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This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75 mg - 300 mg of JZP-110 | Other | Once Daily Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP-110 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) Score | Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period. | Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) | Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) |
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Major Inclusion Criteria:
Subject meets one of the following:
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Pulmonary Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36084494 | Derived | Malhotra A, Strollo PJ Jr, Pepin JL, Schweitzer P, Lammers GJ, Hedner J, Redline S, Chen D, Chandler P, Bujanover S, Strohl K. Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. Sleep Med. 2022 Dec;100:165-173. doi: 10.1016/j.sleep.2022.08.005. Epub 2022 Aug 14. | |
| 34606437 |
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A total of 645 subjects were enrolled in the study; 2 subjects withdrew from the study prior to receiving study drug. A total of 643 subjects received at least 1 dose of JZP-110 in the open-label phase and were included in the Safety Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | JZP-110 | Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2016 | Apr 19, 2019 |
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| Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) | Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| UC San Diego Medical Center | La Jolla | California | 92037 | United States |
| So Cal Institute For Respiratory Diseases, Inc. | Los Angeles | California | 90048 | United States |
| Pacific Sleep Medicine | Oceanside | California | 92054 | United States |
| The Research Center of Southern California | Oceanside | California | 92056 | United States |
| Stanford University Center for Narcolepsy | Redwood City | California | 94063 | United States |
| Pacific Research Network Inc. | San Diego | California | 92103 | United States |
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | United States |
| Critical care Pulmonary & Sleep Associates, LLC | Lakewood | Colorado | 80228 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | United States |
| Clinical Research Group of St. Petersburg | St. Petersburg | Florida | 33707 | United States |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | United States |
| Emory Sleep Center | Atlanta | Georgia | 30329 | United States |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30342 | United States |
| SleepMed of Central Georgia | Macon | Georgia | 31201 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Illinois at Chicago Nursing School | Chicago | Illinois | 60612 | United States |
| Rowe Neurology Institute RNI - Lenexa | Lenexa | Kansas | 66214 | United States |
| Veritas Clinical Specialties LTD | Topeka | Kansas | 66606 | United States |
| Kentucky Research Group | Louisville | Kentucky | 402318 | United States |
| Advanced Neurodiagnostic Center | Metairie | Louisiana | 70006 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | United States |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Neurocare, Inc. | Newton | Massachusetts | 24590 | United States |
| Henry Ford Hospital Sleep Disorders & Research Center | Detroit | Michigan | 48202 | United States |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | United States |
| Minnesota Lung Center | Edina | Minnesota | 55435 | United States |
| Sleep Medicine & Research center, St. Lukes Hospital | Chesterfield | Missouri | 63017 | United States |
| University of Missouri | Columbia | Missouri | 65201 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| Clinilabs | New York | New York | 10019 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Hickory Research Center | Hickory | North Carolina | 28602 | United States |
| Hickory Research Center, ARSM Research, LLC | Huntersville | North Carolina | 28078 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Northcoast Clinical Trials Inc. | Beachwood | Ohio | 44122 | United States |
| Sleep Management Institute | Cincinnati | Ohio | 45245 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45255 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Southwest Cleveland Sleep Research Center | Cleveland | Ohio | 44130 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio Sleep Medicine & Neuroscience Institute | Dublin | Ohio | 43017 | United States |
| Mercy St. Anne & Mercy St. Charles Sleep Disorders Center | Toledo | Ohio | 43606 | United States |
| Center for Sleep and Circadian Neurobiology | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Sleep Medicine Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Lowcountry Lung Critical Care | Charleston | South Carolina | 29406 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Sleep Med of South Carolina Clinical Research Solutions | Columbia | South Carolina | 29201 | United States |
| FutureSearch Trials of Neurology LP | Austin | Texas | 78731 | United States |
| Todd J. Swick | Houston | Texas | 77063 | United States |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| EVMS Sleep Medicine | Norfolk | Virginia | 23510 | United States |
| American Sleep Medicine | Vienna | Virginia | 22182 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Niagra Clinical Research | Niagra Falls | Ontario | L2E 7H9 | Canada |
| Toronto Sleep Institute | Toronto | Ontario | M4P 1P2 | Canada |
| Toronto Psychiatric Research Foundation | Toronto | Ontario | m5K 2A7 | Canada |
| Pediatric Sleep Research Inc | Toronto | Ontario | M6J 3S3 | Canada |
| CARSM Sleep Laboratory & Clinic | Montreal | Quebec | H4J 1C5 | Canada |
| Unesta Research Center | Tampere | 33200 | Finland |
| University of Turku , Sleep Research Centre | Turku | 20520 | Finland |
| CHU de Dijon | Dijon | 21000 | France |
| Grenoble University Hospital | La Tronche | 38700 | France |
| Hospital Roger Salengro | Lille | 59000 | France |
| Universite Paris 5 Hôtel-Dieu | Paris | 75004 | France |
| Hopital Bichat - Claude Bernard | Paris | 75018 | France |
| CHU de Poitiers | Poitiers | 86000 | France |
| Somnolab Dortmund | Dortmund | 44263 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| Sleep Wake Center SEIN Heemstede | Heemstede | North Holland | 2103 SW | Netherlands |
| Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384. |
| 33179591 | Derived | Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992. |
| 31691827 | Derived | Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220. doi: 10.1093/sleep/zsz220. |
Placebo administered orally, QD, for the 2-week randomized withdrawal period.
| COMPLETED |
|
| NOT COMPLETED |
|
| Randomized Withdrawal Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Period | 643 subjects comprised the safety population. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Epworth Sleepiness Scale (ESS) Score | Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period. | 282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110. | Posted | Least Squares Mean | Standard Error | points on a scale | Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Subjects Reported as Worse on the Patient Global Impression of Change (PGIc) | Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. | 282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110. | Posted | Number | percentage of subjects | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc) | Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. | 282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110. | Posted | Number | percentage of subjects | Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks) |
|
|
The Safety Population consisted of all subjects who received at least 1 dose of study medication. Adverse events are reported across the entire study (e.g., the open-label and randomized withdrawal periods combined).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JZP-110 | Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase. | 1 | 643 | 27 | 643 | 269 | 643 |
| EG001 | Placebo | JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving. | 0 | 142 | 0 | 142 | 3 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Prostate cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Ear canal injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal inflammation | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Disclosure & Transparency | Jazz Pharmaceuticals | 215-970-7145 | ClinicalTrialDisclosure@JazzPharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2016 | Apr 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000623308 | solriamfetol |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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