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Restoril

  • Generic Name: temazepam
  • Brand Name: Restoril
Last reviewed on RxList: 8/23/2018

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Restoril(Temazepam) side effects drug center

Restoril Side Effects Center

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Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/23/2018

Restoril ( temazepam ) is a benzodiazepine sedative hypnotic used to treat insomnia symptoms, such as trouble falling or staying asleep. Restoril is available in generic form. Common side effects of Restoril include:

  • dizziness
  • daytime drowsiness (or during hours when you are not normally sleeping)
  • amnesia or forgetfulness
  • muscle weakness
  • loss of balance or coordination
  • headache
  • blurred vision
  • depression
  • nervousness
  • excitability
  • irritability
  • nausea
  • vomiting
  • stomach discomfort
  • dry mouth
  • increased thirst , or
  • numbness
  • burning
  • pain, or
  • tingly feeling

Tell your doctor if you experience serious side effects of Restoril including weak or shallow breathing, fast or pounding heartbeats, confusion , slurred speech, unusual thoughts or behavior, hallucinations , agitation, aggression, thoughts of suicide or hurting yourself, restless muscle movements (in your eyes, tongue, jaw, or neck), pale skin , easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms, problems with urination, stomach pain, low fever, loss of appetite , dark urine , clay-colored stools, or jaundice (yellowing of the skin or eyes).

The usual recommended usual adult dose of Restoril is 15 mg before retiring, though 7.5 mg may be sufficient for some patients, and others may need 30 mg. Restoril may interact with fluvoxamine, itraconazole, ketoconazole , nefazodone, or other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). Tell your doctor all medication you use. Restoril must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy, and have also caused unusual drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used for a long time during pregnancy. Use birth control while taking this drug. This medication passes into breast milk. Consult your doctor before breast-feeding. Withdrawal symptoms (such as unusual depressed/anxious mood, stomach/ muscle cramps , vomiting, sweating, shakiness, seizures) may occur if you suddenly stop using this medication.

Our Restoril (temazepam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Restoril Consumer Information

Temazepam may cause a severe allergic reaction. Stop taking temazepam and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking temazepam and talk with your doctor about another treatment for your sleep disorder.

Call your doctor at once if you have:

  • confusion, agitation, hostility, hallucinations;
  • anxiety, memory problems;
  • depressed mood; or
  • thoughts of suicide or hurting yourself.

Common side effects may include:

  • day-time drowsiness or “hangover” feeling;
  • headache;
  • dizziness, tiredness;
  • nausea; or
  • feeling nervous.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Restoril (Temazepam)

Learn More »

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Restoril Professional Information

SIDE EFFECTS

During controlled clinical studies in which 1076 patients
received Restoril at bedtime, the drug was well tolerated. Side effects were
usually mild and transient. Adverse reactions occurring in 1% or more of
patients are presented in the following table:

 Restoril
% Incidence
(n=1076)
Placebo
% Incidence
(n=783)
Drowsiness9.15.6
Headache8.59.1
Fatigue4.84.7
Nervousness4.68.2
Lethargy4.53.4
Dizziness4.53.3
Nausea3.13.8
Hangover2.51.1
Anxiety2.01.5
Depression1.71.8
Dry Mouth1.72.2
Diarrhea1.71.1
Abdominal Discomfort1.51.9
Euphoria1.50.4
Weakness1.40.9
Confusion1.30.5
Blurred Vision1.31.3
Nightmares1.21.7
Vertigo1.20.8

The following adverse events have been reported less
frequently (0.5% to 0.9%):

Central Nervous System – anorexia , ataxia ,
equilibrium loss, tremor , increased dreaming

Cardiovascular – dyspnea , palpitations

Gastrointestinal – vomiting

Musculoskeletal – backache

Special Senses – hyperhidrosis , burning eyes

Amnesia , hallucinations, horizontal nystagmus, and
paradoxical reactions including restlessness, overstimulation and agitation
were rare (less than 0.5%).

Drug Abuse And Dependence

Abuse and addiction are separate and distinct from
physical dependence and tolerance . Abuse is characterized by misuse of the drug
for non-medical purposes, often in combination with other psychoactive
substances. Physical dependence is a state of adaptation that is manifested by
a specific withdrawal syndrome that can be produced by abrupt cessation, rapid
dose reduction, decreasing blood level of the drug and/or administration of an
antagonist . Tolerance is a state of adaptation in which exposure to a drug
induces changes that result in a diminution of one or more of the drug’s effects
over time. Tolerance may occur to both the desired and undesired effects of
drugs and may develop at different rates for different effects.

Addiction is a primary , chronic , neurobiological disease
with genetic , psychosocial, and environmental factors influencing its
development and manifestations. It is characterized by behaviors that include
one or more of the following: impaired control over drug use, compulsive use,
continued use despite harm, and craving. Drug addiction is a treatable disease,
utilizing a multidisciplinary approach, but relapse is common.

Controlled Substance

Restoril is a controlled substance in Schedule IV.

Abuse And Dependence

Withdrawal symptoms , similar in character to those noted
with barbiturates and alcohol (convulsions, tremor, abdominal , and muscle
cramps, vomiting, and sweating ), have occurred following abrupt discontinuance
of benzodiazepines . The more severe withdrawal symptoms have usually been
limited to those patients who received excessive doses over an extended period
of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia )
have been reported following abrupt discontinuance of benzodiazepines taken
continuously at therapeutic levels for several months. Consequently, after
extended therapy at doses higher than 15 mg, abrupt discontinuation should
generally be avoided and a gradual dosage tapering schedule followed. As with
any hypnotic, caution must be exercised in administering Restoril to individuals
known to be addiction- prone or to those whose history suggests they may increase
the dosage on their own initiative. It is desirable to limit repeated
prescriptions without adequate medical supervision.

Read the entire FDA prescribing information for Restoril (Temazepam)

Read More »

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Related Resources for Restoril

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Read the Restoril User Reviews »

© Restoril Patient Information is supplied by Cerner Multum, Inc. and Restoril Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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Restoril Drug Imprint

002282076_PB

capsule, green/white, imprinted with R076

002282077_PB

capsule, white, imprinted with R-077, R-077

003783110_PB

capsule, orange/white, imprinted with MYLAN 3110, MYLAN 3110

003784010_PB

capsule, orange, imprinted with MYLAN 4010, MYLAN 4010

003785050_PB

capsule, yellow, imprinted with MYLAN 5050, MYLAN 5050

004069914_PB

capsule, blue, imprinted with FOR SLEEP M, M RESTORIL 22.5 mg

004069915_PB

capsule, blue/pink, imprinted with RESTORIL 7.5 mg, M FOR SLEEP

004069959_PB

capsule, blue, imprinted with 22.5 mg 22.5 mg, M FOR SLEEP

007812201_PB

capsule, green/white, imprinted with GG 531, GG 531

007812202_PB

capsule, white, imprinted with GG 532, GG 532

534890648_PB

capsule, turquoise/white, imprinted with MUTUAL 866, MUTUAL 866

675440038_PB

capsule, green/white, imprinted with GG 531, GG 531

675440136_PB

capsule, green/white, imprinted with R-076, R-076

675440373_PB

capsule, white, imprinted with GG 532, GG 532

678770147_PB

capsule, white, imprinted with 30 mg, Novel 123

Restoril 15 mg

capsule, peach/red, imprinted with RESTORIL 15 MG, FOR SLEEP

Restoril 30 mg

capsule, red/turquoise, imprinted with RESTORIL 30 mg, FOR SLEEP

Temazepam 15 mg-MYL

capsule, orange, imprinted with MYLAN 4010, MYLAN 4010

Temazepam 30 mg-MYL

capsule, yellow, imprinted with MYLAN 5050, MYLAN 5050

Temazepam 30 mg-PUR

capsule, white, imprinted with R-077, R-077

Temazepam 7.5 mg-GG

capsule, peach/white, imprinted with TEMAZEPAM 7.5 mg, 271 cp

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    Prosom
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Restoril User Reviews

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