The 13 sleeping pills and tranquilizers discussed in this profile all belong to the benzodiazepine family. Called sedative hypnotic drugs, and sometimes referred to as sleeping pills, they are used to...
Do Not Use: We have designated all of these drugs as Do Not Use — except for alprazolam (XANAX, XANAX XR), which is designated as Do Not Use Except for Panic Disorder — because these drugs are sedating, addictive and increase the risk of falls and hip fractures. Safer drugs are available.
The 13 sleeping pills and tranquilizers discussed in this profile all belong to the benzodiazepine family. Called sedative hypnotic drugs, and sometimes referred to as sleeping pills, they are used to induce or maintain sleep and to treat acute anxiety. Although these drugs are widely used by older adults, they present significantly higher risks to people over 60, and many older people who use these drugs should not be taking them. These drugs have significant risks and often are prescribed unnecessarily.
Some of these sleeping pills stay in the body so long that patients remain sedated during the daytime, whereas other drugs in this family leave the body so quickly that patients can experience rebound insomnia and become confused the following day. Further, benzodiazepines lack proven long-term benefits.
Benzodiazepines can cause unsteady gait, dizziness, falling (which increases the risk of hip fractures), automobile accidents (which may cause injury), cognitive impairment, memory loss and addiction.
There have been reports of sleepwalking (inappropriate or strange automatic behavior while asleep, including binge eating and house painting) and serious allergic reactions in patients using sleeping pills such as estazolam (available in generic only), flurazepam (available in generic only), quazepam (DORAL), temazepam (RESTORIL) and triazolam (HALCION).
Risk of hip fracture
Available evidence strongly suggests that the use of benzodiazepines in older people increases their risk of hip fracture by at least 50%. Due to the high morbidity and mortality associated with hip fracture, older people should rarely be prescribed benzodiazepines. Many older people already taking these drugs should withdraw from them under appropriate medical supervision.
Visual hallucinations with temazepam use have been reported. These hallucinations stopped when temazepam use was stopped.
A study published in the British Medical Journal provides the strongest evidence to date linking benzodiazepine use to an increased risk of dementia. This large, carefully conducted study used a prospective design and avoided some of the key weaknesses of earlier studies. The authors found that benzodiazepine use by elderly patients increased the risk of developing dementia by approximately 40-60%.
Worst Pills, Best Pills News categorizes all of the benzodiazepines approved for anxiety or insomnia in the U.S. as "Do Not Use" drugs, with the exception of alprazolam (XANAX XR, XANAX), which is listed as "Do Not Use" except for panic attacks.
Our review of the benzodiazepine drugs reveals that they are all effective; however, each drug has a different degree of safety.
High incidence of adverse effects with flurazepam
According to the World Health Organization, older adults should not use flurazepam “owing to a high incidence of adverse effects.”
Drugs can leave body too quickly or too slowly
Some benzodiazepines are cleared out of the body very slowly, especially in older adults. As a result, they can accumulate in the body, resulting in a greater risk of adverse events. This effect is particularly evident for the following drugs: diazepam (DIASTAT, DIASTAT ACUDIAL, DIAZEPAM INTENSOL, VALIUM, VALTOCO), chlordiazepoxide (LIBRIUM, LIBRAX), clorazepate (GEN-XENE), quazepam and estazolam.
In contrast, triazolam is very short-acting, and it can cause rebound insomnia (increased sleeping problems when the drug effect has worn off); anxiety; serious amnesia (forgetfulness or memory loss); and violent, aggressive behavior.
Increased risk of death
A March 2014 study in the United Kingdom found an increase in the risk of death in people using tranquilizers or sleeping pills compared with people not using them. The results were similar to those from a 2012 study. Concerns about the effect of these drugs on premature mortality have been fueled by studies documenting increased risk of dementia, daytime fatigue, lack of coordination, falls, road traffic incidents, and pneumonia and other infections.
Link to Alzheimer's disease
The April 2015 issue of Worst Pills, Best Pills News highlighted information from a 2014 article in the journal JAMA Psychiatry that found that benzodiazepines were overprescribed in the U.S. It also highlighted a 2014 study in the British Medical Journal that found a link between benzodiazepine use and Alzheimer’s disease in elderly patients.
Best options for older adults
Some experts believe oxazepam (available in generic only) and temazepam are the drugs of choice for older patients. Public Citizen recommends against using either of them.
One suitable alternative for patients who require a tranquilizer for acute anxiety is the non-benzodiazepine buspirone (BUSPAR), which we have designated Limited Use.
Patients taking a tranquilizer for anxiety should ask their doctors to re-evaluate the need for this drug. If patients do need such a drug, they should be taking buspirone.
A placebo-controlled clinical trial published in 2019 found that use of valium in the evening before bedtime significantly increased blood pressure and heart rate during the night in healthy elderly individuals.
Regulatory actions surrounding benzodiazepines
1992: Public Citizen’s Health Research Group petitioned the Food and Drug Administration (FDA) to ban triazolam because it is very similar to the sleeping pill estazolam, which was already on the market. The two drugs are in the same chemical subclass. According to the highly regarded Medical Letter on Drugs and Therapeutics, there is no reason to use triazolam.
2007: In March, the FDA asked manufacturers of these drugs to update the drug product labels concerning potential risks associated with these medications, including “severe allergic reactions and complex sleep-related behaviors.” Allergic reactions included anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling). Complex sleep-related behaviors included sleep-driving, making phone calls and preparing and eating food while asleep.
The following medications were specifically mentioned in the FDA advisory:
- zolpidem (AMBIEN/AMBIEN CR — Sanofi Aventis)
- butabarbital (BUTISOL SODIUM — Medpointe Pharmaceuticals HLC)
- pentobarbital and carbromal (CARBRITAL — Parke-Davis)
- flurazepam (DALMANE — Valeant Pharmaceuticals)
- quazepam (DORAL — Questcor Pharmaceuticals)
- triazolam (HALCION — Pharmacia & Upjohn)
- eszopiclone (LUNESTA — Sepracor)
- ethchlorvynol (PLACIDYL — Abbott)
- estazolam (PROSOM — Abbott)
- temazepam (RESTORIL — Tyco Healthcare)
- ramelteon (ROZEREM — Takeda Pharmaceutical)
- secobarbital (SECONAL — Eli Lilly)
- zaleplon (SONATA — King Pharmaceuticals)
The FDA also requested that Medication Guides be developed for consumers. The drugs in the benzodiazepine family are a few of a limited number of drugs for which the FDA requires an FDA-approved Medication Guide to be dispensed when the prescription is filled. (Click here to view a list of FDA-approved Medication Guides.) An FDA advisory committee has unanimously recommended that all prescription drugs be accompanied by such Medication Guides, but at present, less than 5% of drugs are. The other 95% of drugs are accompanied by unregulated, often dangerously incomplete information leaflets not approved by the FDA.
2016: In August, the FDA added a black-box warning, the strongest warning used by the FDA, to all opioid and benzodiazepine drugs stating that serious adverse effects — including respiratory depression, coma and death — have occurred when these medications are used together.
2020: The FDA announced that it had requiried the black-box warning (see above) for all benzodiazepine drugs be strengthened to warn of the severe risk associated with the use of these drugs. A similar announcement was made by Health Canada (an agency in Canada similar to the FDA).,