Symptom Severity and Treatment Satisfaction in Patients with Idiopathic Hypersomnia: The Real World Idiopathic Hypersomnia Outcomes Study (ARISE)

Abstract

Idiopathic hypersomnia is a debilitating sleep disorder characterized by excessive daytime sleepiness, sleep inertia, and prolonged sleep duration. The patient burden of idiopathic hypersomnia is poorly understood. The Real World Idiopathic Hypersomnia Outcomes Study (ARISE) evaluated symptoms and treatment effectiveness/satisfaction in participants with idiopathic hypersomnia. Methods: ARISE was a United States-based virtual cross-sectional survey. Participants were adults 21-65 years of age with idiopathic hypersomnia recruited from social media, the Hypersomnia Foundation website, and a patient panel. Self-assessments included the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Treatment Satisfaction Questionnaire for Medication, version II (TSQM-vII), and additional treatment questions. Data were analyzed for all participants and for subgroups with/without long sleep time (LST; ≥11 hours in 24 hours). Results: Of 75 participants enrolled, most were female (81.3%). The mean (SD) age was 34.1 (10.7) years and 49% had LST. Most participants took off-label prescription medications (89.3%) and/or used other measures (93.3%) to manage their symptoms. The mean (SD) ESS score was 14.5 (3.5) and the mean IHSS score was 35.2 (7.6). Treatment satisfaction was low (mean [SD] TSQM-vII score: overall, 61.9 [21.2]; with LST, 57.9 [21.4]; without LST, 66.7 [20.3]), primarily driven by dissatisfaction with treatment effectiveness. The most common classes of prescription medications used were stimulants (61.3%), wake-promoting agents (28.0%), and antidepressants (18.7%); non-prescription measures used to manage symptoms included caffeine (73.3%), planned naps (34.7%), and individual accommodations (32.0%). Conclusion: Overall, participants with idiopathic hypersomnia, with or without LST, had substantial symptom burden despite most of the study population taking off-label medications and using nonprescription measures to manage symptoms.

Impairment in Functioning and Quality of Life in Patients with Idiopathic Hypersomnia: The Real World Idiopathic Hypersomnia Outcomes Study (ARISE)

“…An important point is that these impairments were observed despite most participants (89.3%) taking off-label medications to treat idiopathic hypersomnia, primarily stimulants, wake-promoting agents, and antidepressants. 15 This suggests that off-label treatment options are not sufficient to manage symptoms in most people with idiopathic hypersomnia. Baseline scores for daily functioning and work productivity were similarly low in participants of a Phase 3 trial (of whom 55.8% were taking off-label alerting agents), which further supports the inadequacy of off-label treatment options.…”

“…The ARISE study also assessed symptom severity and treatment effectiveness/satisfaction, which are reported in a separate publication. 15 …”

Long-Term Treatment of Narcolepsy and Idiopathic Hypersomnia with Low-Sodium Oxybate

“…Nonpharmacologic interventions include lifestyle modifications and preventive therapy focusing on factors such as sleep hygiene (eg, discontinuation of electronics use well before bedtime), adjustment of work hours (eg, beginning work later in the day rather than early morning), regular exercise, and a healthy diet. [42][43][44] In addition, cognitive behavioral therapy for hypersomnia emphasizes education about the disease state, self-identity and self-image (including strategies for self-acceptance), structured daytime and nighttime activities, coping skills and emotional regulation, social support, and medical/legal/occupational issues (eg, potential accommodations). 45 As far as pharmacologic approaches, narcolepsy and idiopathic hypersomnia are often treated offlabel, and treatment is generally symptomatic (eg, EDS and cataplexy) due to poor understanding of the pathophysiology of NT2 and idiopathic hypersomnia.…”

Successful Challenge With Brexpiprazole for Idiopathic Hypersomnia in a Patient With Bipolar Disorder: A Case Report

“…It has been reported that individuals with IH experience more anxiety and depression compared to those without IH [ 3 ]. Patients with IH often describe experiencing autonomic symptoms such as headaches, temperature dysregulation, and fainting more frequently as compared to healthy individuals [ 4 ]. Idiopathic hypersomnia can thus negatively affect many aspects of daily life.…”

“…However, the approval of modafinil for IH in Europe was rescinded in 2011 after a re-evaluation found insufficient evidence to support the indication for its use and after reports of rare severe skin reactions [ 7 ]. Unfortunately, most individuals with IH still cannot function well in many areas of their lives [ 4 ].…”