Diana Zuckerman, PhD: National Center for Health Research
Most of us have experienced sleepless nights that leave us so tired and miserable the next day that we’ll try almost anything that claims to be helpful. The newest sleep medication, called Belsomra, claims to be just the answer. But, the truth is that Belsomra doesn’t actually improve your sleep that much. It might help you fall asleep a few minutes faster or stay asleep slightly longer. But this small benefit comes with some big safety concerns, such as being too drowsy to drive the next day — or feeling like you can’t move or talk.
Other sleeping pills, such as Ambien and Lunesta, are known to cause problems including sleepwalking, hallucinations, and morning fatigue. And people taking any sleeping pills, even over-the-counter sleeping pills –most of which contain the antihistamine Benadryl (diphenhydramine) — tend to die younger and are more likely to die from cancer.
Belsomra is a newer type of sleeping pill called an orexin-receptor antagonist. It acts differently in the brain compared to older sleep medications, which is why some doctors thought that we finally found the magic pill. However, studies show that Belsomra helps people fall asleep only about 6 minutes faster, on average. And it doesn’t help people stay asleep that much longer either – only about 20 minutes longer.
The irony is that people who have insomnia take sleeping pills so that they can function well the next day. They want to be able to think clearly, drive a car safely, take care of their family, and do well at their job or in school. And yet, people who take Belsomra don’t feel more refreshed. Instead, more people who took Belsomra felt drowsy the next day compared with those who took a placebo. In fact, two people who took the 20 mg dose the night before were so drowsy the next day they had to stop a driving test. Slightly more people in the Belsomra group were involved in driving accidents or got traffic tickets and reported hallucinations or sleep paralysis—a feeling that you can’t move or talk while falling asleep or awakening.
If 20 mg made people drowsy the next day, what about 10 mg? Merck, the manufacturer of Belsomra, doesn’t think a lower dose is the answer: “And what we see in the overall picture is that 10 milligrams is not an effective dose.,” according to W. Joseph Herring, M.D., Merck’s executive director of clinical research, neuroscience, and ophthalmology.3
What are your alternatives? As noted above, other sleeping pills have other problem side effects. In fact, in April 2019, the FDA announced a Boxed Warning for three other “sleeping pill” medications: eszopiclone (brand name is Lunesta), zaleplon (brand name is Sonata), and zolpidem (Brand names are Ambien, Ambien CR, Edluar, Intermezza, and Zolpimist).1 The FDA stated that they added this Boxed Warning (their most prominent warning, similar to the ones on tobacco products) based on reports to the FDA indicating the “risk of serious injuries caused by sleepwalking, sleep driving, and engaging in other activities while not fully awake,”2 The FDA warns that these can occur even in someone who has never had a problem with the pills before, or can occur the first time the patient uses the medication2. In some of the reported cases, these behaviors resulted in death.2 The FDA also added a “Contraindication” to the label that warns “to avoid use in patients who have previously experienced an episode of complex sleep behavior” with any of these medications.2 The “complex sleep behaviors” reported with these medications include sleepwalking and sleepdriving, but can also include other behaviors that people do when awake.2 Patients need to discuss those previous experiences with sleeping pills with their physician before deciding if any of these drugs are appropriate.
For more information about how to improve your sleep without medications, see our article: What you can do to improve your sleep and your health.
1. FDA Adds Boxed Warning to Insomnia Drugs. https://www.medscape.com/viewarticle/912402?nlid=129596_3901&src=wnl_newsalrt_190430_MSCPEDIT&uac=140425SY&impID=1951351&faf=1
2. FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia
3. Transcript of FDA Peripheral and Central Nervous System Drugs Advisory Committee, May 22, 2013, pg. 268. https://wayback.archive-it.org/7993/20170404154550/https:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM362214.pdf