Instructions for Participation and Credit Palo Alto, CA: Jazz Pharmaceuticals, Inc April 2015. European Handbook of Neurological Management. Billiard M, Dauvilliers Y, Dolenc-Grošelj L, et al.Rochester, MN: American Academy of Sleep Medicine 2014. The International Classification of Sleep Disorders-Revised: Diagnostic and Coding Manual.ģrd ed. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. National Institute of Neurological Disorders and Stroke.Non-pharmacological approaches to the treatment of narcolepsy. Parameters for the treatment of narcolepsy and other hypersomnias of central origin. Morgenthaler TI, Kapur VK, Brown T, et al Standards of Practice Committee of the American Academy of Sleep Medicine.Long-term follow-up on the effects of sodium oxybae on daytime sleepiness and sleep architecture in patients with narcolepsy type 1. Adrados MRP, Bellon JM, Triguero LL, Lopez-Esteban P, Medrano-Martinez P. Another limitation was that some of the changes observed between the interval of diagnosis and successive follow-ups with sodium oxybate treatment may have been due to aging and the disease progression. Main limitations of the study included the fact that there were a small number of patients who continued treatment for the total 3 years. Most patients complained about the 2 nightly doses, with mild AEs of dizziness, enuresis, unpleasant feeling of coldness after the first dose, and unintentional weight loss in female non-obese patients common in the first 3 months of treatment, were all observed. Aside from comorbidities and AEs, the reasons for withdrawal included pregnancy (n = 1) and insufficient compliance. Sleep fragmentation in the third part of the night was found to be “very unpleasant” by all patients from FU-1 onwards, and was independent of the second dose administered. Comorbidities and adverse events, which accounted for 3 discontinuations, included 1 case of unspecified psychosis that occurred after the initiation of sodium oxybate in a patient treated with 200 mg of modafinil, 1 case of hypertension, and 1 case of depression. A total of 13 (56.5%) patients discontinued the therapy throughout the trial however, none of these patients showed rebound cataplexy. Treatment with the therapy was associated with an increase in periodic leg movements index, as shown by higher scores at FU-2 ( z = –2.52 P =. READ MORE: Driving Performance in Patients With Narcolepsy Improved Through Solriamfetol Additionally, the apnea-hypopnea index was significantly higher at the last follow-up ( z = –2.66 P = 0). ![]() While there was no significant differences in body mass index in subsequent follow-ups, apnea hypopnea index increased significantly in obese patients. Throughout the trial, in terms of sleep disorder comorbidities, 2 patients developed REM sleep behavior disorder while on 4.5 g/day of sodium oxybate and in another patient who appeared de novo at the same dose. ![]() Furthermore the time spent in stages N1 and N2 were significantly longer in the latest follow-up than at FU-1 ( z = –2.36 P =. At FU-3, there was a significant increased observed in the time spent in stage N1 ( z = –2.09 P =. When comparing the time spent in the different sleep stages between FU-1 and FU-2, patients increased the time spent in stage N2 ( z = –2.17 P =. Additionally, patients were analyzed on stages N1, N2, N3, and REM, as well as total number of awakenings/hour, and apnea-hypopnea and periodic leg movements indexes.įindings on video polysomnography showed an increase in stage N3 in the first sleep cycle and a REM-onset in 90% of patients after the administration of the first dose. Senior investigator Maria Rosa Periata-Adrados, MD, PhD, head of the Sleep & Epilepsy Unit at the University General Hospital Gregorio Maranon, and colleagues performed a standard video-polysomnography at the follow-up time points to analyze several parameters, including sleep efficiency index, sleep latency, REM latency, and wakefulness after sleep onset. The trial featured 23 adults with NT1 who were treated with an initial nocturnal dose of 4.5 g of sodium oxybate, with sleep parameters compared after 6 months (FU-1), 1 year (FU-2), and 3 years (FU-3) of uninterrupted treatment. To the study authors knowledge, this was the longest recorded trial evaluating the effect of sodium oxybate on sleep architecture and comorbidity with video-polysomnography. Findings from a small-scale, longitudinal study assessing patients with narcolepsy with cataplexy (NT1) showed that after 3 years of treatment with low to medium doses of sodium oxybate, there were significant differences in sleep structure and an increase in comorbidities that led to drug withdrawal.
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