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Novel Developments in the Pharmacological Management of Insomnia
David N. Neubauer, M.D.
FOCUS 2014;12:38-44. doi:10.1176/appi.focus.12.1.38
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Author Information and CME Disclosure

David N. Neubauer, M.D., Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD

Dr. Neubauer reports no financial relationships with commercial interests.

Address correspondence to David N. Neubauer, M.D., Johns Hopkins Bayview Medical Center, 4940 Eastern Ave., Box 151, Baltimore, MD 21224; e-mail: neubauer@jhmi.edu


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.

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Table 1.FDA-Approved Insomnia Treatment Medications
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Table 2.Indications and Side Effects of FDA-Approved Insomnia Treatment Medications


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CME Activity

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Sample questions:
Changes in the diagnostic formulation of insomnia in DSM-5 include which of the following:

See Doghramji: Table 1. DSM-5 Criteria for Insomnia Disorder p 6
The risk of insomnia is greatest in which of the following populations:

See Doghramji: Prevalence, p 3
A 75-year old woman requests a psychiatric consultation for frequently interrupted sleep; she falls asleep readily but awakens about six times per night, getting only about 6 hours of sleep between her bedtime of 11 p.m. and rising at 8 a.m. She is apparently in good health but is fatigued and very worried about getting inadequate sleep. A sleep laboratory study revealed no sleep disorder requiring medical management. Which of the following is the first best treatment choice?

See Byrne: Behavioral Strategies of CBT-I, Sleep Restriction Treatment p 35
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