The FDA has approved remimazolam (Byfavo – Acacia Pharma), an ultra-short-acting IV benzodiazepine, for induction and maintenance of sedation in adults undergoing procedures of up to 30 minutes' duration.

The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.

Caplacizumab-yhdp (Cablivi – Sanofi /Genzyme), a von Willebrand factor-directed antibody fragment, has been approved by the FDA for use in combination with plasma exchange and immunosuppressive therapy for treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP; formerly called acquired thrombotic thrombocytopenic purpura [aTTP]) in adults. It is the first drug to be approved in the US for this indication.

The FDA has approved insulin lispro-aabc (Lyumjev – Lilly), a faster-acting formulation of insulin lispro (Humalog), for treatment of type 1 and type 2 diabetes in adults. Fiasp, a faster-acting formulation of insulin aspart (Novolog), was approved in 2017.

The opioid agonist tramadol is now available in an oral solution (Qdolo – Athena Bioscience) for management of pain severe enough to require an opioid and for which alternative treatment options are inadequate. Tramadol has been available for years in immediate-release tablets and capsules, extended-release capsules (Ultram, and others), and in a fixed-dose combination tablet with acetaminophen (Ultracet, and generics).

View the Expanded Table: Some Oral Drugs for Chronic Insomnia

The FDA has approved lemborexant (Dayvigo – Eisai), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. It is the second orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) was the first.

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

The FDA has approved the intravenously administered beta₁-adrenergic blocker landiolol (Rapiblyk – AOP) for short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Esmolol (Brevibloc, and generics), another IV beta blocker, was approved earlier for the same indication.

Cognitive behavioral therapy for insomnia (CBT-I) is recommended for initial treatment of chronic insomnia. CBT-I includes stimulus control, sleep education and hygiene, sleep restriction, relaxation training, and cognitive therapy. When CBT-I alone is not effective, pharmacologic treatment should be added.