The FDA has required the manufacturer of eszopiclone (Lunesta – Sunovion), a benzodiazepine receptor agonist approved for the treatment of insomnia, to lower the current recommended starting dose to 1 mg for both men and women because a new study found that an evening dose of 3 mg can impair driving skills, memory, and coordination for more than 11 hours.1 Eszopiclone’s half-life is longer than that of any other drug in its class, which includes zolpidem (Ambien, and generics) and zaleplon (Sonata, and generics).All benzodiazepine receptor agonists may impair performance the next morning,...

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.

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.

The FDA has approved a new low-dose formulation of the tricyclic antidepressant doxepin (Silenor – Somaxon) for treatment of insomnia associated with sleep maintenance. The manufacturer claims that this dose retains the hypnotic effect of doxepin, without typical tricyclic adverse effects. Doxepin is available generically in higher-strength capsules and in a liquid formulation.

Ramelteon (Rozerem - Takeda), a melatonin receptor agonist, has been approved by the FDA for treatment of insomnia characterized by difficulty falling asleep. Unlike all other prescription hypnotics, which are classified as schedule IV drugs, ramelteon is not a controlled substance.

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.

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.

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 suvorexant (Belsomra – Merck), the first orexin receptor antagonist to become available in the US, for treatment of sleep-onset and/or sleep-maintenance insomnia.