Abstract Details

Title Effects of Pitolisant on Nighttime Sleep

Topic Sleep

Presentation(s) P3 - Poster Session 3 (12:00 PM-1:00 PM)

Poster/Presentation
Number 5-001

Objective To evaluate effects of pitolisant on nighttime sleep in patients with narcolepsy.

Background Pitolisant, a selective histamine 3 (H₃)-receptor antagonist/inverse agonist, reduces excessive daytime sleepiness and attacks of cataplexy in patients with narcolepsy. Potential side effects of pitolisant treatment include insomnia.

Design/Methods Data collected at a clinical sleep medicine center included both objective (overnight polysomnography [PSG]) and subjective (Pittsburgh Sleep Quality Index [PSQI]) measures of nighttime sleep. Overnight PSG was conducted in accordance with clinical practice guidelines. The PSQI global score ranges from 0 to 21; scores ≥5 indicate poor sleep quality.

Results The sleep center database included 15 patients with narcolepsy who were treated with pitolisant as monotherapy and underwent both baseline and on-treatment PSG. For follow-up PSG, patients were on a stable dosage for at least 3 months. This sample of patients was 60.0% female and had a mean age of 33.9 years; 60.0% of patients were diagnosed with narcolepsy type 1. Patients received pitolisant 35.6 mg/day (60.0%), 26.7 mg/d (13.3%), or 17.8 mg/d (26.7%) for 6 to 12 months. The mean duration of treatment was 10.5 months. The on-treatment means were similar to baseline means for PSG-recorded total sleep time (361.5 minutes and 362.5 minutes), sleep efficiency (78.8% and 79.7%), and arousal index (18.7 and 17.7). There were no significant differences between baseline and on-treatment PSG assessments in the amount of slow wave sleep (17% vs 15%) or REM sleep (19% vs 18.5%). On the PSQI, there was generally no change (global score mean: baseline, 8.9; on-treatment, 9.1), except for the sleep efficiency component (mean score: baseline, 1.2; on-treatment, 1.6; P<0.05). Study limitations include small sample size.

Conclusions This analysis of real-world clinical data suggests that there are no meaningful changes in sleep architecture or sleep quality in patients treated with pitolisant. Additional research is needed to confirm these findings.

Authors/Disclosures
Michael J. Thorpy, MD (Montefiore Medical Center) PRESENTER	Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avadel. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for alkermes. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Harmony. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for centessa. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Thorpy has received publishing royalties from a publication relating to health care.
	No disclosure on file
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Ulf Kallweit	No disclosure on file

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