Written by attorney Grant Ian Schwarz


Ambien, Lunesta Sleeping Medication and DUI

FloridaAmbien DUI Defense Attorney Grant Schwarz

Prescription Sleep Aids Like Ambien Can Cause Unintended Side-Effects

Ambien (Generic: Zolpedim) and Lunesta (Generic: Eszopiclone) are some of the most widely used prescription sleep aids in the United States. Unfortunately, even when used as prescribed, there can be some unintended side effects. One of the most and dangerous side effects is known as Sleep Driving. Sleep Driving is a term coined by the FDA (Food and Drug Administration) to describe the act of driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event

Sleep Driving has become a very prominent issue in cases involving DUI arrests nationwide. Ambien and other prescription sleep aids have also been connected to other complex behaviors such as eating, internet shopping, television shopping, phone calls, cooking and cleaning while under the influence of the drug. People engaging in these behaviors usually have no recollection of anything they may have done while under the influence of the medication.

Ambien and “Sleep Driving"

Sleep-driving occurs as a result of ingesting a sedative-hypnotic product like Ambien or Lunesta. The driver is not fully awake nor fully asleep while driving and will likely have no memory of what they did or said while still feeling the effects of the medication. Reports have shown that sleep-driving may involve extremely impaired driving. Examples of such unusual driving actions are; Crashing into parked cars, entering a fast food drive through, parking the car in unlikely locations, driving on the wrong side of the road, getting lost in one’s own neighborhood and even remaining in the car while running but not moving. Many incidents arise when a police officer responds to the scene of an accident, and the driver has no idea what had happened or that they were even just driving a motor vehicle.

Most incidents involving sleep-driving appear when:

  • Taking a dose of medication and not going directly to bed (continuing to watch television, work, read or do anything else while “waiting" for the medication to take effect)
  • Taking a higher than recommended dosage of Ambien;
  • Combining it with any amount of alcohol;
  • Waking the individual before having a full nights sleep.

The FDA Says Drivers Using Sleep Medications May Not Be At Fault

In March, 2007, the U.S. Food and Drug Administration (FDA) advised producers of sedative-hypnotic drugs (drugs that help with sleep disorders) to modify their warning labels to strongly emphasize the possible risks related to such medications. Drug manufacturers were told to include labels that expressly warned of sleep-driving, allergic reactions, and unusual behavior.




FOR IMMEDIATE RELEASE P07-45 March 14, 2007

Media Inquiries: Sandy Walsh and Kimberly Rawlings, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Requests Label Change for All Sleep Disorder Drug Products

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. “However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

  • Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
  • Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

  • Ambien/Ambien CR (Sanofi Aventis)
  • Butisol Sodium (Medpointe Pharm HLC)
  • Carbrital (Parke-Davis)
  • Dalmane (Valeant Pharm)
  • Doral (Questcor Pharms)
  • Halcion (Pharmacia & Upjohn)
  • Lunesta (Sepracor)
  • Placidyl (Abbott)
  • Prosom (Abbott)
  • Restoril (Tyco Healthcare)
  • Rozerem (Takeda)
  • Seconal (Lilly)
  • Sonata (King Pharmaceuticals)

Ambien has the most reports of sleep driving, however the FDA has issued advisories for other prescriptions as well. Below is a list of other mediation where the FDA has issued warnings for similar effects as Ambien.

DUI & Sleep Medications – Can you be convicted of DUI?

In order to achieve a conviction for DUI, the State must present evidence to prove that you were driving or in actual physical control of a vehicle and that you were under the influence of alcohol or a controlled substance. The State will introduce evidence in the form of a toxicology report conducted through a urine or blood sample collected from you at the time of your arrest. The tests are conducted to show the presence of alcohol, narcotics or other controlled substances. Ambien, however is not classified by the FDA as a controlled substance. This is where your defense may be the strongest. Since Ambien is not considered a controlled substance, the State may not be able to meet their burden of proof, resulting in a dismissal or reduction of charges.



Some frequent questions you will be asked by DUI DEFENSE ATTORNEY will be:

  1. Did you have a valid prescription for your sleep medication?
  2. Did you take the medication in accordance with the instructions given by your prescribing physician.
  3. Was the arresting officer made aware that you had taken the medication?
  4. Is there any evidence to suggest you took more than the recommended dosage?
  5. How many hours after taking the medication were you driving?
  6. Do you have any recollection of driving or being arrested?
  7. Was there evidence that you had also consumed alcohol?
  8. Did you provide a urine sample in connection with your arrest?
  9. Did the police take a blood sample?
  10. Was the blood sample taken with your consent?
  11. Did you provide a breath sample?
  12. What was the result?
  13. Did you submit to field sobriety exercises (Roadside Tests)?
  14. Was the officer who administered the field sobriety tests a properly trained Drug Recognition Expert (DRE)?
  15. Was a toxicology screen performed in your case?
  16. Were prescription drugs tested for?
  17. What drugs were shown to be present in your system?

*Have you been accused of DUI in Florida? *


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