Nonbenzodiazepine Hypnotic Use and Cases of “Sleep Driving”
Authors: Mary Ross Southworth
Journal: Annals of Internal Medicine (2008)

Letters18 March 2008Nonbenzodiazepine Hypnotic Use and Cases of “Sleep Driving”Mary Ross Southworth, PharmD, Cindy Kortepeter, PharmD, and Alice Hughes, MDMary Ross Southworth, PharmDFrom U.S. Food and Drug Administration, Silver Spring, MD 20993.Search for more papers by this author, Cindy Kortepeter, PharmDFrom U.S. Food and Drug Administration, Silver Spring, MD 20993.Search for more papers by this author, and Alice Hughes, MDFrom U.S. Food and Drug Administration, Silver Spring, MD 20993.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-148-6-200803180-00026 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: “Sleep driving” is a complex, sleep-related behavior described as rising out of bed and driving a vehicle while not fully awake or during an apparent state of sleep, often with no memory of the event afterward. This phenomenon has been reported rarely in the literature (1, 2) and in conjunction with other somnambulistic behavior, such as homicidal somnambulism and nocturnal violence.Objective: To summarize cases of sleep driving associated with the use of the nonbenzodiazepine hypnotics reported to the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System.Methods: On 1 March 2006, we searched the FDA Adverse Events Reporting System for postmarketing reports of sleep driving associated with zolpidem, zaleplon, and eszopiclone by using the following related terms: abnormal sleep-related event, automatism, impaired driving ability, parasomnia, road traffic accident, sleep talking, and sleep walking. We evaluated each identified case to ensure that it met the general requirements for sleep driving, namely, that details of the case implied that the patient, intending to go to sleep, ingested the drug, went to bed, arose, and then drove while partially awake or in an apparent state of sleep. We excluded cases that involved driving while under the influence of the drug but that were not clearly sleep driving (often these cases involved abuse or misuse of the drug or did not report the time between drug ingestion and the event).Findings: We identified 14 cases of sleep driving, 13 of which involved zolpidem. Details of the cases are in the Table. Of the 13 cases, 8 involved concomitant use of a central nervous system (CNS)–active agent (benzodiazepine, alcohol, or narcotic).Table. Characteristics of Sleep-Driving Cases Associated with Zolpidem and ZaleplonDiscussion: Zolpidem was most often implicated in sleep driving, but whether this observation is attributable to a greater risk for sleep driving with zolpidem, more widespread use of the drug, or other factors is unclear. Eight of the cases reported concomitant use of a CNS-active agent, which could have potentiated the effect of the hypnotic. We are unaware of reports of sleep driving occurring with the use of alcohol or other CNS-active medications without concomitant hypnotic use. In 3 cases, the hypnotic was the only drug ingested before the sleep-driving event. No risk factors for sleep driving were apparent other than concomitant use of alcohol or sedating drugs. The cases did not provide information about the individual's history of somnambulism or past exposure to hypnotics.Our analysis of these cases has resulted in the addition of a new warning and Medication Guide to the labeling for all drugs approved for treatment of insomnia (3). Although sleep-driving events may not be predictable, certain precautions and educational measures could be taken to decrease their occurrence. Patients should be warned to avoid concomitant use of CNS-depressant drugs and alcohol.Conclusion: Use of nonbenzodiazepine hypnotics, most notably zolpidem and zaleplon, may be associated with sleep driving, especially when taken in combination with benzodiazepines, alcohol, or narcotics.Mary Ross Southworth, PharmDCindy Kortepeter, PharmDAlice Hughes, MDU.S. Food and Drug AdministrationSilver Spring, MD 20993References1. Broughton R, Billings R, Cartwright R, Doucette D, Edmeads J, Edwardh M, et al. Homicidal somnambulism: a case report. Sleep. 1994;17:253-64. [PMID: 7939126] MedlineGoogle Scholar2. Schenck CH, Mahowald MW. A polysomnographically documented case of adult somnambulism with long-distance automobile driving and frequent nocturnal violence: parasomnia with continuing danger as a noninsane automatism? Sleep. 1995;18:765-72. [PMID: 8638069] CrossrefMedlineGoogle Scholar3. FDA requests label change for all sleep disorder drug products [press release]. Silver Spring, MD: U.S. Food and Drug Administration; 14 March 2007. Accessed at www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html on 18 April 2007. Google Scholar Comments0 CommentsSign In to Submit A Comment Author, Article, and Disclosure InformationAffiliations: From U.S. Food and Drug Administration, Silver Spring, MD 20993.Disclosures: None disclosed. 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