Zolpidem (Ambien - Searle), an imidazopyridine hypnotic available in Europe for several years, was recently approved by the US Food and Drug Administration for short-term treatment of insomnia.

Zolpidem oral spray (Zolpimist – NovaDel/ECR), a new formulation of the oral hypnotic zolpidem tartrate (Ambien, and others), has been approved by the FDA for short-term treatment of insomnia characterized by difficulty falling asleep.

On January 10, 2013, the FDA issued a news release to announce that it was requiring the manufacturers of the zolpidem-containing products Ambien, Ambien CR, Edluar and Zolpimist, which are all approved for treatment of insomnia, to lower the doses for women and to recommend in their labeling consideration of a lower dose for men. No change will be required in the dose of Intermezzo, a low-dose sublingual formulation of zolpidem for middle-of-the-night awakening, which is already recommended in a lower dose for women.

Edluar (Meda), a new sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem (Ambien, and others), has been approved by the FDA for treatment of insomnia.

The FDA has approved a new low-dose sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem tartrate (Intermezzo – Transcept/Purdue) for treatment of insomnia due to middle-of-the-night awakening. Ambien and other zolpidem formulations available in the US are labeled for use only at bedtime.

Zolpidem (Ambien - Sanofi-Aventis), a nonbenzodiazepine benzodiazepine receptor agonist, is the most frequently prescribed hypnotic in the US. As its patent approaches expiration, its manufacturer has received FDA approval to market an extended-release formulation of the drug, Ambien CR. The pharmacological rationale for doing so is that short-acting hypnotics like zolpidem are more effective at inducing sleep than they are at maintaining it.

Eszopiclone (Lunesta - Sepracor), a benzodiazepine-like drug, has been approved by the FDA for oral treatment of insomnia. It is the S-isomer of zopiclone (Imovane, and others in Canada), which has been available in other countries for almost 20 years. Unlike similar drugs such as zolpidem (Ambien) or zaleplon (Sonata), Lunesta is not being restricted in its labeling to short-term use. Like other hypnotics, eszopiclone is a schedule IV drug.

Zaleplon, a pyrazolopyrimidine hypnotic, was recently approved by the FDA for short-term treatment of insomia. Zaleplon, like zolpidem, is a non-benzodiazepine that binds to benzodiazepine receptors.

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.

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.