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Sleepless nights; nights full of tossing and turning. It happens to all of us–but for some it’s more frequent than others. In fact, an estimated 50 to 70 million American adults suffer from sleep disorders like insomnia or obstructive sleep apnea. Many turn to prescription sleep medications for relief– but women are more likely to take sleep drugs than men. About 3.1 percent of American men and 5 percent of American women report having used a prescription sleep medication within the last 30 days.

What does this use of sleep aids mean for women? Read on to learn more about sex differences in sleep and sleep drugs.

Sex Differences and Sleep

There are distinct biological and physiological differences between women’s and men’s sleep. According to the Society for Women’s Health Research (SWHR®), sex chromosomes, as well as gonadal hormones play a role in how individuals of each sex sleep, the sleep disorders they experience, and their responses to sleep medications. Examples of sleep differences between the sexes include women being more likely to experience disorders such as insomnia and restless leg syndrome (RLS); depression, pain, and stress are more likely to cause sleep disturbances in women than in men; and women being susceptible to changes in sleep throughout their lives, particularly at points when they experience hormonal and physical changes like puberty, pregnancy, and menopause.

Sex Differences and Sleep Drugs

Similar to how sex differences can impact sleep and sleep disorders, the way that these disorders are treated can also be affected by sex differences.

Case Study: Zolpidem

In 2013, the Food and Drug Administration (FDA) took a huge step by recommending sex-specific regulations for the prescription of sleep drugs that include zolpidem. This was groundbreaking in that it was the first time that the FDA had ever specifically recommended a sex-specific dosage for a particular medication. Zolpidem, which is used to treat insomnia, is found in Ambien, Edluar, and Zolpimist–all commonly prescribed sleep drugs. Zolpidem, a sedative-hypnotic, slows down activity in the brain.

The FDA reduced the recommended Zolpidem dosage for women to half of what was being prescribed. According to the SWHR:

This change in dosage was based on the discovery that women were metabolizing the same dose of drug 50 percent slower than men, which resulted in higher amounts of Ambien in women’s bloodstream leading to more excessive sleepiness in women compared to men.

Currently, the FDA is reviewing other popular sleep medications to determine if similar sex-specific recommendations should be issued for those as well.

Sleep Drugs and Contraceptives

We’ve all seen commercials for prescription drugs that recommend “talking to your doctor” before taking the advertised product, especially if currently using other medications. There’s a reason for that: drugs can interact and make other drugs less effective, causing unexpected side effects, or increasing the action of a particular drug. For women, it’s especially important to be aware of the interactions between hormonal contraception and sleep drugs.

Case Study: Modafinil

Combined hormonal contraceptives include the birth control pill, patches, injections, and vaginal rings like the NuvaRing. In the U.S., roughly 22 percent of women between the ages of 15 and 44 use contraceptives that fall into this category. Modafinil, which is a drug prescribed for certain sleep disorders like narcolepsy, sleep apnea, and excessive sleepiness, can lower the effectiveness of combined hormonal contraceptives. According to SWHR:

A specific enzyme in the liver breaks down modafinil to its composing molecules, which are then eliminated in the urine. The same enzyme that is responsible for clearing the body of modafinil also breaks down contraceptives. Studies have shown that, when taken together with modafinil, the overall blood levels of contraceptives decrease by 18 percent, resulting in potentially significantly lower effectiveness of the contraceptives.

Modafinil could also lower the effectiveness of other types of contraceptives, like emergency contraceptives such as the morning-after pill.

These interactions are also particularly concerning for women who become pregnant while still taking modafinil. Because modafinil lowers the effectiveness of contraceptives, this interaction is extremely unsafe for pregnant women and could potentially cause harm to a fetus.

Can contraceptives affect sleep?

Some evidence suggests contraceptives can cause changes in sleep for women. According to a 2001 study published in the European Journal of Physiology, oral contraceptives can affect sleep cycles and raise the body temperature of young women–another factor that plays a role in how well an individual sleeps. A woman’s menstruation cycle can also affect her body temperature, and therefore, how well she sleeps.

Sleep Drugs and Older Women

Women aged 55 and older are more likely to report sleepiness than men, and on average report 20 minutes fewer sleep per night than men. Post-menopausal women also report more fragmented sleep–they have a harder time staying asleep for long periods of time without waking up. According to the UCLA Sleep Disorders Center, physical factors can also disturb a post-menopausal woman’s sleep, such as arthritis and other pain-related conditions, chronic lung disease, heartburn, and a need to urinate more frequently.

But women aren’t alone in experiencing differences in sleep as they age–men do as well. As a result, both older men and women use sleep aids, which are often over-the-counter products. According to SWHR:

A recent health and wellness survey shows that 35 percent of people 60 years or older take OTC sleep medications at least 20 days a month. And 70 percent of them take OTC pain and sleep combination products, increasing the amount of the active ingredient in their system. This growing practice of self-medicating with OTC sleep products in an off-label way is alarming.

While those concerns are certainly valid–the mixing of medications, including over the counter drugs, can often cause problems; it’s still undetermined if there are any sex-specific effects of sleep medications on older women. Moreover, limited information is available as few sex-specific studies have been completed on how sleep medications and medications often taken by older women interact–a worrisome problem as older women continue to use these medications.

What’s Next?

The FDA is continuing to recognize that sex-differences are important when it comes to not only the differences in how American women and men sleep, but also how sleep medications can affect each sex. Additionally, nonprofits have been pioneering work studying and raising public awareness of these issues. Take, for example, the SWHR Interdisciplinary Network on Sleep. Launched in 2014, the network identifies areas in sleep health in which more work needs to be done specifically regarding women. According to SWHR:

The Society for Women’s Health Research is proud to bring together this interdisciplinary group to look at the critical issue of sleep in women’s health. We need greater focus on sex differences in sleep research to improve the diagnosis, treatment, and prevention of sleep disorders for both women and men. There continues to be knowledge gaps in the medical community regarding women and sleep. This SWHR Network is helping to address those gaps and highlight the importance of healthy sleep for everyone.

Sleep is important to all of us–woman or man, young or old. But recognizing the way different hormonal and physiological factors affect how we sleep, creating guidelines for medications based on those factors, and raising public awareness of risks associated certain sleep drugs and other medications are all steps in the right direction and will help us all sleep a little easier.

Resources

CDC: Prescription Sleep Aid Use Among Adults: United States, 2005-2010

Journal of Women’s Health: Exploring Sex and Gender Differences in Sleep Health: A Society for Women’s Health Research Report 

Huffington Post: Why We Need to Pay More Attention to Women’s Sleep

NIH/Medline Plus: Zolpidem

NIH/Medline Plus: Modafinil

FDA: Questions and Answers: Risk of Next-Morning Impairment After Use of Insomnia Drugs; FDA Requires Lower Recommended Doses for Certain Drugs Containing Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)

Huffington Post: Are Your Sleep Drugs Hurting Your Contraceptives?

Guttmacher Institute: Contraceptive Use in the United States 

RareConnect: Oral Contraception / Birth Control and Modafinil

European Journal of Physiology: Oral Contraceptives Alter Sleep and Raise Body Temperature in Young Women

UCLA Sleep Disorders Center: Sleep and Women

Huffington Post: Beware Risky Sleep Drug Usage in Older Americans, All for a Good Night’s Sleep

Sleep Review: Society for Women’s Health Research to Study Sleep Differences

Society for Women’s Health Research: Interdisciplinary Network on Sleep 

Society for Women’s Health Research

The Society for Women’s Health Research (SWHR®), is a national non-profit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease. SWHR is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women. For more information, please visit www.swhr.org. Follow us on Twitter at @SWHR. SWHR is a partner of Law Street Creative. The opinions expressed in this author’s articles do not necessarily reflect the views of Law Street.

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Kimberly Miller, a nun from Philadelphia, Pennsylvania, attended a book signing on November 7. After the event, the bookstore owner gave her some leftovers and a bottle of wine to bring back to the convent. That night, Miller took an Ambien, and had a glass of wine before going to bed. Little did Sister Kimberly know, her night had just begun.

She woke up the next day in New Jersey with a half-empty bottle in the back of her car and a blood alcohol content of .15, nearly double the legal limit. She had driven for almost an hour across state lines into New Jersey, and backed into a car repair shop before eyewitnesses called the police. When she was arrested for driving under the influence, she claims to have no knowledge of the incident.

Miller was hoping that her “Reverend Jekyll and Sister Hyde” experience might lessen her punishment–after all, she wasn’t even aware of the fact that she was driving at the time. In court, her lawyers argued that Miller experienced “pathological intoxication,” and never intended to drive drunk. Pathological intoxication is the phenomenon where a person’s personality and behavior drastically change after they consume alcohol, and it is a rare legal defense used to excuse a person from their drunken behavior. Typically, the defense is invoked when a person becomes exceedingly violent or impulsive after consuming a small amount of alcohol, while the nun’s experience involved her knowing consumption of Ambien. The defense must show that the condition’s effect was as strong as a mental illness would be in an insanity defense.

The presiding Judge Martin Whitcraft found that considering that Ambien has been on the market for over 16 years, a person consuming the medicine should reasonably know that its side effects worsen when paired with alcohol. The prosecutor drew attention to the specifics of the law, showing that the statute made no mention of intent–if you drive drunk, it’s your fault, whether or not you intended to do it.

Judge Whitcraft found the nun’s story to be unbelievable at best, saying “I find the defendant’s testimony less than credible. She testified that this wine was placed in the back seat by two sober, reasonable people.” Ultimately, Miller was found guilty of her DUI, but had the lesser charges against her dropped. Her license was suspended for 90 days, and she was placed on leave from her teaching position.

Sean Simon

Sean Simon is an Editorial News Senior Fellow at Law Street, and a senior at The George Washington University, studying Communications and Psychology. In his spare time, he loves exploring D.C. restaurants, solving crossword puzzles, and watching sad foreign films. Contact Sean at SSimon@LawStreetMedia.com.

The post Drunk Driving Nun’s Ambien Defense Fails appeared first on Law Street.

If you are going to a pharmacy for a particular drug, you’re often offered a choice — do you want the name brand or the cheaper generic? Generics have long been lauded for their ability to provide the same benefits to patients while also offering a less hefty price tag; however, recently generics have been getting more expensive, and people are wondering why. Congress announced this week that it’s going to launch an investigation into why the price of generic drugs is rising.

When a drug company develops a particular drug, it gets to hold the patent for approximately twenty years (some nations or jurisdictions give protections for a bit longer). During that period, that company is the only one that can produce that particular drug. After the patent expires, however, other companies can make a “generic” version of the drug.

There are certain regulations created by the Food and Drug Administration (FDA) to make sure that the generic drugs are able to be distributed. The FDA requires that a generic drug has the same active ingredients as the one that it is imitating, but not necessarily the same inactive ingredients (such as coloring). A generic has to perform the same function as the name brand, and it must of course meet the same health and safety standards.

Generic drugs tend to be less expensive than the name brands — and given the high cost of American health care, offer great and affordable options for consumers. However, it seems like the cost of these drugs is increasing. For example, the patent for Ambien, a popular sleep aid, recently expired. Now it’s a lot easier to get a generic version of Ambien for a cheaper price, and more people are able to get the product they need.

A study completed in August discovered that some generic prices have been dropping, while others have been rising almost exponentially. According to the Wall Street Journal:

The prices paid by pharmacies more than doubled for one out of 11 generics. And in a few cases – notably, the tetracycline antibiotic and the captopril blood pressure pill – the cost increases not only exceeded 1,000%, but topped 17,000%…. Yes, 17,000%.

Doctors have reported how troubling this kind of price increase can be in certain generic drugs for the patients who rely on them. Some patients who are on fixed incomes, such as those on Medicaid, may not be able to pay for the non-covered costs of the drugs if prices skyrocket that much. They may try to skip their prescriptions in an attempt to make ends meet. Not only is this obviously problematic for the patients themselves, but it also leads to more emergency room visits and a less healthy society in general.

That brings us to the investigation that Congress is evidently undertaking to try to figure out why exactly these generic prices are climbing so sharply and how to reverse the trend. The analysis is being pushed by Senator Bernie Sanders of Vermont and Representative Elijah Cummings of Maryland. We can all say a lot about the inadequacies of Congress, but this is a good move on its part. It’s really important that we get the prices of generics under control, because price increases like this are almost always passed directly to the consumer. With as many healthcare problems as we have, this is an issue that needs to be nipped in the bud as soon as possible.

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Anneliese Mahoney (@AMahoney8672) is Lead Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

Featured image courtesy of [Chris Potter/Stockmonkeys.com via Flickr]

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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