FDA Halves Dosing Recommendations for Ambien

Ambien and similar sleep medications have been in the spotlight since the FDA recently issued new and lower dosing recommendations due to recent investigations suggesting that morning drowsiness put people at higher risk for car accidents. Lab studies and driving tests revealed that these drugs remain in patients’ bloodstreams at levels that impact morning driving. Women in particular are at risk of this lingering side effect.

Ambien is the most commonly prescribed prescription drug for insomnia in the US. If you’re one of the millions of Americans suffering from insomnia and using sleep medications, here’s a look at what these new FDA recommendations mean for you.

The FDA’s new dosing recommendations affect all drugs containing Zolpidem (brand names Ambien, Ambien CR, Edluar, and Zolpimist). These medications are used to decrease the time it takes to fall asleep and to improve quality and duration of sleep. Other sleep medications, such as Lunesta and Sonata, weren’t affected by the dosing change.

The change lowers the recommended dose by half–from 10mg to 5mg for immediate-release formulas (Ambien and its genetic form) and from 12.5mg to 6.25 mg for controlled-release formulas (Ambien CR). The rationale behind the new recommendations is that using lower doses will decrease the level of the drug that remains in the bloodstream in the morning, reducing the risk of impaired driving.

Since Ambien hit the market in the early nineties, the FDA received numerous reports of unsafe driving incidents among patients taking Ambien, but the link between the two had been difficult to prove. The growing number of reports placed the labeling of adverse side effects for sleep medications under scrutiny, making it clear that there was a need for labeling changes and further investigation on the safety of these drugs.

New clinical studies revealed that women taking Ambien are more likely than men to have high levels of the drug remaining in their bloodstream the morning after taking the medication.

Ambien is metabolized primarily in the liver, and since women have lower concentrations of liver enzymes than men, they metabolize the drug more slowly. This results in higher levels of the drug remaining in their bodies in the early morning, increasing the risk of falling asleep at the wheel.

Note: While the decreased dosing is aimed primarily at women, the FDA suggests the lowest effective dose for men as well.

In addition to morning sleepiness, Ambien and similar sleep medications have a lot of other known side effects. About 10 percent of people taking Zolpidem experience headaches, dizziness, and somnolence (drowsiness). Abnormal dreams, depression, rash, and gastrointestinal irritation (gas, bloating, and abdominal pain) are slightly less common side effects. More serious but far less common reactions include thoughts of suicide, aggressive behavior, and complex sleep behaviors such as sleep-eating and sleepwalking; these occur in fewer than 1 percent of patients.

The short answer: You should take the lowest amount of medication that is effective, for the shortest amount of time.

However, finding the right dosing regimen may be complicated if you’ve been using the medication at a higher dose for a long period of time. In addition, the effectiveness of the medication at a lower dose may vary from person to person. Certain situations may warrant a higher dose; for example, if you have clearly documented insomnia, have been on the medication for a long period of time, and/or have tried other treatment regimens without success.

Ultimately, the decision to use Ambien or similar medications at a particular dose is an individual one. Talk to your provider about your dosing, and remember:  It may take time and practice to discover what works best for a good night’s rest.

Insomnia is a complex diagnosis that often stems from organic causes such as thyroid disturbances and depression or anxiety. A health care provider can help rule out these and other causes for sleeplessness with a thorough examination. If the provider doesn’t find an organic cause for insomnia, there are many steps you can take that don’t involve regular use of a prescription-strength sleep aid.

A more effective, long-term treatment strategy for insomnia is understanding the principles of sleep hygiene and practicing good sleep habits. If sleep hygiene isn’t enough to solve the problem, cognitive behavioral therapy for insomnia (CBT-I) may be beneficial. Finally, there are also a lot of over-the-counter natural sleep aids that may be effective for occasional bouts of insomnia.