“Almost every month, new information appears about the risks of [sleeping pills],” he says.
Kripke’s concerns aren’t isolated. Dr. Barbara Phillips, who is a sleep researcher at University of Kentucky, called on FDA in support of Kripke’s petition to “immediately limit” the most commonly prescribed sleeping pills. She described most prescribing doctors as being “woefully unaware” of sleeping pills’ risks and possibly more likely to prescribe the medications than they are to discuss the risks with their patients.
University of California, Los Angeles (UCLA) sleep researcher Jerome Siegel, who is a past president of Sleep Research Society and who helped to discover the cause of narcolepsy, also supports Kripke’s petition. He suggests that FDA consider limiting the use of common sleeping pills to “1 or 2 weeks with no refills” or “completely withdraw them from the market.”
An FDA spokesperson tells us that Kripke’s petition “raises complex issues requiring extensive review and analysis,” and the agency will respond after it completes its analysis of the petition. FDA wouldn’t tell us how long that the review process will take nor comment on Kripke’s petition.
In the past 4 years, FDA acted to address the hangover effect of sleeping pills. In 2013, FDA halved the recommended starting dose of Ambien for women and warned users of sleeping pills that contain zolpidem that they shouldn’t drive the day after they take the medication. In 2014, FDA reduced the recommended starting dose for Lunesta.
Kripke worries that FDA will “delay for years” taking action on his petition. He claims that manufacturers know that sleeping pills are dangerous and won’t conduct post-market clinical trials out of fear of what they’ll find. We asked Pharmaceutical Research and Manufacturers of America, which is an industry organization, to respond to Kripke’s call, but the organization declined and said it doesn’t comment on “specific products.”
BACK TO SLEEP. Experts tell us that plenty of evidence exists that cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for chronic and short-term insomnia. CBT-I consists of four to eight treatment sessions that involve in-person therapy and are spaced several weeks apart.
In 2008, AASM recommended CBT-I, rather than sleeping pills, as its first-choice treatment for chronic insomnia. The January 2017 issue of JAMA Psychiatry notes that the principles of CBT-I are “well-tested.”
CBT-I sessions are designed to help patients to change their sleep-related attitudes and behaviors, such as going to bed at the same time every day, avoiding the intake of caffeine after 4 p.m., refraining from eating and exercising shortly before bedtime, and using the bed only for sleep and sex.
At the beginning of the therapy, patients typically feel worse before they feel better, because they have to get out of bed upon waking, so they create a sleep deficit that helps them to fall asleep the next night, says Jennifer Martin, who is a clinical psychologist and a sleep expert at UCLA. A 2015 study that was published in Annals of Internal Medicine found that people who undergo CBT-I fall asleep about 24 minutes faster than do those who take a sleeping-pill placebo, and that they maintained the benefits of therapy long term.
CBT-I falls under mental-health coverage. If you have insurance that covers mental health, your plan should pay for at least some of the cost of CBT-I. The cost can be steep. We found a range of $160–$200 for a 45-minute session.
Unfortunately, experts say the number of therapists who are trained in CBT-I falls short of the demand for it. Experts also say no standards exist for CBT-I, so treatment programs might differ from therapist to therapist. However, technology is expanding patient access. Recent studies suggest that CBT-I that’s in the form of online programs and mobile apps can be effective for people who are comfortable using those media.
Online CBT-I programs cost $45–$135 for weekly sessions that run 5–6 weeks. Sleep experts at Department of Defense developed a CBT-I app that’s available to download for free through the Apple iOS App Store and Android’s Google Play store. Online variations of CBT-I are “promising” in terms of their effectiveness to help users to sleep, according to the January 2017 issue of JAMA Psychiatry. However, experts say more studies are needed for researchers to conclude whether online or app-based CBT-I is as effective as are face-to-face sessions.
Sara Bongiorni is a regular contributor to Consumers Digest. She also has written for The Boston Globe, Christian Science Monitor and the Los Angeles Times.