European guideline and expert statements on the management of narcolepsy in adults and children

Bassetti, C.; Kallweit, Ulf; Vignatelli, Luca; Plazzi, Giuseppe; Lecendreux, Michel; Baldin, Elisa; Dolenc‐Grošelj, Leja; Jennum, Poul; Khatami, Ramin; Manconi, Mauro; Mayer, Geert; Partinen, Markku; Pollmächer, Thomas; Reading, Paul; Santamaría, Joan; Šonka, Karel; Dauvilliers, Yves; Lammers, Gert Jan

doi:10.1111/jsr.13387

Cited by 62 publications

(61 citation statements)

References 154 publications

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“…Following a systematic literature review performed from July to October 2018, and an updated literature review in July 2020, the task force strongly recommended SXB in adults for the treatment of EDS, cataplexy, and disrupted nighttime sleep, with a weak recommendation for the treatment of sleep paralysis/hypnagogic and hypnopompic hallucinations. 2 In pediatric patients (>6 years of age), SXB was strongly recommended for the treatment of cataplexy and EDS, and given a weak recommendation for the treatment of disrupted nighttime sleep, sleep paralysis, and hypnagogic and hypnopompic hallucinations.…”

Section: Guidelines On Oxybate Use In Patients With Central Disorders...mentioning

confidence: 99%

“…Sodium oxybate (SXB), first developed in the 1960s, is a central nervous system depressant recommended by the American Academy of Sleep Medicine, European guidelines, and expert statements for the treatment of excessive daytime sleepiness (EDS) and cataplexy in narcolepsy. 1 , 2 SXB was first approved to treat cataplexy in patients with narcolepsy in the United States (2002) and in Europe (2006). 3–6 SXB is currently approved in the United States for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy and in Europe for the treatment of narcolepsy with cataplexy in patients 7 years of age and older.…”

Section: Introductionmentioning

confidence: 99%

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Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

Dauvilliers¹,

Bogan²,

Šonka³

et al. 2022

NSS

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Lower-sodium oxybate (LXB) is an oxybate medication approved to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy 7 years of age and older in the United States. LXB was developed as an alternative to sodium oxybate (SXB), because the incidence of cardiovascular comorbidities is higher in patients with narcolepsy and there is an elevated cardiovascular risk associated with high sodium consumption. LXB has a unique formulation of calcium, magnesium, potassium, and sodium ions, containing 92% less sodium than SXB. Whereas the active oxybate moiety is the same for LXB and SXB, their pharmacokinetic profiles are not bioequivalent; therefore, a phase 3 trial in participants with narcolepsy was conducted for LXB. This review summarizes the background on oxybate as a therapeutic agent and its potential mechanism of action on the gamma-aminobutyric acid type B (GABA B ) receptor at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. The rationale leading to the development of LXB as a lower-sodium alternative to SXB and the key efficacy and safety data supporting its approval for both adult and pediatric patients with narcolepsy are also discussed. LXB was approved in August 2021 in the United States for the treatment of idiopathic hypersomnia in adults. Potential future developments in the field of oxybate medications may include novel formulations and expanded indications for other diseases.

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Section: Guidelines On Oxybate Use In Patients With Central Disorders...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

Dauvilliers¹,

Bogan²,

Šonka³

et al. 2022

NSS

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“…For example, patients with narcolepsy often describe sleepiness as ''fatigue'' or ''tiredness'' which may mislead the clinician [45,60]. Furthermore, cataplexy may be absent or can develop some years after the initial onset of daytime sleepiness [14], or daytime sleepiness can be misdiagnosed as a different sleep disorder (e.g., sleep apnea syndrome, sleep deprivation) [4,61]. Even when present, cataplexy may be misdiagnosed as a different neurologic condition (e.g., epilepsy, drop attack) or may be subtle, manifesting as mild facial, head, or limb weakness [20].…”

Section: Confounding Factors In the Diagnosis Of Narcolepsymentioning

confidence: 99%

“…In children, cataplexy can manifest as atonia (in which they drop objects or stumble, or develop ptosis or jaw slackening) or as hyperkinesis (marked by facial twitches or grimacing) [8,20]. Consequently, cataplexy in children may be misdiagnosed as another neuropsychiatric disorder [8], potentially resulting in the use of a pharmacologic treatment that could mask symptoms or even aggravate cataplexy in narcolepsy [46,61].…”

Section: Confounding Factors In the Diagnosis Of Narcolepsymentioning

confidence: 99%

Current Understanding of Narcolepsy 1 and its Comorbidities: What Clinicians Need to Know

2021

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Narcolepsy is a chronic neurologic disorder associated with the dysregulation of the sleep-wake cycle that often leads to a decreased quality of life and results in a considerable health burden. There is often a delay to diagnosis of narcolepsy, mainly due to the lack of recognition of this disorder. One of the main factors hindering the diagnosis of narcolepsy is the association of comorbidities, which include other sleep disorders, psychiatric disorders, cardiovascular disorders, and metabolic disorders. The signs and symptoms of these comorbidities often overlap with those of narcolepsy, and some of the medications used for their treatment may obscure the symptoms of narcolepsy, leading to a delay in diagnosis. This review is targeted to clinicians unaccustomed to working with sleep disorders and aims to increase recognition and improve the management of narcolepsy.

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“…3,4 Therapeutic guidelines for EDS and cataplexy have been recently updated. [5][6][7] Stimulants such as methylphenidate and amphetamines are second-line drugs for EDS in narcolepsy, because of their sympathomimetic side effects, rebound hypersomnia, abuse potential and tolerance. 2,8 Most of these drugs, such as sodium oxybate, solriamfetol, and modafinil, have a psychostimulant component that is related, at least in part, to their ability to promote dopamine (DA) and norepinephrine (NE) neurotransmission, [9][10][11] either due to inhibition of the reuptake (and/or enhanced transporter internalization or transport reversal) of DA and NE and/or stimulation of their neuronal release.…”

Section: Introductionmentioning

confidence: 99%

Pitolisant, a wake‐promoting agent devoid of psychostimulant properties: Preclinical comparison with amphetamine, modafinil, and solriamfetol

Krief

Berrebi-Bertrand

Nagmar

et al. 2021

Pharmacology Res & Perspec

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Several therapeutic options are currently available to treat excessive daytime sleepiness (EDS) in patients suffering from narcolepsy or obstructive sleep apnea. However, there are no comparisons between the various wake‐promoting agents in terms of mechanism of action, efficacy, or safety. The goal of this study was to compare amphetamine, modafinil, solriamfetol, and pitolisant at their known primary pharmacological targets, histamine H3 receptors (H3R), dopamine, norepinephrine, and serotonin transporters, and in various in vivo preclinical models in relation to neurochemistry, locomotion, behavioral sensitization, and food intake. Results confirmed that the primary pharmacological effect of amphetamine, modafinil, and solriamfetol was to increase central dopamine neurotransmission, in part by inhibiting its transporter. Furthermore, solriamfetol increased levels of extracellular dopamine in the nucleus accumbens, and decreased the 3,4‐dihydroxyphenyl acetic acid (DOPAC)/DA ratio in the striatum, as reported for modafinil and amphetamine. All these compounds produced hyperlocomotion, behavioral sensitization, and hypophagia, which are common features of psychostimulants and of compounds with abuse potential. In contrast, pitolisant, a selective and potent H3R antagonist/inverse agonist that promotes wakefulness, had no effect on striatal dopamine, locomotion, or food intake. In addition, pitolisant, devoid of behavioral sensitization by itself, attenuated the hyperlocomotion induced by either modafinil or solriamfetol. Therefore, pitolisant presents biochemical, neurochemical, and behavioral profiles different from those of amphetamine and other psychostimulants such as modafinil or solriamfetol. In conclusion, pitolisant is a differentiated therapeutic option, when compared with psychostimulants, for the treatment of EDS, as this agent does not show any amphetamine‐like properties within in vivo preclinical models.

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European guideline and expert statements on the management of narcolepsy in adults and children

Abstract: Bassetti and Kallweit shared first authorship. Dauvilliers and Lammers shared last authorship. Bassetti, Kallweit, Dauvilliers and Lammers contributed equally.

Cited by 62 publications

References 154 publications

Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

Current Understanding of Narcolepsy 1 and its Comorbidities: What Clinicians Need to Know

Pitolisant, a wake‐promoting agent devoid of psychostimulant properties: Preclinical comparison with amphetamine, modafinil, and solriamfetol

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