The following is a summary of “A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder,” published in the April 2024 issue of Psychiatry by Parmenter et al.
People with post-traumatic stress disorder (PTSD) often find themselves with their sleep cycle disturbed. That is where TNX-102 SL might help, as it is a sublingual formulation of cyclobenzaprine and M1 muscarinic receptors, which play roles in the pharmacological management of sleep disturbances.
Researchers conducted a prospective study verifying if this drug could make a real difference and improve sleep and PTSD severity in people with military-related PTSD.
They used different scales to measure sleep and PTSD severity in patients with military-related PTSD—the overall time since the trauma affected the response to the treatment.
The results showed that TNX-102 SL showed promise in improving sleep quality early on. However, it did not make a significant difference in overall PTSD severity compared to the placebo at week 12. The early improvements were associated with TNX_102 SL treatment using the PROMIS sleep disturbance scale and the clinician-identifier PTSD scale (CAPS-5), although the results for week 12 were similar. However, it helped some patients feel better overall by week 4. Moreover, those who had experienced trauma more recently (≤ 9 years) seemed to respond better to the treatment.
Investigators concluded that SL might be a safer option for patients with PTSD symptoms, especially by improving sleep. It is a promising start, but more research is needed to understand its effectiveness fully.
Source: sciencedirect.com/science/article/pii/S0165178124000490
