FDA black box warnings and Z-drugs

Catching Zzz’s

While it’s tempting to claim “Z-drugs” got their name because they help you catch zzz’s, the truth is a little more literal: Most of the drugs have a “Z” in their name. Zolpidem, Zaleplon, and Eszopiclone, to name a few, are better known by their calmer-sounding brand names: Ambien, Lunesta, and Sonata. Similar to benzodiazepines, Z-drugs work by increasing the effects of a relaxing chemical in the brain called GABA, which has a sedating effect that can help with falling asleep, staying asleep, or a combination of both.

Tossing and turning

Chantel recently accepted a frontend engineering role at a mission-driven company — a job she’s always wanted. After freelancing for most of her career, this will be her first full-time job. Unfortunately, Chantel has suffered from insomnia for nearly 10 years and now that she’s starting a 9-to-5 job, she won’t have the flexibility to sleep in after a poor night of sleep. She’s worried that her challenges with sleep will negatively impact her work performance. She starts to think, “If I don’t sleep at night, my work will suffer and I’ll be fired!” This negative thinking – sometimes referred to as catastrophizing — is all too common for sufferers of insomnia. These thoughts fuel a vicious cycle: Worrying about sleep actually leads to lower quality sleep, further perpetuating the negative cycle of insomnia.  

Could a Z-drug be Chantel’s answer?

Chantel isn’t alone: More than half of US adults have trouble sleeping, and one in five people meet the criteria for chronic insomnia. For some, Z-drugs are a viable solution. They work quickly and reduce the time it takes to fall asleep by 20 minutes on average – just what Chantel is hoping to achieve as she starts her new job. And unlike benzodiazepines, Z-drugs have a lower-risk of rebound insomnia (i.e., experiencing even more difficulty initiating or maintaining sleep) once they’re discontinued. These benefits help explain why Z-drug prescriptions have been climbing over the last decade.

What are the downsides of Z-drugs?

But Z-drugs come with their fair share of downsides. These medications increase the risk of motor vehicle accidents, as well as falls and fractures in the elderly. In fact, the FDA has issued a black box warning — the strictest warning that can be issued for a drug by the FDA — indicating that Z-drugs can cause sleepwalking and other sleep behaviors, which can even lead to injury and death in rare cases. In addition, people quickly build a tolerance to Z-drugs, which is why sleep experts recommend taking them for a short period of time (e.g., 4 weeks or less). But that’s easier said than done. Discontinuing Z-drugs can cause temporary rebound insomnia, making it harder for people to stop taking them, ultimately resulting in use for a longer time than what is recommended.

Clinical guidelines for treating insomnia

Chantel decides to do some research on the best treatments for chronic sleep problems, and she quickly learns that Z-drugs are not the first-line recommended treatment for insomnia. Instead, the expert guidelines from the British Association for Psychopharmacology, European Sleep Research Society, and American College of Physicians all recommend cognitive-behavioral therapy for insomnia (CBT-I) as the first-line intervention. CBT-I is a skills-based approach that works to improve sleep through behavior change, such as sticking to a consistent sleep schedule, using a wind-down routine to get ready for sleep, and training the body to associate the bed with sleep. Beyond behavior change, CBT-I helps to improve negative thought patterns, like Chantel’s hard to control worry about sleep. According to sleep experts, CBT-I consistently helps people fall asleep faster and get better quality sleep, without side effects.

Chantel’s road to recovery

Chantel realizes CBT-I is her best bet for overcoming her insomnia based on medical guidelines and research evidence. But as soon as she starts looking for a behavioral sleep specialist, she realizes there is an extreme shortage of providers who are trained and credentialed to deliver CBT-I. Research published in 2016 showed that there are only 752 behavioral sleep specialists in the US, and roughly 63% of cities have no behavioral sleep specialists at all.

Fortunately, the world is changing. If medication is not preferred and in-person therapy is inaccessible, Chantal now has the option to use digital therapeutics. Digital therapeutics are software programs that function like medicine to treat insomnia. They’re clinically evaluated to ensure that they lead to improvements in health — it’s just that, instead of taking a pill or struggling to find a therapist, people are using digital programs on computers and smartphones, which are instantly available. Similar to psychiatric medicines, digital therapeutics can reach a large number of people quickly, and deliver a consistent quality of care. But unlike Z-drugs, digital therapeutics have software algorithms that allow care to be personalized to the individual, without side effects.

Chantel has access to SleepioRx — a safe and effective digital therapeutic for insomnia — and starts learning healthy sleep habits right away. Now when Chantel sets her alarm for work, she feels a little more confident that sleepless nights will soon be a thing of the past.

SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia/insomnia disorder as an adjunct to usual care in patients aged 18 and older. Sleepio is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider. Patients should read the indications for use.