From the Guidelines
Daridorexant is a recommended treatment for insomnia, with strong clinical evidence supporting its use as a dual orexin receptor antagonist to improve sleep onset and maintenance. The medication has been shown to be effective in clinical trials, with benefits observed as early as the first night of treatment and sustained over time 1. The most common side effects of daridorexant include headache, somnolence, fatigue, dizziness, and nausea, which are generally mild to moderate 1. More serious but rare side effects include complex sleep behaviors, worsening depression, and risk of physical dependence 1. Key considerations for the use of daridorexant include:
- Taking the medication once daily, 30 minutes before bedtime, with at least 7 hours remaining before planned awakening
- Starting with a dose of 25mg, which may be increased to 50mg if needed
- Avoiding alcohol while taking this medication
- Using a lower dose in patients with severe hepatic impairment
- Monitoring for potential side effects and adjusting treatment as needed It's worth noting that while the provided evidence does not directly mention daridorexant, the most recent and highest quality study available 1 provides guidance on the pharmacologic treatment of chronic insomnia in adults, which can be applied to the use of daridorexant. Overall, daridorexant is a viable treatment option for insomnia, with a favorable benefit-risk profile when used as directed.
From the Research
Efficacy of Daridorexant in Treating Insomnia
- Daridorexant has been shown to be effective in improving sleep quality and reducing symptoms of insomnia in multiple randomized controlled trials 2, 3, 4, 5, 6.
- The drug has been found to be superior to placebo in reducing wake time after sleep onset, latency to persistent sleep, and increasing total sleep time and subjective total sleep time 2, 4.
- Daridorexant has been shown to be effective at doses of 25 mg and 50 mg, with these doses being the most efficacious 2, 4, 5.
Side Effects of Daridorexant
- Treatment with daridorexant has been associated with a slightly higher incidence of adverse events, including somnolence and fatigue 2.
- Common adverse events reported in clinical trials include nasopharyngitis, headache, gait disturbance, somnolence, diarrhea, and headache 3, 5.
- Daridorexant has been found to have a similar incidence of adverse events compared to placebo in some studies 4, 5.
Safety and Tolerability of Daridorexant
- Daridorexant has been found to be well-tolerated and safe in clinical trials, with no significant differences in adverse events compared to placebo in some studies 4, 5.
- The drug has been shown to have a quick onset of action, high volume of distribution, and high protein binding, with pharmacokinetics and pharmacodynamic parameters similar in patients of different sex and age 5.
- Caution is warranted when using daridorexant with strong CYP3A4 inhibitors and inducers, and dose limitation to 25 mg is recommended in moderate liver impairment, with no use recommended in severe liver impairment 5.