The FDA has restricted its Emergency Use Authorization for the adenovirus-based COVID-19 vaccine manufactured by Johnson & Johnson (Janssen) to adults who are unable or unwilling to receive another COVID-19 vaccine. The mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are preferred for all persons without a contraindication.

The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since 2015 for emergency treatment of opioid overdose. Generic formulations of Narcan have also been approved; the manufacturers of these products will be required to switch them to OTC status and amend their labeling accordingly. Kloxxado, an 8-mg naloxone nasal spray, remains available only by prescription.

The amyloid beta-directed monoclonal antibody lecanemab-irmb (Leqembi – Eisai/Biogen) has now been approved by the FDA for once-monthly use for treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia. It was previously approved only for administration once every 2 weeks. Now, lecanemab can be given every 4 weeks after an 18-month initiation phase of biweekly administration.

The FDA has approved a 12.5-mg tablet formulation of the thiazide-like diuretic chlorthalidone (HemiClor – Ingenus) for treatment of hypertension. Chlorthalidone has been available for years in 15-, 25-, and 50-mg tablets (Thalitone, and generics) and in fixed-dose combinations with azilsartan medoxomil (Edarbyclor) and atenolol (Tenoretic, and generics).

The FDA has approved an oral tablet formulation of sodium sulfate, magnesium sulfate, and potassium chloride (Sutab – Braintree) for colon cleansing prior to colonoscopy in adults. A sodium sulfate-based oral solution (Suprep) has been available in the US since 2010. Sutab is the second tablet formulation to be approved for bowel cleansing prior to colonoscopy; a sodium phosphate-based tablet (OsmoPrep) was approved earlier.

The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children ≤24 months old who are at increased risk for severe RSV disease through their second RSV season. Nirsevimab is the first drug to be approved for protection of all infants during their first RSV season.

The FDA has approved lebrikizumab-lbkz (Ebglyss – Lilly), a subcutaneously injected interleukin (IL)-13 antagonist, for treatment of moderate to severe atopic dermatitis that has not been or cannot be adequately treated with topical therapy in patients ≥12 years old (weight ≥40 kg). Lebrikizumab is the third subcutaneously injected human IgG4 monoclonal antibody to be approved in the US for this indication. Tralokinumab (Adbry), another IL-13 antagonist, is also approved for use in patients ≥12 years old, and dupilumab (Dupixent), an IL-4 and IL-13 inhibitor, is approved for...

The Advisory Committee on Immunization Practices (ACIP) recommends use of certain vaccines in adults residing in the US. Routine childhood immunization has reduced the overall incidence of some of these vaccine-preventable diseases, but many adults remain susceptible. Recommendations for vaccination against COVID-19, seasonal influenza, and monkeypox and vaccination of travelers have been reviewed separately.

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.

Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative pathogens. Recommended antibiotic regimens for outpatient treatment of some common respiratory tract infections are listed in Table 1 for adults and Table 2 for children.