A group of medicines that became wildly popular over the past 20 years ended up posing serious dangers to some of the people who took them and to public health.
But they also helped millions of people get a little bit more sleep.
Yes, we are talking about the insomnia drugs doctors wrote just under 40,000 prescriptions for Belsomra in May, for example, compared to 2.6 million for zolpidem, according to IMS Health, a drug sales tracking firm. But prescriptions for zolpidem were down from just under 3 million in December 2014. Similar drops occurred for the two other prescription insomnia drugs. — Ambien, now sold mostly as a generic called zolpidem, being the most widely known and prescribed. We’re also talking about Belsomra (suvorexant), the newest drug in this class and one of the most heavily advertised drugs over the last year.
After years of reports and attention to the risks associated with these medicines, their misuse and abuse, and their general lack of effectiveness at resolving the underlying causes of chronic insomnia, prescriptions for them are on the decline. And sales of Belsomra are in the dumpster.
Doctors wrote just under 40,000 prescriptions for Belsomra in May, for example, compared to 2.6 million for zolpidem, according to IMS Health, a drug sales tracking firm. But prescriptions for zolpidem were down from just under 3 million in December 2014. Similar drops occurred for the two other prescription insomnia drugs.
Why You Should Avoid These Meds If Possible
But here’s the bottom line for people who occasionally have trouble sleeping (most of us) or the unlucky 5 to 10% who have chronic insomnia: Don’t take these medicines at all if you can avoid it, and if you do need to take one, do so for the shortest time possible. Not more than a week or so. A few days would be better.
Why? The mediocre effectiveness of insomnia drugs coupled with serious side effects and misuse should keep them out of your medicine cabinet. Here are some facts about the effectiveness and side effects of these medicines, as well as data on their misuse, courtesy of Consumer Reports Best Buy Drugs. Additional information was provided by Steven Woloshin, MD and Lisa Schwartz, MD, both of the Geisel School of Medicine at Dartmouth, Thomas Moore of the Institute for Safe Medical Practices, and the FDA:
- Though studies vary, as do individual experiences, time to fall asleep after taking zolpidem and the 2 other older insomnia drugs is improved by 6 to 20 minutes compared with placebo; time staying asleep is extended by 25 to 45 minutes compared to placebo.
- People taking Belsomra fell asleep 6 minutes faster than those taking a placebo; they stayed asleep 16 minutes longer.
- 2/3 of people taking zolpidem use it for weeks, months or even years — a pattern of use at significant variance with the FDA and manufacturer’s recommendations of 7 to 10 days use max. And, in one analysis, 1 in 5 people who took zolpidem combined it with an opioid, increasing their risk of potentially fatal depression of the central nervous system not to mention other ill effects.
- 2%-6% of people taking lower doses of zolpidem experience next day drowsiness, even when they had taken the drug 6 to 7 or more hours prior to waking up; 7% to 15% of people taking higher doses of zolpidem experience next day drowsiness. (Because of this side effect and its link to traffic accidents and other untoward events, the FDA in 2013 lowered the recommended initial dose.
- 7% of people taking either the 10mg or 20mg dose of Belsomra experienced next day drowsiness, compared to 3% who took a placebo, in clinical trials involving 1,784 patients.
- Sleep-walking or doing other activities when you are asleep like eating, talking, having sex or driving a car have all been associated with insomnia medicines, including Belsomra. So have memory lapses, and hallucinations. Generally, fewer than 1 in 10 people experience these problems.
- 2 in every 100 people who took Belsomra experienced the very frightening side effect of temporary muscle paralysis and/or an inability to speak. Essentially, they were semi-awake but could not move or speak. This rare but extremely unpleasant potential side effect is believed to be one reason doctors have been reluctant to prescribe the drug.
- All the insomnia medicines, including Belsomra, carry a risk of dependency. It’s not so much physical dependency, as happens with opioids or benzodiazepines like Xanax. It’s more of a psychological dependency, abetted by rebound insomnia. That’s when you stop taking the medicine and, for a while, you have even more trouble falling or staying asleep.
- By the end of last year, the FDA had received 2,378 reports of adverse events/problems associated with Belsomra, a relatively high rate of reported events given that less than 500,000 prescriptions have been written for the drug. The most frequent problem cited was that the drug was ineffective (38% of reports). The next most frequent was sleep disturbance (27%), which included abnormal dreams, hallucinations, and sleep paralysis (59 reported episodes).
So, doctors and patients appear to be getting wise to the downside of these medicines, and they have resisted Belsomra. Though this resistance is also probably to due to its cost: $70 to $80 for 7 pills compared to $10 to $20 for 7 to 10 zolpidem pills.
While the trend suggests, at long last, more caution in prescribing these medicines, millions of prescriptions are still being written. There are many reasons for this, the main one being that 1 in 4 Americans say they have sleep problems.
If you are among such people, here’s wise advice from Consumer Reports:
Having occasional trouble sleeping is a universal human experience. Don’t take a pill if you’ve had trouble sleeping for just a couple nights, especially if the sleep disturbance is due to job or relationship stress or a temporary life upset. This almost always resolves in time.
Before taking a pill, try improving your sleep habits. Studies show this works. Among the techniques: Relaxation training, setting and sticking to consistent bedtimes and wake-up times, regular exercise, quitting smoking, cutting back on caffeine and alcohol in the afternoon and evening, keeping your bedroom quiet and dark and not watching TV or using a computer in bed (including a smartphone). Read a book instead.
If you still experience problems and/or have been diagnosed with chronic insomnia (three or more nights a week of poor sleep for 8 weeks or more), try cognitive-behavioral therapy. This involves working with a therapist (possibly at a sleep clinic) to learn a new set of behaviors around sleep. Numerous studies show CBT is as effective as sleeping pills in helping people with chronic insomnia.
If you still want to try a chemical sleep aid, try nonprescription drugs containing an antihistamine For example, diphenhydramine, the active ingredient in Benadryl, is also sold as a sleep aid under the brand names Nytol and Sominex, and as a generic), or doxylamine (Unisom and generic). Diphenhydramine is also in Advil PM and Tylenol PM, though you should steer clear of these products unless you are also experiencing pain or fever. Don’t take any of these over-the-counter drugs for more than a few nights. And don’t take one if you are also taking any other medicine that causes sedation.
Don’t mix any kind of sleeping pill with alcohol. This advice applies to people of all ages, but is especially important for people over age 65, who are prone to falls and the cumulative sedative effects of multiple medicines.
Steven Findlay is an independent medical and health policy journalist and a contributing editor/writer for Consumer Reports. He derives some of his posts and insights from Consumer Reports Best Buy Drugs, a grant-funded public information and education program that evaluates prescription drugs based on authoritative, peer-reviewed research.