Article

Temazepam (Brand Names: Restoril, Normison, Norkotral, Nortem, Remestan, Temtabs, Temaze)
January 30, 20190632

 

What is temazepam?

Temazepam is a benzodiazepine. Benzodiazepines (also called benzos) are sedative-hypnotics that help fight insomnia and ease anxiety. Temazepam is used for the short-term relief of insomnia symptoms.1

Mallinckrodt Pharmaceuticals first introduced temazepam in 1965. The FDA approved temazepam in 1981.2

Temazepam is a controlled substance. You need a prescription from your doctor to buy it.1,3

 

How does temazepam work?

Similar to other benzos, temazepam works on the brain. It increases the effects of a chemical messenger called gamma-aminobutyric acid (GABA). GABA calms your brain, helping you drift off to dreamland.1,4

 

Figure 1: Structure of GABA. Modified from “GABA analogues” by Skullballoons, which is licensed under CC 4.0.

 

What are the properties of temazepam?

Temazepam is a white, crystalline substance that dissolves well in fat.10 This allows temazepam to enter the brain, which is rich in fat.1

Temazepam is one of the breakdown products of another benzo, diazepam. The body further breaks diazepam into simpler forms known as metabolites. One of those metabolites is temazepam. These metabolites maintain the effects of diazepam in the body.1

Temazepam is an intermediate-acting drug, with a slow onset of action. A 30 mg capsule takes between 1 and 2 hours to be fully absorbed by your body.10

 

Figure 2: Structure of temazepam. “Temazepam 200” by Emeldir is in the public domain.

 

Uses of Temazepam

Your doctor is likely to put you on a short-term course of temazepam (7 to 10 days)10 if you have one or more of the following conditions:

Major Uses of Temazepam

  • Insomnia
  • Temazepam helps you fall asleep and stay asleep longer if you are having problems sleeping.1,10
  • Anxiety
  • Your doctor may prescribe temazepam for a short amount of time when you first start taking an antidepressant, such as a selective serotonin reuptake inhibitor (SSRI). SSRIs are powerful anti-anxiety drugs, but they may take up to several weeks before they improve your symptoms.11 Taking temazepam when you first start a SSI may help control your symptoms until the SSI starts working. Temazepam is not used for long-term treatment of anxiety.10

Minor Uses1

  • Muscle spasms
  • Epilepsy
  • Panic attacks (rare)

 

Temazepam Dosage

Temazepam  comes in 7.5 mg, 15 mg, 22.5 mg, and 30 mg capsules. Depending on the dose, the capsules may be blue, red or pink.10

Dosage in Adults

The amount of temazepam your doctor choses to prescribe for you will depend on:

  • Your medical history
  • Other drugs you are taking
  • The condition your doctor is prescribing temazepam to treat
  • Your age

The most commonly prescribed dosages if you are:

  • An adult younger than 40 years old is 15 mg by mouth once a day at bedtime. Your doctor might increase the dosage if your symptoms do not improve. The maximum recommended dose of temazepam is 30 mg per day.10
  • An adult older than 40 years old is 7.5 mg once a day at bedtime. Older individuals are often started on this lower dose because they are at greater risk of serious side effects or an overdose than younger adults.3 This is because perfect liver and kidney function are required to remove temazepam from the body. As we age, our kidney and liver functions often slow down, making it harder for our bodies to get rid of this drug. Higher levels of the drug in the body increase the risk of negative side effects.1
  • Experiencing bouts of short-term insomnia (less than 7 days) is 7.5 mg once a day at bedtime. Research shows that 7.5 mg of temazepam is as effective as a 15 mg dose for short-term insomnia.2

Dosage in Children

Temazepam has not been tested in children. It is not known if it is safe or useful in children.3

 

Side Effects of Temazepam

More common side effects 3

  • Daytime drowsiness and sedation (reported in 9 percent of people)
  • Dizziness (reported in 4.5 percent of people)
  • Fatigue (4.5%)
  • Headache(2.5%)
  • Diarrhea (1.7%)
  • Feeling very happy without reason (1.5%)
  • Muscle weakness (1.4%)
  • Clumsiness and risk of falling (more common in older people and when taken at high doses)10
  • Memory loss (1%)
  • Loss of orientation
  • Difficulty carrying out normal activities (at high doses)
  • Dry mouth or increased thirst10
  • Numbness, burning, or tingling in the hands and/or feet
  • Depressed mood (1.7%)
  • Abuse and addiction (more common if taken for longer than 7 to 10 days)

 

You may have trouble sleeping for the first few nights after stopping temazepam. This is called “rebound insomnia”.10 Talk to your doctor if this problem does not go away on its own.

Serious side effects 3,10

Although rare, temazepam can cause serious side effects. Stop taking temazepam and contact your doctor at once if you experience any of the following symptoms:

  • Difficult or shallow breathing
  • Fast or pounding heart
  • Hallucinations
  • Aggression
  • Thoughts of suicide or of hurting yourself
  • Symptoms of an allergic reaction, such as hives, skin rash, or swelling of face, lips, or tongue
  • Dark urine
  • Clay-colored stools
  • Yellowing of the skin or eyes
  • Weird activities while sleeping, such as driving, eating, cooking, or making phone calls

 

Warnings for Temazepam

General warnings

Tell your doctor if you:

  • Have had an allergic reaction to temazepam or any other benzo.3
  • Have been diagnosed with asthma, chronic obstructive pulmonary disorder (COPD), or other lung diseases3,4
  • Benzos may cause your breathing to slow down if taken at higher doses; your doctor may want to monitor you more closely if you have a lung disease.
  • Have been diagnosed with kidney or liver disease:
    • The body gets rid of most of the benzos through the liver and kidneys. If you use temazepam and have end-stage liver or kidney disease, the drug can build-up in the blood. This puts you at greater risk of serious side effects or an overdose. Temazepam is safe to use with a mild liver problem (see below).1,3
  • Have a history of depression or suicidal thoughts or behavior3:
    • Long-term use of benzos can increase your risk of developing depression.3 If you have already been diagnosed with depression, you may be at greater risk for suicide if you take temazepam.9
  • Have a history of psychosis:
    • At higher doses, temazepam can cause psychotic symptoms in some people, including self-harm or violence against others.3
  • Have a history of drug or alcohol addiction:
    • If you are or have been addicted to alcohol or another substance, you are at higher risk of developing an addiction to temazepam.3
  • Have a history of seizures:
    • Sudden withdrawal of benzos can cause seizures. This is more common if you have a history of seizures.3,10
  • Glaucoma3
  • Myasthenia gravis (MG)3

 

If you take temazepam, you need to be able to get a full night’s sleep before having to be awake again. Temazepam has a negative impact on mental alertness.  It is best to discuss with your doctor if you need to perform activities that require  you to focus first thing in the morning.3,10

Do not take or stop temazepam without talking to your doctor. Do not stop taking it abruptly if you have been taking it for a long time. Your insomnia and anxiety can worsen or return if you try to go cold turkey. You may need to taper the dose to make sure that this does not happen.3,10

If you miss a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and take the next dose as you normally would. Avoid taking a double dose.10

You should not drive or operate any machinery after taking temazepam until you are fully awake.3

You should not drink alcohol while on temazepam. You should also avoid the use of other sedatives while taking temazepam.3

After taking temazepam, there is a risk that you may engaging in bizarre and dangerous activities, such as sleep-driving, without being able to remember it. Tell your doctor if someone informs you that you have been behaving strangely, even if you have no memory of the event.3

Warnings for special groups

 The Elderly

If you are an older individual, you are at higher risk of extreme sedation, dizziness or confusion. This puts you at greater risk of falling and fractures.  You can help prevent becoming dizzy by  sitting and standing up slowly.10

Pregnant Women

Tell your doctor if you are pregnant or wish to become pregnant. Temazepam is a “pregnancy Category X” drug.3 Drugs in this category may not be used during pregnancy. If taken during pregnancy, temazepam can lead to serious birth defects in your baby.5

Nursing Mothers

Tell your doctor if you are nursing or plan to nurse. Small amounts of temazepam can pass into breast milk. This can cause sedation and feeding problems in the baby. Your doctor will discuss the risks and benefits of taking temazepam while nursing with you.6

 

Drug Interactions

Temazepam can interact with several other drugs. Before starting temazepam, tell your doctor if you are taking any of the following drugs:

1. Other benzos

All other benzos can add to the side effects of temazepam. You should avoid using them together at all costs.3,7,10

Other benzos include1:

  • Alprazolam (Xanax)
  • Bromazepam (Lectopam)
  • Chlordiazepoxide (Librium)
  • Clonazepam (Klonopin)
  • Clorazepate (Tranxene)
  • Diazepam (Valium)
  • Lorazepam (Ativan)
  • Oxazepam (Serax)

2. Sodium Oxybate (Xyrem)

Your psychiatrist may prescribe this drug if you have extreme daytime sleepiness caused by narcolepsy.11 Sodium oxybate can boost the sedative effects of temazepam to dangerous levels, and vice versa. You should never take this drug when you are taking temazepam.3

3. SSRIs

Selective serotonin reuptake inhibitors (SSRIs) can increase sedation caused by temazepam if they are taken together for a long time.1

Examples of SSRIs include11:

  • Citalopram (Celexa)
  • Escitalopram (Lexapro)
  • Fluoxetine (Prozac)
  • Paroxetine (Paxil)
  • Sertraline (Zoloft)

4. Antidepressants

Tricyclic and tetracyclic antidepressants can also worsen the sedative effects of temazepam.3

Examples of these classes of antidepressants include12:

  • Amitriptyline
  • Amoxapine
  • Desipramine (Norpramin)
  • Doxepin
  • Imipramine (Tofranil)
  • Nortriptyline (Pamelor)
  • Maprotiline
  • Trimipramine (Surmontil)

5. Antipsychotics

Antipsychotics may increase the sedation caused by temazepam as well.3,13 You should be careful when taking antipsychotics and temazepam at the same time.3

Some commonly prescribed antipsychotics include13:

  • Aripiprazole
  • Chlorpromazine
  • Fluphenazine
  • Haloperidol
  • Perphenazine
  • Quetiapine
  • Risperidone

6. Barbiturates

Like benzos, barbiturates are a class of tranquilizers.9 They can add to drowsiness, confusion, and other side effects of temazepam.

Some barbiturates include14:

  • Amobarbital
  • Phenobarbital
  • Secobarbital

7. Antihistamines

Antihistamines can cross the barrier between the blood and brain, leading to sedation.15 This may make the sedation from temazepam worse.

Some antihistamines include15:

  • Cetirizine
  • Clemastine
  • Diphenhydramine
  • Hydroxyzine

8. Alcohol

Alcohol has a major interaction with temazepam. Both alcohol and temazepam decrease brain activity. You may feel drowsy and more fatigued when taking these drugs together. The combination can also increase the risk of abnormal behaviors like sleep-driving.10 The interaction can be lethal if you take too much of either drug.7,10

9. Narcotics

Both temazepam and narcotics (also called “opioids”)have a potential for abuse and addiction. Additionally, both of the drugs can increase the effects of the other. Taking temazepam with a narcotic can lead to extreme sedation or confusion. It can also suppress breathing to dangerously low rates. You should avoid taking them together unless advised by your doctor to do so.10

Examples of narcotics include16:

  • Codeine
  • Hydrocodone (Vicodin)
  • Fentanyl
  • Morphine (Astramorph, Avinza, DepoDur, Duramorph, Kadian)
  • Methadone (Dolophine)
  • Pethidine

 

Comparison of Temazepam to Similar Drugs

Temazepam vs. Xanax (Alprazolam)

Insomnia vs. Anxiety

Temazepam is an effective sleeping pill, but has little effect on anxiety symptoms.8,10 In contrast, alprazolam is effective at easing anxiety but is not that helpful for treating insomnia symptoms.8,17

Onset of Action

Temazepam takes about an hour to start working.8,10  Alprazolam starts to kick in more quickly.8,17

Duration of Action

The effects of both temazepam and alprazolam tend to wear off in around 10 to 20 hours.8,10,17

Toxicity

Although temazepam can be dangerous if taken in high doses, it is less likely to be fatal than high doses of alprazolam. Research shows that alprazolam is most likely of all benzos to be lethal if taken at high doses.7

Temazepam vs. Lorazepam

Available forms

Temazepam is only available in a capsule form. Lorazepam is available as a pill, a dissolving tablet and an injection.1

Onset of Action

Lorazepam takes longer to kick in than an equivalent dose of temazepam.1,8

Major uses

Lorazepam benefits anxiety more than insomnia. This is in contrast to temazepam, which is a stronger sleeping aid than anti-anxiety drug.10,18

Drug interactions

You are less likely to have drug interactions with lorazepam than temazepam.1

Withdrawal symptoms

The withdrawal symptoms experienced with temazepam are less intense than those experienced with lorazepam.8,10,18

Temazepam vs. Diazepam (Valium)

Available forms

Temazepam is only available in a capsule form. Diazepam is available as a tablet, injection and suppository.1,8,10,19

Onset and Duration of Action

Diazepam’s effects are seen more quickly after taking it than temazepam. The effects of diazepam last longer than temazepam, though, usually between 1 and 3 days.1,8

Breakdown of Drug in the Body

The liver breaks down diazepam into other compounds, which continue to produce effects on the body. Temazepam has no active metabolites.1

Uses

In contrast to temazepam, diazepam may be useful in treating panic attacks, alcohol withdrawal, fits and muscle spasms.1

Temazepam vs. Clonazepam (Klonopin)

Onset and Duration of action

Clonazepam’s sedative effects take longer to kick in than temazepam’s, but they usually last longer.1,8

               Uses

Your doctor is more likely to prescribe clonazepam to treat anxiety or panic attacks than temazepam.1,8,10,20

Temazepam vs. Zolpidem (Ambien)

Mechanism of Action

Though it belongs to a different class of drugs and has a different structure, zolpidem works the same way as temazepam. It increases the effects of GABA in the brain.8,10,21

Onset and Duration of Action

The hypnotic effects of zolpidem begin more quickly than those of temazepam, but they do not last as long.8,10,21

Safety during Pregnancy

Zolpidem may be safer during pregnancy than temazepam. The FDA classifies zolpidem as a “pregnancy Category C” drug. 21 This means that studies in animals showed side effects in the unborn baby when the mother was given zolpidem, but these effects have not been confirmed in humans.5 This is in contrast to temazepam, which has been proven unsafe for unborn human babies.5,10

Risk for abuse

Zolpidem has a lower potential for abuse and withdrawal than temazepam. You are also less likely to develop tolerance to zolpidem. This means you are less likely to have to increase your dosage over time.8

 

Abuse of Temazepam10

Temazepam is a controlled substance with the potential for abuse and addiction.

Abuse of temazepam includes any use of this drug not specifically ordered by a doctor. This includes:

  • taking higher doses of temazepam than prescribed
  • taking doses more frequently than prescribed
  • taking temazepam that was prescribed for someone else

Temazepam abuse increases your risk of becoming physically dependent on it.  Long-term abuse may cause you to be unable to fall asleep without taking temazepam. You may also become unable to function normally during the day without taking temazepam.

Physical dependence can lead to mental or emotional dependence (addiction). It can cause you to have a compulsive desire to take the drug, even though you know  that it is harmful for your health.

In addition to the health-related side effects associated with misuse, temazepam abuse can lead to:

  • Failure to meet your responsibilities at work, school, or home
  • Increased engagement in dangerous activities (e.g. driving under the effects of the drug can lead to accidents)
  • Decreases in the quality of your relationships and social life

If you develop a dependency on temazepam, you may experience withdrawal symptoms if you try to stop taking it. These symptoms may include:

  • Worsening of insomnia
  • Severe headaches
  • Becoming easily angry or agitated
  • Acting aggresively
  • New or worsening anxiety
  • Panic attacks
  • Problems remembering information or past events
  • A decrease in your ability to focus
  • A decrease in your ability to recognize danger
  • Shaking
  • Feelings of pins and needles on your skin
  • Seizures
  • Coma (which is rare, but can result in death)

 

Temazepam Overdose

Overdosing on temazepam can have serious consequences, including difficulty breathing and depressed brain function. Temazepam overdose can lead to coma and death. An overdose is more likely to be fatal if the temazepam was taken along with another sedative or tranquilizer.

 

Temazepam FAQs

  1. Is temazepam a good sleeping pill?

Temazepam is one of the strongest sleeping pills on the market. It gives you a full night’s sleep. However, its side effects limit its use for long periods of time.10

  1. Is temazepam a benzodiazepine?

Yes, temazepam is a benzodiazepine.1

  1. Is temazepam a barbiturate?

No, temazepam is not a barbiturate. Temazepam is a benzodiazepine.1 This is a different class of drugs.

  1. I took temazepam while pregnant. Should I take temazepam while pregnant?

No, you should avoid taking temazepam when you are pregnant. The US FDA classifies temazepam as a pregnancy category X drug.3 This means that tests have shown that it can cause birth defects in unborn animal and human babies.5 Studies have also shown that taking temazepam when you are pregnant can cause withdrawal symptoms in the baby after birth.6

If you are taking temazepam and believe you may be pregnant, or know that you are pregnant, please call your doctor at once.

  1. Can you overdose on temazepam? How many temazepam can you take safely?

Yes, you can overdose on temazepam. Taking too much temazepam can cause you to fall into a coma. In some cases, large doses of temazepam can be fatal.9,10 The maximum recommended safe dose of temazepam is 30 mg per day. That equates to between 1 and 4 temazepam pills, depending on their strength.10

An overdose is more likely to be fatal if temazepam is taken with alcohol or another sedative.10

  1. Why is temazepam a controlled substance?

Temazepam is a controlled substance  because it has a strong potential for abuse. It may cause physical, mental and emotional dependence.10

  1. Is temazepam a narcotic?

No, temazepam is not a narcotic. It is a benzodiazepine. This is a different class of drugs.1

 

References

  1. Griffin CE, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine Pharmacology and Central Nervous System–Mediated Effects. The Ochsner Journal. 2013;13(2):214-223. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3684331. Accessed June 20, 2017.
  2. Erman MK, Loewy D, Scharf MB. Comparison of temazepam 7.5 mg with temazepam 15 mg for the treatment of transient insomnia. Curr Med Res Opin. 2004;20(4):441-9. https://www.ncbi.nlm.nih.gov/pubmed/15119980. Accessed June 20, 2017.
  3. Medscape. Temazepam (Rx). http://reference.medscape.com/drug/restoril-temazepam-342911#4. Accessed June 21, 2017.
  4. Rodriguez-Roisin R, Garcia-Aymerich J. Should we exercise caution with benzodiazepine use in patients with COPD? European Respiratory Journal. 2014;44(2):284-6. doi: 10.1183/09031936.00071014.
  5. Chemical Hazards Emergency Medical Management. FDA Pregnancy Categories. https://chemm.nlm.nih.gov/pregnancycategories.htm. Accessed June 21, 2017.
  6. Lebedevs TH, Wojnar-Horton RE, Yapp P, et al. Excretion of temazepam in breast milk. British Journal of Clinical Pharmacology. 1992;33(2):204-206. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1381312/. Accessed June 20, 2017.
  7. Isbister GK, O’Regan L, Sibbritt D, Whyte IM. Alprazolam is relatively more toxic than other benzodiazepines in overdose. British Journal of Clinical Pharmacology. 2004;58(1):88-95. doi: 10.1111/j.1365-2125.2004.02089.x.
  8. Procyshyn RM, Bezchlibnyk-Butler KZ, Jeffries JJ. Anxiolytics (Antianxiety) agents. In: Bezchlibnyk-Butler KZ, Jeffries JJ. Clinical Handbook of Psychotropic Drugs. 21st Ed. Toronto, Ontario, Canada: Hogrefe Inc; 2015:196-204.
  9. 9. Buckley NA, Dawson AH, Whyte IM, O’Connell DL. Relative toxicity of benzodiazepines in overdose. BMJ. 1995 Jan;310(6974):219-21. Doi: 10.1136/bmj.310.6974.219.
  10. Mallinckrodt Pharmaceuticals. Restoril (temazepam). 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf. Accessed October 6, 2017.
  11. Mayo Clinic. Selective serotonin reuptake inhibitors (SSIs). Last updated June 24, 2016. http://www.mayoclinic.org/diseases-conditions/depression/in-depth/ssris/art-20044825?pg=2. Accessed October 6, 2017.
  12. Mayo Clinic. Tricyclic antidepressants and tetracyclic antidepressants. Last updated June 28, 2016. http://www.mayoclinic.org/diseases-conditions/depression/in-depth/antidepressants/art-20046983. Accessed October 6, 2017.
  13. National Institute of Mental Health. Mental Health Medications. Last updated October 2016. https://www.nimh.nih.gov/health/topics/mental-health-medications/index.shtml#part_149866. Accessed October 6, 2017.
  14. Mayo Clinic. Barbiturate (oral route, parenteral route, rectal route). Last updated March 1, 2017. http://www.mayoclinic.org/drugs-supplements/barbiturate-oral-route-parenteral-route-rectal-route/proper-use/drg-20069290. Accessed October 7, 2017.
  15. Mayo Clinic. Antihistamine (oral route, parenteral route, rectal route). Last updated March 1, 2017. http://www.mayoclinic.org/drugs-supplements/antihistamine-oral-route-parenteral-route-rectal-route/proper-use/drg-20070373. Accessed October 7, 2017.
  16. Smith HS. Opioid Metabolism. Mayo Clin Proc. 2009;84(7):613-624. Doi: 10.1016/S0025-6196(11)60750-7.
  17. Pfizer. Xanax (alprazolam tablets). Last updated March 2011. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.pdf. Accessed October 7, 2017.
  18. Valeant Pharmaceuticals International, Inc. Atvian (lorazepam) tablets. Last updated September, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf. Accessed October 7, 2017.
  19. Roche. Valium brand of diazepam tablets. Last updated January 2008. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf. Accessed October 7, 2017.
  20. Genentech USA, Inc. Klonopin tablets (clonazepam). Last updated October 2013. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf. Accessed October 7, 2017.
  21. Sanofi-aventis. Ambien (zolpidem tartrate) tablets prescribing information. Last updated February, 2008. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf. Accessed October 7, 2017.

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