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summary scores, and SF-36 mental component summary scores than the pla­cebo group.
Safety SXB was well tolerated but patients had statistically more AEs versus pla-
cebo, including nausea (relative risk [RR]: 7.74), vomiting (RR:11.8), and dizziness (RR: 4.3). Enuresis was not signicantly different from placebo [62]. Sleepwalking was reported in 4% of 717 patients treated in clinical trials with SXB [63]. Post­marketing data indicate a very low risk of abuse/misuse of SXB. Serious AEs, reported in ~6% of patients, included depression, angina, and suicide attempt. No acute withdrawal symptoms were observed after 2weeks of discontinuation follow­ing an average of 21months of therapy. The abrupt cessation of SXB did not cause acute rebound in cataplexy [64]. Caution is advised when treating narcoleptics with concurrent SXB, and to ensure adherence to positive pressure therapy before start­ing SXB.The overall safety prole including potential drug interactions of SXB is expected to be similar to lower-sodium oxybate [61].
Synergistic interactions of SXB with alcohol or other CNS depressants may increase the risk of intoxication or overdose. The agents should not be taken in combination with sedative hypnotics or in patients with succinic semialdehyde dehydrogenase deciency. Patients with compromised liver function should have their starting dose decreased by one-half and response to dose increments moni­tored [58]. Most patients can be effectively transitioned from SXB to lower-sodium oxybate without any difculties.
J. H. Dailey and S. Chowdhuri
Summary SXB is used in combination with other therapies to adequately control all symptoms of narcolepsy. A lower-sodium oxybate offers another treatment option for treating cataplexy in patients with narcolepsy and cardiovascular/renal disease or other health condition/valid medical reason requiring a lower daily sodium consumption.
Solriamfetol
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with EDS.Solriamfetol was approved based on two 12-week RCTs, in patients with narcolepsy [65] and OSA [66], respectively. It is not approved for treating cataplexy.
Efcacy Narcolepsy: Treatment of Obstructive Sleep Apnea and Narcolepsy Excessive Sleepiness (TONES 2 and 3) were double-blind randomized, placebo­controlled parallel-group trials. In TONES 2 [65], patients with narcolepsy type 1 or 2 (n = 231) with baseline ESS of ≥10 (mean, 17.2) and a baseline mean SL of <25minutes based on 4-naps MWT were randomized to receive placebo, solriamfetol 75, 150, or 300mg daily. The co-primary endpoints were change from baseline to 12weeks in MWT and ESS. The PGI-C at 12weeks was the key secondary end­point. At week 12, solriamfetol 150 and 300mg signicantly increased the mean
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change of SL versus placebo from baseline on MWT of 7.7 and 10.1 minutes, respectively. Signicant decreases of −2.2, −3.8, and −4.7 in ESS scores were found with solriamfetol 75, 150, and 300mg compared to placebo, respectively. The NNT to achieve an ESS≤10 using solriamfetol 150 and 75mg versus placebo at 12 weeks was calculated to be 4 and 7 in a post-hoc analysis, respectively. Improvements in MWT and EES scores were sustained throughout the trial’s dura­tion. The improvement in PGI-C (Patient Global Impression scale) was dose­dependent and signicant at 150 and 300mg doses versus placebo. However, the recommended doses for patients with narcolepsy are 75 and 150mg once daily. Dosages above 150mg increased dose-related AEs without additional benet. No trials comparing solriamfetol with other agents used for the treatment of EDS are available.
OSA The TONES-3 trial randomized 476 adults with OSA and evaluated the ef-
cacy and safety of solriamfetol 37.5, 75, 150, and 300 mg, with placebo over 12weeks [66]. The participants had a mean baseline ESS score of ~15 and a mean MSL on MWT between 12 and 13minutes. The participants had to either currently use or had prior use of a primary OSA therapy including PAP, mandibular advance­ment device, or surgical intervention. The severity of OSA was not specied. The trial did not specify whether surgery was effective in treating OSA or the required hours of PAP use. At baseline, primary OSA therapy was used by 69.7% of partici­pants on placebo and 73.5% randomized to solriamfetol, of which ~90% were on PAP.The primary OSA therapy nonadherence ranged from 27.1%- 31.6% in the study. The inclusion criteria of baseline ESS score and endpoints were the same as in TONES-2 trial, and the baseline SL for MWT was ≤30minutes.
All solriamfetol doses increased wakefulness signicantly relative to placebo in patients with OSA.The SL mean change from baseline per MWT was 13.0, 11.0,
9.1, 4.7minutes with 300, 150, 75, and 37.5mg at 12weeks, respectively. The dose­dependent effects were sustained over the study duration. All solriamfetol doses resulted in a decrease in sleepiness as indicated by the ESS score compared to pla­cebo at 12weeks. The ESS decrease was dose-dependent and ranged from −3.3 to
−7.9 with solriamfetol 37.5–300mg daily. The key secondary endpoint of PGI-C was met at all doses except for the 37.5mg dose.
In TONES 2, AEs incidence (≥5%) with all doses of solriamfetol included
Safety
headache (21.5%), nausea (10.7%), decreased appetite (10.7%), nasopharyngitis (9%), dry mouth (7.3%), and anxiety (5.1%) [65]. Patients with previous history of headache or migraines had a higher incidence of headache. Of note, blood pressure (BP) taken 9hours post dose showed an increase from baseline in systolic and dia­stolic BP (1–2mmHg) and heart rate (2–4 beats per minutes) for solriamfetol 150 and 300 mg doses compared to placebo. The discontinuation rate was higher in the solriamfetol 300mg group (27.1%), solriamfetol 75mg (16.9%), placebo (10.3%), and solriamfetol 150mg (7.3%). The NNH in TONES 2 for any or all treatment­emergent AEs was 8 and 3 for solriamfetol 75mg and 150mg, respectively, com­pared to placebo at 12weeks.
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In TONES 3, AEs and discontinuations caused by AEs were dose-dependent [66]. The most frequent AEs with solriamfetol occurring ≥5% were similar to what was seen in TONES-2 trial. At week 12, BP was increased compared to baseline with the highest increase noted when 300mg dose was used; 2.5 and
1.5mmHg systolic and diastolic, respectively. Small mean increase in heart rate was also seen with solriamfetol 150 and 300mg doses. Long-term cardiovascular consequences are not available. The dose should be adjusted in patients with renal disease. There is potential for abuse of this drug. It is unknown whether solriamfetol in combination with other medications for the treatment of narco­lepsy is safe and tolerated and whether this therapy can be extrapolated to those that refuse primary OSA therapy.
Summary Solriamfetol is effective in reducing EDS in patients with narcolepsy and OSA treated with PAP, but there is risk for dose-dependent AEs.
J. H. Dailey and S. Chowdhuri
Pitolisant
Pitolisant is indicated for the treatment of EDS or cataplexy in adult patients with narcolepsy. Pitolisant is a histamine-3 (H3) receptor antagonist/inverse agonist that blocks the inhibitory effect of the H3 receptors and increases the synthesis and release of histamine into the brain synapse, so the locus coeruleus NE neurons are activated. The antagonism of the H3 receptors with pitolisant can increase the release of other neurotransmitters such as acetylcholine, norepinephrine, and dopa­mine levels in the prefrontal cortex [67].
Efcacy The efcacy of pitolisant in narcolepsy was established in two 8-week Phase 3 RCT studies involving narcoleptic adults (n=258) with EDS [68, 69]. Randomized patients received pitolisant, placebo, or the active comparator agent, modanil. In the rst RCT (n = 95), 81% of narcoleptics had cataplexy upon entry. Pitolisant 9–36mg/day demonstrated a signicant improvement in EDS assessed by ESS compared to placebo at 8weeks. The treatment effect changes from baseline EES score between pitolisant and placebo was −3.1. The improve­ment in objective test of wakefulness and attention tests with pitolisant versus placebo was conrmed but were not signicantly different with modanil 100–400mg daily. The SL increased 32% with pitolisant and decreased 10% with placebo. Responder rates in the post-hoc analyses (dened as an EES score ≤10) for pitolisant were signicantly greater compared to placebo (45% vs. 13%, respectively) but not compared with modanil. Similarly, for the daily cataplexy rates in the post-hoc analyses, in which 35% of the patients continued their usual anticataleptic drugs (sodium oxybate, (n = 8); or antidepressants, (n = 25)), pitolisant was superior to placebo in decreasing the number of daily cataplexy attacks from baseline assessed by sleep diary entries but was not non-inferior to modanil [68].
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The second RCT (n=164) studied a lower daily dose range of pitolisant of
4.5–17.8mg [69]. The maximum dose was reached by 76% of the patients and ~78% of the patients had cataplexy upon randomization. Pitolisant had a treat­ment effect of −2.12in the ESS score versus placebo after 8weeks but there was no signicant improvement in EDS.Non-inferiority test between pitolisant and modanil 200 or 400mg daily could not be concluded. On the objective tests MWT and SART (sustained attention to response task), pitolisant was signi­cantly greater compared to placebo but not different from modanil. In a post­hoc analyses, responder rate (dened as an ESS score ≤10 or ESS score reduction ≥3), pitolisant was signicantly greater (64%) compared to placebo (35%). No signicant difference between the responder rate for pitolisant and modanil groups was seen and there was no reduction in cataplexy rates compared to pla­cebo at this lower dose [69].
Safety The AEs most frequently reported for pitolisant from pooled studies
(8weeks) versus placebo were headache (18.7% vs. 14.9%), nausea (5.9 vs. 2.7%), and insomnia (5.8% vs. 2.3%). The neuropsychiatric AEs seen were insomnia (8.4%); dizziness (1.4%), depression (1.3%), tremor (1.2%), sleep disorders (1.1%), and vertigo (1.0%) [69].
Pitolisant is contraindicated in patients with Child-Pugh C.Clinically rele­vant interactions are expected with strong CYP2D6 inhibitors and CYP3A4 inducers. Concomitant administration of antihistamine-1 receptor antagonists and sedating antihistamines may impair the efcacy of pitolisant [69] and lower the efcacy of hormonal contraception. Supratherapeutic doses of pitolisant have been associated with QTc interval prolongation and drug monitoring is required in patients with cardiac disease. Pitolisant has no abuse, tolerance, rebound or withdrawal potential and it is not a scheduled controlled substance nor a stimulant.
Summary
Pitolisant is an alternate agent that is not a scheduled controlled sub-
stance, effective in the treatment of EDS and cataplexy in narcolepsy, and to be used with caution in patients with cardiac disease.
Novel Drugs inPipeline
Several drugs for either insomnia or EDS are undergoing clinical trials or have shown promise in animal studies and are awaiting clinical trials. These drugs and their potential site(s) of action are presented in Table2.6 [70].
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Table 2.6
Compound/ NTC number Mechanism of action Target indication
Daridorexant 02839200
Seltorexant 03682380
SKP-1041 00878553
Lorediplon (unknown)
EVT-201 00380003
Esmirtazapine 00631657
LY2624803 000784875
Piromelatine 02615002
Pentetrazol BTD-001 03542851
FT218 02720744
THN102 03624920
Reboxetine (AXS-12) 03881852
TAK-925 03332784
Novel drugs in development [79]
Dual orexin receptor antagonist Insomnia
Selective orexin-2 receptor antagonist Insomnia and related mood
GABA
receptor enhancer-
A
(experimental formulation of zaleplon) GABA
receptor enhancer: (longer
A
acting non-BDZ)
receptor enhancer Sleep initiation and maintenance
GABA
A
Antidepressant Sleep initiation and maintenance,
Histamine H1 receptor serotonin2A (5HT-2A) receptor modulator
NT1/2/3/5-HT1A/D receptor agonist Cognitive and sleep effects in
Non-competitive GABA antagonist
Sodium oxybate ER Long-acting sodium oxybate for
Combination of modanil and ecainide Parkinson’s disease and EDS
A selective norepinephrine reuptake inhibitor
Hypocretin 2 receptor agonist Narcolepsy
receptor
A
disorders (MDD) Insomnia with middle of the night
awakening Insomnia
mental disorders Insomnia
Alzheimer’s disease Narcolepsy
narcolepsy
Narcolepsy and cataplexy
Conclusion
In summary, the drugs promoting sleep and wakefulness have evolved over the years to precisely target the sleep and wake-related neurons and neurotransmitters in the brain. These agents are meant for use in conjunction with non-pharmacologic therapies. Unlike the older pharmacologic agents, the newer medications for these disorders have been studied in well-designed placebo-controlled RCTs, albeit mostly industry-sponsored, with evaluation for efcacy and AEs. Many of the agents reviewed are indicated in adults with limited or ongoing studies in pediatric age groups. Personalized medicine has become increasingly important in effective patient care, and the future of sleep pharmacology rests with developing agents that target specic wake/sleep-promoting receptors, tailored for subpopulations of patients suffering from these disorders.
Acknowledgments Merit Review Award, Department of Veterans Affairs, Grant #1I01CX001938-01.
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J. H. Dailey and S. Chowdhuri
Chapter 3
https://t.me/medicina_free
Sleep Health among Racial/Ethnic groups and Strategies to achieve Sleep Health Equity
AziziA.Seixas, AnthonyQ.Briggs, JuditeBlanc, JesseMoore, AliciaChung, EllitaWilliams, AprilRogers, ArlenerTurner, andGirardinJean-Louis
Keywords Sleep quality · Rapid eye movement · Insomnia · Circadian rhythms ·
Social jetlag · Non-rapid eye movement (NREM) · Sleep architecture · Thyromental angle
Introduction
Relative to Whites, racial/ethnic minorities are more likely to experience a higher burden of poor health, chronic disease, accelerated aging, and premature/excess deaths [1–6]. These health burdens can be attributed to several biological, psycho­social, and environmental factors and mechanisms. Notable biological explanations include, but are not limited to, advanced cell aging, DNA methylation, telomeriza­tion of cells, and multimorbidity [2, 7–14]. However, the pathogenesis of poor health, accelerated aging, and disease burden among racial/ethnic minorities is not solely a biological process; it also occurs epigenetically where chronic exposure to
Azizi A.Seixas (AS) and Anthony Q.Briggs (AB) are co-rst authors.
A. A. Seixas (*) · J. Blanc · A. Turner · G. Jean-Louis University of Miami, Miller School of Medicine, Miami, FL, USA e-mail: azizi.seixas@nyulangone.org; azizi.seixas@nyumc.org
A. Q. Briggs New York University Langone Health, Department of Population Health, New York, NY, USA
New York University Langone Health, Department of Psychiatry, New York, NY, USA J. Moore · A. Chung · E. Williams
New York University Langone Health, Department of Population Health, New York, NY, USA A. Rogers
St. John’s University, New York, NY, USA
M. S. Badr, J. L. Martin (eds.), Essentials of Sleep Medicine, Respiratory Medicine, https://doi.org/10.1007/978-3-030-93739-3_3
47© Springer Nature Switzerland AG 2022