Summary: A combined analysis of survey data and social media conversations from a patient Facebook group and subreddit highlights challenges faced by individuals taking twice-nightly sodium oxybate for narcolepsy. Patients reported frequently missing or improperly timing their second dose, leading to negative effects on sleep quality, daytime functioning, and safety. These findings emphasize the burden of this dosing regimen and suggest the potential benefits of once-nightly treatment options to improve adherence and outcomes.
Key Takeaways:
- Adherence Challenges: Most patients taking twice-nightly sodium oxybate reported missed or improperly timed second doses, negatively affecting sleep quality, daytime alertness, and productivity.
- Safety Concerns: Nearly one-third of patients experienced injuries such as falls or bruises when waking to take the second dose, further highlighting the risks associated with this dosing schedule.
- Need for Alternatives: Patients expressed a preference for once-nightly treatment options, which could reduce the burden, improve safety, and enhance overall management of narcolepsy symptoms.
Avadel Pharmaceuticals plc announced the publication of combined findings from a social media analysis and a survey of people with narcolepsy taking twice-nightly sodium oxybate.
Results showed that these individuals report inconsistent adherence to prescribed dosing, which can lead to negative consequences in their lives. The recommended dosing for twice-nightly sodium oxybates is a first dose at bedtime and a second dose administered 2.5 to 4 hours later.
The paper was published in Brain Sciences.
“These findings clearly illustrate the importance of listening and learning from the lived experience of individuals living with a chronic disease like narcolepsy. Narcolepsy steals away time and predictability in a day, is socially isolating, and carries a high degree of burden, which includes barriers to access of optimal care and treatments. Therefore, some individuals may hesitate to share all aspects of their lived journey with their provider but are more open in social media forums, providing them social support while also exposing critical care gaps and impediments. Social media listening is a valid data science that provides these insights, as well as opportunity to intervene, such as is the case we have seen here with oxybate medications,” says Anne Marie Morse, DO, a board-certified and fellowship-trained pediatric neurologist and sleep medicine specialist at Geisinger, in a release.
She continues, “As sleep clinicians, we have normalized waking up in the middle of the night to take a second dose of oxybate medications because it was the only option for decades. This research is a call to action to re-evaluate our practices and quality of communication. We can best partner with patients by inviting the opportunity to freely communicate challenges, discuss alternatives, and plan together for their next steps. Inconsistent adherence, including missing doses or improper timing between doses, only augments the vulnerability to inconsistencies a person may feel living with narcolepsy and results in sub-optimal management both pharmacologically and psychologically. A single-dose oxybate treatment option should be considered for appropriate people with narcolepsy to decrease the burden, optimize safety and potentially improve a sense of predictability.”
Open-source natural language processing analysis techniques were implemented to identify topics and their prevalence discussed in social media posts and comments sourced from a private Facebook group called “People with Narcolepsy for People with Narcolepsy (PWN4PWN)” and a public subreddit, “r/narcolepsy.”
Data included in the social media listening analysis spanned more than 11 years (August 2011 to October 2022). Conversations discussing twice-nightly sodium oxybate were isolated for analysis.
A survey was then administered to people with narcolepsy to better understand their experiences with oxybate therapy. The survey was fielded to members of PWN4PWN from Oct 12 to Nov 6, 2022. A total of 87 adults aged 18 or older living in the United States participated. The respondents included patients who were currently taking or had previously taken twice-nightly oxybate therapy or caregivers of a person with a narcolepsy diagnosis.
Key findings include:
- The majority of respondents (75.3%) reported accidentally missing their second dose of oxybate therapy, with 37% missing their second dose once a week or more often and 28% missing their second dose once per month.
- As a result of missing their second dose, respondents most frequently reported poor sleep quality, excessive or increased daytime sleepiness, and decreased next-day productivity that affected their next-day functioning.
- Nearly three-fourths of respondents reported improper timing of their second dose, with 58.8% reporting taking their second dose too late (more than 4 hours after the first dose) and 21.2% taking their second dose too early (less than 2.5 hours after the first dose).
- Of those who reported taking their second dose too late, 20% reported doing so once per week or more often and 54% reported doing so once per month.
- Of those who reported taking their second dose too early, 17% reported this happening once per week or more often and 22% reported this occurrence happening once per month.
- The most common effects or issues reported due to taking their second dose late included missing activities, grogginess or difficulty functioning the next day, while taking the second dose earlier than prescribed resulted in fear, anxiety and confusion or disorientation
- Nearly one-third of respondents (31.8%) said they experienced injuries, such as falls, bumps, bruises, or black eyes, after waking to take their second dose. Of these individuals, 14% reported an injury once per week or more often and 19% reported an injury occurred once per month.
- More than three out of four respondents (75.9%) agreed or strongly agreed that a once-nightly dose in a premeasured dosing packet would be safer than twice-nightly oxybate formulations.
“This research confirms what we have consistently heard first-hand from patients and observed in our RESTORE study: There are many challenges associated with chronically waking up to take a dose of oxybate medication in the middle of the night, ranging from completely missed doses, doses taken too late, with next day implications, and/or a dose taken too early, with the potential for CNS depression and associated risks. Once-at bedtime Lumryz obviates these issues,” says Jennifer Gudeman, PharmD, senior vice president of medical and clinical affairs of Avadel, in a release. “Lumryz, in addition to helping improve cataplexy and excessive daytime sleepiness symptoms, alleviates many of the patient-vocalized treatment burdens associated with twice-nightly, first-generation oxybates.”
Lumryz has a boxed warning as a central nervous system depressant and for its potential for abuse and misuse. Lumryz is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the Lumryz REMS.
Lumryz is an extended-release sodium oxybate medication approved by the US Food and Drug Administration on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy. On Oct 16, Lumryz was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in patients 7 years of age and older with narcolepsy.
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