MD 215-823-5903
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Isabella Soreca, MD 412-688-6000
United States, Rhode Island
Providence VA Medical Center, Providence, RI	Recruiting
Providence, Rhode Island, United States, 02908
Contact: Robert Swift, MD 401-273-7100 ext 3473
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC	Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Mark Hamner, MD 843-789-7799 ext 7799
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Recruiting
Dallas, Texas, United States, 75216
Contact: Geetha Shivakumar, MD 214-857-1014
Michael E. DeBakey VA Medical Center, Houston, TX	Recruiting
Houston, Texas, United States, 77030
Contact: Ricardo Jorge, MD 713-791-1414
South Texas Health Care System, San Antonio, TX	Recruiting
San Antonio, Texas, United States, 78229
Contact: Muhammad Baig, MD 210-617-5300 ext 18244
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT	Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Jennifer Romesser, PsyD 801-582-1565 ext 42711
United States, Vermont
White River Junction VA Medical Center, White River Junction, VT	Recruiting
White River Junction, Vermont, United States, 05009-0001
Contact: Paul Holtzheimer, MD 802-295-9363 ext 6042
United States, Virginia
Salem VA Medical Center, Salem, VA	Recruiting
Salem, Virginia, United States, 24153
Contact: Anjali Varma, MD 540-982-2463 ext 3555
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA	Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Deepika Agrawal, MD 253-583-1692
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI	Recruiting
Madison, Wisconsin, United States, 53705
Contact: Timothy Juergens, MD 608-256-1901 ext 11304
Clement J. Zablocki VA Medical Center, Milwaukee, WI	Not yet recruiting
Milwaukee, Wisconsin, United States, 53295-1000
Contact: Elizabeth Nilsson, MD 414-384-2000 ext 41675

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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Study Chair:	John H. Krystal, MD	VA Connecticut Healthcare System West Haven Campus, West Haven, CT

More Information

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Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT03668041
Other Study ID Numbers:	2016
First Posted:	September 12, 2018 Key Record Dates
Last Update Posted:	July 9, 2021
Last Verified:	July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Gabapentin Trazodone Eszopiclone Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Anti-Anxiety Agents	Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents Hypnotics and Sedatives Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents

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