Side effects of sleep medications: FDA recommends cutting dose in half for women

(June 3, 2018) updated November 20, 2021

Ambien, approved in 1992, is part of the class of insomnia drugs called "non-benzodiazepines," which are DEA Schedule IV drugs and act on the body in a similar way to benzodiazepines (which are usually used as tranquilizers or for anxiety). The non-benzodiazepines are supposed to be less habit forming with less severe side effects. Nevertheless, abnormal behaviors and amnesia-related side effects are warned about in patient inserts and on television commercials. "Sleep driving" is one of the most dangerous examples, and the FDA has received more than 1,000 reports of sleep driving mishaps involving Ambien. On AskaPatient, more than 75 users commented on sleep driving in their reviews. Some people have regretted making phone calls or sending emails or posting online while under the influence of the drug; in 2018, a celebrity's offensive tweets led to the term "Ambien-tweeting."

Because it became increasingly evident that the insomnia drugs could impair a person's ability to function even the day after taking the drug, in 2013 the FDA required that manufacturers cut the recommended dosage for women in half and suggested that the dosage also be reduced for men.

In August 2019, the safety label for the drug Ambien (zolpidem),  Sonata, and Lunesta were updated to add the following:
"Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior." The revised label also lists these activities as "complex sleep behavior" that can happen while not being fully awake:
"Sleep-walking, sleep-driving, preparing and eating food, and making phone calls."

Non-benzodiazepines for insomnia include:  Ambien, Lunesta, and Sonata along with their generic versions. A benzodiazepine (also Schedule IV) prescribed for insomnia is Restoril (Temazepam). The chart below gives average ratings scores and links to one of the more frequently reported example side effects on From the drug review pages, click on the "Review Summary" or the "Adverse Event Report" to see broad categories of side effects. Or, use the Advanced Search feature to find side effects by keyword.

RatingExample Side Effect:
Ambien 3.10amnesia

vivid dreams

Lunesta 2.80metallic taste in mouth

Amnesia or memory issues
Sonata 2.80hallucination

memory loss
Restoril 3.00bad dreams

Key to ratings scores:
5-Very Satisfied: this medicine cured me or helped me a great deal.
4-Satisfied: this medicine helped.
3-Somewhat Satisfied: this medicine helped somewhat.
2-Not Satisfied: this medicine did not work to my satisfaction.
1-Dissatisfied: I would not recommend taking this medicine.

More Reading:
- FDA requires cuts to dosages of ambien and other sleep drugs (New York Times article)
- FDA Consumer Update: Some Sleep Drugs Can Impair Driving
- List of drugs often used for insomnia in the "Sedatives - Hypnotics" category
- Find all current drug labels at the NIH's Daily Med web site.
- "Pharmacological Treatmen of Insomnia"
The article provides an overview of the various drug treatments for insomnia, including over-the-counter products.
These include BZD (benzodiazepine) and non-BZD (Non-benzodiazepine) drugs, the melatonin agonist ramelteon, the sedating antidepressant doxepin, and the orexin receptor antagonist suvorexant. Agents approved for other indications, such as the antidepressants trazodone and mirtazapine, are also used for insomnia. Over-the-counter alternative therapies include antihistamines, melatonin, and the herbal products valerian and kava. Includes a table summarizing the FDA-approved insomnia treatments.