Novel Developments in the Pharmacological Management of Insomnia

Advances in the basic science of sleep/wake neurophysiology are driving the exploration of new pharmacologic approaches with continued improvement in efficacy and safety.

A wide range of substances has been used in the attempt to improve sleep. Advances in the basic science of sleep-wake neurophysiology are driving the exploration of new pharmacologic approaches with continued improvement in efficacy and safety. Investigational compounds presently under review with the Food and Drug Administration (FDA) that may be approved for sleep disorder indications include suvorexant and tasimelteon. Safety problems plagued early sedating compounds. The current generation of FDA-approved insomnia medications has been evaluated for safety and efficacy, and detailed prescribing information is available for each drug. FDA-approved medications indicated for the treatment of insomnia include several benzodiazepine receptor agonists (benzodiazepines and nonbenzodiazepines), a single melatonin receptor agonist, and a single histamine H₁ receptor antagonist. Novel alternate delivery formulations of zolpidem are now available, the most recent with an indication for use with middle-of-the-night awakenings.