Sleep Month in Review: March 2024

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This sleep month in review highlights the 6 top sleep pieces in March, from FDA news, topline data, and pieces exploring how daylight savings and long COVID impact sleep.

Not long into March, the switch to daylight savings took a hit to many people’s energy levels, everyone losing an hour of sleep. Luckily, March was all about sleep awareness, and there was no shortage of sleep data in the clinical space.

This month in review captures the top sleep articles based on analytics, all the way from the dangers the daylight savings transition poses and how long COVID impacts sleep quality to positive data on investigational drugs and an FDA decision on tasimelteon for Insomnia.

FDA Issued a Complete Response Letter for Tasimelton

FDA Rejects sNDA of Tasimelteon for Treating Insomnia

Vanda Pharmaceuticals Inc. announced on March 4 the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for tasimelteon (HETLIOZ) in the treatment of insomnia.

The decision was based on the submission of a phase 3, multicenter, placebo-controlled, 4-week study evaluating 322 patients with primary insomnia. Participants were randomized to receive either 20 or 50 mg of tasimelteon or placebo. Investigators found patients taking 20 mg and 50 mg of tasimelteon fell asleep 22.9 minutes (P < .001) and 25.9 minutes (P < .001) faster, respectively.

Promising Developments in the Pipeline

KP1077 Is Safe, Tolerable for Improving Idiopathic Hypersomnia Symptoms

A phase 2 trial’s topline results supported the safety and tolerability of KP1077 for idiopathic hypersomnia, announced by Zevra Therapeutics on March 26, 2024. Investigators studied KP1077 for idiopathic hypersomnia in a placebo-controlled, double-blind, multicenter trial.

Participants demonstrated clinically meaningful improvement in excessive daytime sleepiness, as well as improvements in the idiopathic Hypersomnia Severity Scale, Sleep Inertia Visual Analog Scale, and Brain Fog Severity Scale. Due to the positive data, Zevra Therapeutics plans on requesting an end-of-phase 2 meeting with the FDA to discuss the phase 3 clinical trial design.

Axsome Therapeutics Announces New SYMPHONY, CRESCENDO Data in Narcolepsy

Although the CRESCENDO revealed patients on current narcolepsy treatments still experience symptoms of cataplexy, excessive daytime sleepiness, cognitive impairment, and anxiety and depression, the SYMPHONY phase 3 trial shows promise of reboxetine (AXS-12) in narcolepsy, Axsome Therapeutics announced on March 25th. SYMPHONY was a multicenter, randomized, double-blind, placebo-controlled trial evaluating reboxetine—a selective norepinephrine reuptake inhibitor and a cortical dopamine modulator—in 90 patients with narcolepsy and cataplexy.

The SYMPHONY trial found reboxetine for narcolepsy achieved the primary endpoint: a significant reduction in weekly cataplexy attacks after week 5 weeks. Reboxetine also significantly decreased excessive daytime sleepiness, concentration, and memory.

Longer-Form Insights into Sleep: Dangers of Daylight Savings Transition and How Long COVID Impacts Sleep

COVID-19 Never Truly Goes Away: Long COVID’s Debilitating Symptoms Uproots Lives

Long COVID is more debilitating than most people realize. A COVID survivor shared her experience with long COVID and how it impacted her daily lifestyle. Like many others with long COVID, she experienced poor sleep quality, took frequent naps, and struggled to fall asleep at night and wake up in the morning.

Sleep experts provided insight into long COVID’s impact on sleep, surmised explanations for why sleep is impacted, and how it can be difficult to diagnose and treat sleep individuals in individuals with long COVID. Although many sectors of health systems dealing with long COVID closed, organizations such as NIH, the Northwestern Medicine Comprehensive COVID Center, and the Long COVID Alliance still support long COVID research.

Daylight Savings Transition Presents More Health Risks Than Modern Benefits

The switch to daylight savings time is not just bothersome but poses health risks and increases mortality rates. Sleep and neurology experts shared how the daylight time savings transitions misaligns the body’s 3 internal clocks bringing social jetlag. For someone who has an unmanaged health issue, losing an hour of sleep can increase the likelihood of having a heart attack the following day. The transition also increases people’s risk of stroke, atrial fibrillation, and hospital admissions.

Additionally, the switch increases traffic fatalities, which can be especially dangerous for children or teens walking to school in the dark. The experts offered ways to make the switch between standard time to daylight savings time more seamless.

New Association Discoveries

Women Experience Sleep Disruptions, Heightened Anger in Days Leading Up to Period

In case you missed the most-viewed article in March, the piece spotlighted a new study finding women face sleep disruptions in the days leading up to a menstrual period, which may provide insight into their heightened anger. The study included women aged 18 – 35 years (mean age: 24 years) with regular periods who were not on hormonal contraception within the past 3 months. The team sought to provide insight into the interplay between menstrual cycles, emotions, sleep, and the impact of hormonal fluctuations.

The primary focus of the study was to assess how subjective and objective sleep influences women’s emotions. The study found the perimenstrual phase can predict anger, but not other emotions, and this phase had greater rates of sleep disruptions than other phases.