Benzonatate, Market

The Benzonatate market is witnessing a CAGR of 6% during the forecast period of 2025-2035. Benzonatate is a non-narcotic antitussive drug that was approved by the U.S. Food and Drug Administration (FDA) in 1958 under the trade name Tessalon Perles for symptomatic relief of cough. It works by anesthetizing stretch receptors in the respiratory tract, lungs, and pleura, thus suppressing their activity and lessening the cough reflex at its origin. The drug takes effect within 15 to 20 minutes, with effects lasting 3 to 8 hours

Benzonatate is available as soft gelatin capsules with 100 mg, 150 mg, or 200 mg of active ingredient. Inactive ingredients are D&C Yellow #10, gelatin, glycerin, purified water, methylparaben, and propylparaben. The production process follows strict FDA guidelines to provide a safe and effective product. The FDA’s proposed guidance on benzonatate contains industry recommendations on the development of generic products, with a focus on bioequivalence studies and compliance with current good manufacturing practices. Although it has therapeutic utility, benzonatate has serious safety implications, especially among children.

Fatal overdose has been reported by the FDA in children younger than 10 years following accidental benzonatate capsule ingestion. Overdose symptoms can occur within 15 to 20 minutes and can range from restlessness, tremors, convulsions, coma, and cardiac arrest. Therefore, the FDA advises that benzonatate be packaged in child-resistant containers and kept away from children to avoid accidental ingestion. Health care professionals should advise patients on the correct way to take benzonatate, with proper assurance that capsules should not be chewed or dissolved but should be taken whole. This is because chewing or dissolving the capsules may result in severe hypersensitivity reactions such as bronchospasm, laryngospasm, and cardiovascular collapse. Patients should also be advised on possible side effects and the need to stick to recommended dosages.