View the Expanded Table: Some Oral Drugs for Chronic Insomnia

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.

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 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.

Patients who receive pretravel advice can reduce their risk for many travel-related conditions. Vaccines recommended for travelers are reviewed in a separate issue.

View the Expanded Table: Some Drugs for Altitude Illness, Jet Lag, and Motion Sickness

Cognitive behavioral therapy for insomnia (CBT-I) is recommended for initial treatment of chronic insomnia. Pharmacologic treatment should be used in addition to CBT-I when CBT-I alone is not effective.

View the Expanded Table: Some Oral Hypnotics for Insomnia

Pharmacological treatment of insomnia includes prescription drugs, non-prescription medications, and "natural" remedies. Behavioral approaches such as cognitive behavioral therapy, which are not discussed here, are also used. Pharmacologic treatment and behavioral therapy are often combined.

Patients planning to travel to other countries often ask for information about prevention of diarrhea, malaria, and other travel-related conditions. Vaccines recommended for travelers based on their destination, length of stay, and planned activities were reviewed in a previous issue.

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.

The FDA has approved the melatonin receptor agonist tasimelteon (Hetlioz – Vanda) for treatment of non-24-hour sleep-wake disorder (non-24), which is common in totally blind persons. Tasimelteon is the first drug approved for this indication and the second melatonin receptor agonist approved for use in the US; ramelteon (Rozerem) was approved earlier for treatment of insomnia. Melatonin itself has not been approved by the FDA for any indication; it is available in the US as a dietary supplement and is promoted as a sleep aid.

Pharmacological treatment of insomnia includes prescription drugs, non-prescription medications and "natural" remedies. Behavioral changes are often needed as well.

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.

The majority of patients with insomnia do not have a predisposing psychiatric disease. Rather, untreated insomnia may be a risk factor for development of psychiatric problems such as depression or anxiety.

Many drugs can cause psychiatric symptoms, but a causal connection is often difficult to establish. Psychiatric symptoms that emerge during drug treatment could also be due to the underlying illness, previously unrecognized psychopathology, or psychosocial factors. The withdrawal of some drugs can cause symptoms such as anxiety, psychosis, delirium, agitation or depression.

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Many drugs are used to treat insomnia, but for some patients nonpharmacological treatments such as changing sleep habits, relaxation training and cognitive therapy may be more effective and durable than treatment with drugs. Hypnotic drugs are generally FDA-approved only for short-term use, but in practice they often are taken much longer.

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.

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.