PURPOSE: To report the efficacy and safety of lower-sodium oxybate (LXB; Xywav®) during the open-label titration and optimization period (OLT) and stable-dose period (SDP) in a clinical study for the treatment of idiopathic hypersomnia. PATIENTS AND METHODS: Data were collected during treatment titration and optimization in a phase 3 randomized withdrawal trial in adults (18-75 years of age) with idiopathic hypersomnia who took LXB treatment (once, twice, or thrice nightly, administered orally) in the OLT (10-14 weeks), followed by the 2-week, open-label SDP. Endpoints included the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Patient Global Impression of Change, Clinical Global Impression of Change, Functional Outcomes of Sleep Questionnaire (FOSQ)-10, and Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP). RESULTS: The safety population included 154 participants; the modified intent-to-treat population comprised 115 participants. During open-label treatment, mean (SD) ESS scores improved (decreased) from 15.7 (3.8) at baseline to 6.1 (4.0) at end of SDP, and IHSS scores improved (decreased) from 31.6 (8.3) to 15.3 (8.5). Improvements were also observed during OLT in each individual IHSS item and in FOSQ-10 and WPAI:SHP scores. Thirty-five (22.7%) participants discontinued during OLT and SDP, 22 (14.3%) due to treatment-emergent adverse events (TEAEs) during OLT and SDP. The most frequent TEAEs in the first 4 weeks were nausea, headache, dizziness, and dry mouth; TEAE incidence decreased throughout OLT and SDP (weeks 1-4, n = 87 [56.5%]; weeks 13-16, n = 39 [31.7%]). CONCLUSION: During open-label treatment with LXB, participants showed clinically meaningful improvements in idiopathic hypersomnia symptoms and in quality of life and functional measures. TEAE incidence declined over LXB titration and optimization.

• Klíčová slova
• excessive daytime sleepiness, hypersomnolence, pharmacotherapy, quality of life,
• Publikační typ
• časopisecké články MeSH

STUDY OBJECTIVES: In some patients, it is difficult to correctly nosologically classify daytime sleepiness. Clinical manifestations may be nonspecific; on the basis of objective measures it is possible to determine the current severity of sleepiness, but they do not always allow accurate diagnosis. It is especially difficult to distinguish between idiopathic hypersomnia (IH) and hypersomnia associated with a psychiatric disorder (PSY). METHODS: To find significant differences between the IH and PSY groups, we included 67 patients (IH, n = 15; PSY, n = 52) in the study, focusing on differences in self-reported symptoms, evaluating current depressive symptoms using the Beck Depression Inventory-II score and personality traits measured by the Temperament and Character Inventory. All of the patients underwent polysomnography, the Multiple Sleep Latency Test, and ad libitum sleep monitoring. RESULTS: The patients with IH showed greater difficulty than those in the PSY group with waking up in the morning (P < .001) and complained of memory (P = .04) and attention deficit (P = .006). They also showed higher total sleep time (P < .001) and sleep efficiency (P = .007) and a shorter mean sleep latency on the Multiple Sleep Latency Test (P < .001). Nevertheless, the IH and PSY groups did not differ in Beck Depression Inventory scores or personality characteristics. CONCLUSIONS: IH is a syndrome in which depression/external life stressors and personality characteristics also play a role. Patients with IH may benefit from the cooperation of sleep specialists with psychotherapists/psychiatrists. CITATION: Bušková J, Novák T, Miletínová E, et al. Self-reported symptoms and objective measures in idiopathic hypersomnia and hypersomnia associated with psychiatric disorders: a prospective cross-sectional study. J Clin Sleep Med. 2022;18(3):713-720.

• Klíčová slova
• depressivity *, hypersomnia associated with psychiatric disorder *, idiopathic hypersomnia *, personality traits *,
• MeSH
• duševní poruchy * komplikace   MeSH
• idiopatická hypersomnie * komplikace   diagnóza   psychologie   MeSH
• lidé MeSH
• narkolepsie * komplikace   MeSH
• poruchy nadměrné spavosti * komplikace   diagnóza   MeSH
• prospektivní studie MeSH
• průřezové studie MeSH
• zpráva o sobě MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

Idiopathic hypersomnia was first described in 1976 under two forms: polysymptomatic, characterized by excessive daytime sleepiness, long and unrefreshing naps, nocturnal sleep of abnormally long duration and signs of sleep drunkenness upon awakening; monosymptomatic, manifested by excessive daytime sleepiness only. Yet, after 45 years, this sleep disorder is still poorly delineated and diagnostic criteria produced by successive International Classifications of Sleep Disorders are far from satisfactory. The first part of this review is a historical account of the successive names and descriptions of idiopathic hypersomnia: monosymptomatic and polysymptomatic idiopathic hypersomnia in 1976; central nervous system idiopathic hypersomnia in 1979; idiopathic hypersomnia in 1990; idiopathic hypersomnia with and without long sleep time in 2005; idiopathic hypersomnia again in 2014; and, within the last few years, the proposal of separating idiopathic hypersomnia into a well-defined subtype, idiopathic hypersomnia with long sleep duration, and a more heterogeneous subtype combining idiopathic hypersomnia without long sleep duration and narcolepsy type 2. The second part is a critical review of both current ICSD-3 diagnostic criteria and clinical features, scales and questionnaires, electrophysiological and circadian control tests, research techniques, currently used to diagnose idiopathic hypersomnia. The third part proposes a diagnostic evaluation of idiopathic hypersomnia, in the absence of biologic markers and of robust electrophysiological diagnostic criteria.

• Klíčová slova
• central disorders of hypersomnolence, idiopathic hypersomnia, idiopathic hypersomnia with long sleep duration, idiopathic hypersomnia with long sleep time, idiopathic hypersomnia without long sleep duration, idiopathic hypersomnia without long sleep time, narcolepsy, narcolepsy type 1 and narcolepsy type 2,
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH