carbamates has been researched along with Sleepiness in 6 studies
Sleepiness: Compelling urge to sleep.
Excerpt | Relevance | Reference |
---|---|---|
" Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4." | 2.94 | 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. ( Ahmed, M; Baladi, M; Chandler, P; Foldvary-Schaefer, N; Hedner, J; Lee, L; Malhotra, A; Mayer, G; Pepin, JL; Sarmiento, K; Schwab, R; Shapiro, C; Strollo, PJ, 2020) |
"Excessive sleepiness (ES) is a common symptom of OSA, which often persists despite primary OSA therapy." | 2.90 | Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. ( Black, J; Carter, LP; Chen, D; Collop, N; Hedner, J; Lee, L; Lorch, DG; Lu, Y; Pépin, JL; Redline, S; Strollo, PJ, 2019) |
" The proportion of patients with at least one adverse event was significantly increased in solriamfetol group (RR = 1." | 2.72 | Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. ( Chen, G; Gao, H; Li, X; Wang, J; Wang, T; Xu, X; Xu, Z; Yang, S, 2021) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 3 (50.00) | 24.3611 |
2020's | 3 (50.00) | 2.80 |
Authors | Studies |
---|---|
Malhotra, A | 1 |
Shapiro, C | 2 |
Pepin, JL | 2 |
Hedner, J | 2 |
Ahmed, M | 1 |
Foldvary-Schaefer, N | 1 |
Strollo, PJ | 2 |
Mayer, G | 2 |
Sarmiento, K | 1 |
Baladi, M | 1 |
Chandler, P | 1 |
Lee, L | 2 |
Schwab, R | 1 |
Powell, J | 1 |
Piszczatoski, C | 1 |
Garland, S | 1 |
Wang, J | 1 |
Yang, S | 1 |
Li, X | 1 |
Wang, T | 1 |
Xu, Z | 1 |
Xu, X | 1 |
Gao, H | 1 |
Chen, G | 1 |
Collop, N | 1 |
Lorch, DG | 1 |
Chen, D | 2 |
Carter, LP | 2 |
Lu, Y | 2 |
Black, J | 2 |
Redline, S | 1 |
Thorpy, MJ | 1 |
Corser, BC | 1 |
Emsellem, H | 1 |
Plazzi, G | 1 |
Wang, H | 1 |
Dauvilliers, Y | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea[NCT02348632] | Phase 3 | 645 participants (Actual) | Interventional | 2015-05-31 | Completed | ||
A Double-Blind, Randomized, Placebo-Controlled, Single-Center, Flexible Titration Study Evaluating the Efficacy of Solriamfetol in Treating Fatigue and Cognitive Symptoms in Adults Aged 18-65 Years With a Diagnosis of Myalgic Encephalomyelitis/Chronic Fat[NCT04622293] | Phase 4 | 44 participants (Anticipated) | Interventional | 2021-04-27 | Recruiting | ||
A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep A[NCT02348619] | Phase 3 | 174 participants (Actual) | Interventional | 2015-05-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"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." (NCT02348632)
Timeframe: Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)
Intervention | points on a scale (Least Squares Mean) |
---|---|
JZP-110 | 1.6 |
Placebo | 5.3 |
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. (NCT02348632)
Timeframe: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
Intervention | percentage of subjects (Number) |
---|---|
JZP-110 | 28.7 |
Placebo | 63.8 |
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. (NCT02348632)
Timeframe: Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)
Intervention | percentage of subjects (Number) |
---|---|
JZP-110 | 28.2 |
Placebo | 64.5 |
Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities. (NCT02348619)
Timeframe: Week 4 to Week 6
Intervention | units on a scale (Least Squares Mean) |
---|---|
JZP-110 | -0.15 |
Placebo | -1.31 |
"Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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. The response variable was the change in ESS score from week 4 to week 6." (NCT02348619)
Timeframe: Week 4 to Week 6
Intervention | points on a scale (Least Squares Mean) |
---|---|
JZP-110 | -0.1 |
Placebo | 4.5 |
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements. (NCT02348619)
Timeframe: Week 4 to Week 6
Intervention | minutes (Least Squares Mean) |
---|---|
JZP-110 | -0.96 |
Placebo | -12.11 |
Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348619)
Timeframe: Week 4 to Week 6
Intervention | percentage of subjects (Number) |
---|---|
JZP-110 | 22 |
Placebo | 59 |
Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse. (NCT02348619)
Timeframe: Week 4 to Week 6
Intervention | percentage of subjects (Number) |
---|---|
JZP-110 | 20 |
Placebo | 50 |
3 reviews available for carbamates and Sleepiness
Article | Year |
---|---|
Solriamfetol (Sunosi) for excessive daytime sleepiness.
Topics: Adrenergic Uptake Inhibitors; Carbamates; Dopamine Uptake Inhibitors; Humans; Phenylalanine; Randomi | 2019 |
Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea.
Topics: Carbamates; Clinical Trials as Topic; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenyla | 2020 |
Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials.
Topics: Adult; Carbamates; Disorders of Excessive Somnolence; Humans; Narcolepsy; Phenylalanine; Randomized | 2021 |
3 trials available for carbamates and Sleepiness
Article | Year |
---|---|
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.
Topics: Carbamates; Disorders of Excessive Somnolence; Double-Blind Method; Humans; Narcolepsy; Phenylalanin | 2020 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study.
Topics: Adult; Aged; Carbamates; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Mi | 2019 |
A randomized study of solriamfetol for excessive sleepiness in narcolepsy.
Topics: Adult; Carbamates; Double-Blind Method; Female; Humans; Male; Middle Aged; Narcolepsy; Phenylalanine | 2019 |