This newsletter includes information about the FDA approval of daridorexant 25 mg and 50 mg for the treatment of insomnia in adults.
We also share practical tips for treating alcohol use disorder, key points from a presentation on the pharmacologic management of BPD, and our practical research summaries (Quick Takes).
Daridorexant for Insomnia
On January 10, 2022, the FDA granted daridorexan (Quviviq) approval to treat adults with insomnia. This was based on a robust phase 3 clinical program that demonstrated significant improvement vs placebo. You can read more here.
- What is daridorexant?
- It is a dual orexin receptor antagonist (DORA) that acts on OX1 and OX2.
- How do orexin receptor antagonists work?
- The most prominent effect elicited by orexinergic signaling is the maintenance of wakefulness.
- By blocking the orexin receptor through antagonistic action, the typical wake-promoting actions of the orexin system are reduced, resulting in subsequent sleepiness and longer sustained periods of sleep.
- What is the known efficacy of daridorexant?
- In 2 multicentre, randomized, double-blind, placebo-controlled, parallel-group trials, daridorexant was effective for sleep induction and daytime functioning.
- Daridorexant 50 mg also improved sleep onset and sleep maintenance to a similar extent, increasing the total sleep time by approximately 1 hour.
- The effect size remained stable after 3 months of treatment.
- The highest dose (50 mg) was the most efficacious.
- What are the main advantages of DORAs over sedatives?
- DORAs promote not only NREM sleep but REM sleep as well, unlike GABA-mediating agents.
- There is less risk for falls among vulnerable populations.
- What is the difference between daridorexant and suvorexant?
- Unlike suvorexant, with daridorexant, even at the 50 mg dose, there is an absence of next-morning residual sleepiness.
- What is the recommended dosage?
- 25 mg to 50 mg once per night, taken orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening
- What are the potential side effects?
- The most common adverse reactions were headaches, somnolence, mild dizziness, nausea, and fatigue.
- Is daridorexant already available?
- It is scheduled to be released to the public in May 2022.
What Clinicians Need to Know About Alcohol Use Disorder, With Joji Suzuki, M.D.
In this interview, Dr. Joji Suzuki reviews current evidence and practical insights for the diagnosis and management of alcohol use disorder. He discusses pharmacologic and nonpharmacologic considerations in the management of patients with at-risk drinking and alcohol use disorder. He also shares practical tips for selecting and initiating these treatments.
Interview highlights include the following:
- Psychiatrists should screen for signs of alcohol use disorder as well as at-risk drinking patterns among all patients.
- FDA-indicated treatments for alcohol use disorder include naltrexone, acamprosate, and disulfiram. Selecting which medication to start often depends on the severity of the disorder, patient comorbidities, and patient preference.
Learn more and earn 0.75 CME credits here.
Pharmacologic Management of BPD: Recent Developments
In this presentation, Dr. Paul Links discusses options for the pharmacologic management of borderline personality disorder. He also reviews the evidence for other agents, such as omega-3 fatty acids, oxytocin, and buprenorphine. Finally, he presents the role of good psychiatric management in treating patients with borderline personality disorder and a variety of clinical vignettes explaining how to approach each case.
Good Psychiatric Management for BPD
- The clinical approach from the Handbook of Good Psychiatric Management is that psychotherapy is the primary treatment.
- The Handbook of Good Psychiatric Management recommends that psychopharmacology has a role in caring for BPD patients.
- Drug management can be helpful and is meant to be a collaborative process.
- Evaluate symptoms when starting a medication, avoid polypharmacy, and monitor side effects.
Learn more and earn 0.5 CME credits here.
Quick Takes: Informing Your Practice
The Effects of Antipsychotic Treatment on the Brain of Patients With First-Episode Schizophrenia
- Since a 2011 study that found evidence for antipsychotic-related decreases in brain volume, additional studies—including those using functional MRI and white matter imaging—have not clearly established a causal role for antipsychotics in the observed brain changes over time following first-episode psychosis. Learn more.
Association Between Mood Disorders and Risk of COVID-19 Infection, Hospitalization, and Death
- Pre-existing mood disorders increase the risk of hospitalization and death among people infected with COVID-19. Three “buckets” of reasons for this connection are offered. Learn more.
Listen to or read the full volume, and earn 0.5 CME credits here.
Listen to Our Podcast: Psychopharm Updates
Don’t miss out on the latest updates in psychopharmacology! Each episode of our podcast showcases one of our products on a regular basis: Video lectures, Quick Takes, and Expert Consultations. We update our feed every 5 days.
- Idorsia. (2022, January 10). Idorsia Receives US FDA Approval of QUVIVIQ (Daridorexant) 25 and 50 Mg for the Treatment of Adults with Insomnia. Retrieved from https://www.idorsia.us/documents/us/media-releases/2201_us-fda-approval-quviviq-announcement.pdf.
- Mignot, E., Mayleben, D., Fietze, I., Leger, D., Zammit, G., Bassetti, C. L., Pain, S., Kinter, D. S., & Roth, T. (2022). Safety and efficacy of daridorexant in patients with insomnia disorder: Results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. The Lancet Neurology, 21(2), 125-139.
