Worst Pills, Best Pills

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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: chlordiazepoxide (klor dye az e POX ide)
Brand name(s): LIBRAX, LIBRIUM
GENERIC: available FAMILY: Benzodiazepines
Find the drug label by searching at DailyMed.

Do Not Use [what does this mean?]
Generic drug name: clorazepate (klor AZ e pate)
Brand name(s): GEN-XENE, TRANXENE
GENERIC: available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: diazepam (dye AZ e pam)
Brand name(s): DIASTAT, DIASTAT ACUDIAL, DIAZEPAM INTENSOL, VALIUM, VALTOCO
GENERIC: available FAMILY: Benzodiazepines
Find the drug label by searching at DailyMed.

Do Not Use [what does this mean?]
Generic drug name: estazolam (est AZ oh lam)
Brand name(s):
GENERIC: available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: flurazepam (flure AZ e pam)
Brand name(s):
GENERIC: available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: halazepam (hal AZ e pam)
Brand name(s):
GENERIC: available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: lorazepam (lor AZ e pam)
Brand name(s): ATIVAN, LORAZEPAM INTENSOL
GENERIC: available FAMILY: Benzodiazepines
Find the drug label by searching at DailyMed.

Do Not Use [what does this mean?]
Generic drug name: oxazepam (ox AZ e pam)
Brand name(s):
GENERIC: available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: prazepam (PRAZ e pam)
Brand name(s):
GENERIC: available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: quazepam (KWAYZ a pam)
Brand name(s): DORAL
GENERIC: not available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: temazepam (tem AZ e pam)
Brand name(s): RESTORIL
GENERIC: available FAMILY: Benzodiazepines
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Do Not Use [what does this mean?]
Generic drug name: triazolam (trye AY zoe lam)
Brand name(s): HALCION
GENERIC: available FAMILY: Benzodiazepines
Find the drug label by searching at DailyMed.

Do Not Use Except For Panic Disorder [what does this mean?]
Generic drug name: alprazolam (al PRAZ oh lam)
Brand name(s): XANAX, XANAX XR
GENERIC: available FAMILY: Benzodiazepines
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

See nondrug approaches in Sleeping Pills and Tranquilizers and buspirone.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

An increased risk of congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate, and chlordiazepoxide) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant when beginning therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant, they should communicate with their physicians about the desirability of discontinuing the drug.

Breast-feeding Warning

Benzodiazepines are excreted in breast milk. Taking a benzodiazepine (diazepam) caused nursing infants to become lethargic and lose weight. As a general rule, mothers taking benzodiazepines, including Xanax, should not nurse.

Safety Warnings For This Drug [top]

FDA BLACK-BOX WARNING


Concomitant use (use at the same time) of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Patients must be followed for signs and symptoms of respiratory depression and sedation.

The use of benzodiazepines exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing benzodiazepines and throughout treatment, each patient’s risk for abuse, misuse, and addiction must be assessed.

The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of benzodiazepines after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue benzodiazepines or reduce the dosage.


 

The best way to reduce the risks from sleeping pills and tranquilizers is to avoid them if at all possible. Before taking one of these powerful medications, see the Sleeping Pills and Tranquilizers section of this site for nondrug alternatives to try before using either sleeping pills or tranquilizers.

Warning: Do Not Use Alprazolam (XANAX) Except for Panic Disorder

Panic Disorder and related conditions must be evaluated by the appropriate mental health professional. Specialized psychotherapy decreases the need for drugs for this condition. A psychiatrist may be able to prescribe less hazardous medications for this condition.

Facts About This Drug [top]

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...

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.

Adverse effects

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).[1]

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%.[2] 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.[3]

Hallucinations

Visual hallucinations with temazepam use have been reported. These hallucinations stopped when temazepam use was stopped.[4]

Dementia

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.

Studies show...

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.”[5]

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.[6]

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.[7]

Best options for older adults

Some experts believe oxazepam (available in generic only) and temazepam are the drugs of choice for older patients.[8] 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.[9]

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.[10]

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)[11]

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.[12]

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).[13],[14]

last reviewed January 31, 2021