Daridorexant: A New Dual Orexin Receptor Antagonist for Insomnia.

To review the safety, efficacy, and tolerability of daridorexant in treating insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients. A literature search was performed through PubMed using the following key terms: , and . Selected articles included those which described clinical studies of the pharmacokinetics, efficacy, safety, or tolerability of daridorexant. Daridorexant works through antagonism of the dual orexin receptor. It is the third agent in this class of medications approved by the U.S. Food and Drug Administration (FDA). Daridorexant, at a dose of 25 mg to 50 mg, was shown to be effective in improving sleep parameters in phase 3 clinical studies and was well tolerated. Adverse event rates from phase 2 and 3 clinical trials were low with fatigue, nasopharyngitis, gait disturbance, somnolence, diarrhea, and headache most commonly reported. All currently available agents for treating insomnia have received a "weak" recommendation in the clinical practice guidelines, including the dual orexin receptor antagonist class of medications. Initial data suggest that with routine use daridorexant does not impair next day functioning, a common issue with other agents used to treat insomnia. In addition, daridorexant appears to be as safe and effective in treating insomnia in patients of all ages including those ≥65 years of age.