Medicine guide

Temazepam

30 mg · Capsule

Prescription only
Controlled substance · CIV
Benzodiazepine

Active substance: Temazepam
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: Amneal Pharmaceuticals of New York LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-02-16

What it is

Benzodiazepine

Used for

Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days).

The label’s usual adult dose

While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg.

Full directions ↓

Serious warning

Risks from concomitant use with opioids;

All warnings ↓

Good to know

Prescription only
Controlled substance (schedule IV) — extra rules apply to prescribing and refills
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

60other products contain Temazepam — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days).
For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days).
The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

From the official label · 2024-02-16 · DailyMed

How it works

From this product’s own US prescribing label.

In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using 3 H labeled drug, temazepam was well absorbed and found to have minimal (8%) first pass metabolism.
There were no active metabolites formed and the only significant metabolite present in blood was the O-conjugate.

Half-life0.4–0.6 h

Mostly cleared after≈ 2.5 hfive half-lives — our arithmetic

How the body breaks it down

Temazepam was completely metabolized through conjugation prior to excretion; 80% to 90% of the dose appeared in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-02-16

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

RISKS FROM CONCOMITANT USE WITH OPIOIDS;
ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation ( see WARNINGS and PRECAUTIONS ).
The use of benzodiazepines, including temazepam, 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 temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( see WARNINGS ).
The continued use of benzodiazepines, including temazepam, 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 temazepam 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 temazepam or reduce the dosage ( see DOSAGE AND ADMINISTRATION and WARNINGS ).

Quoted from the official label, section “Boxed Warning”.

How to take it

These directions are for this exact strength and form. Another one is different.

While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg.
In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency.
In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.
Discontinuation or Dosage Reduction of Temazepam To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level.
Subsequently decrease the dosage more slowly ( see WARNINGS, Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE:
Dependence ).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam, and opioids may result in profound sedation, respiratory depression, coma, and death.
Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe temazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
In patients already receiving an opioid analgesic, prescribe a lower initial dose of temazepam than indicated in the absence of an opioid and titrate based on clinical response.
If an opioid is initiated in a patient already taking temazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when temazepam is used with opioids.
Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined ( see PRECAUTIONS, Drug Interactions ).
Abuse, Misuse, and Addiction The use of benzodiazepines, including temazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death ( see DRUG ABUSE AND DEPENDENCE, Abuse ).
Before prescribing temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).
Use of temazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of temazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction.
Prescribe the lowest effective dosage;
avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug.
If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.
Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) ( see DOSAGE AND ADMINISTRATION, Discontinuation or Dosage Reduction of Temazepam ).
Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.
Acute Withdrawal Reactions The continued use of benzodiazepines, including temazepam, may lead to clinically significant physical dependence.
Abrupt discontinuation or rapid dosage reduction of temazepam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) ( see DRUG ABUSE AND DEPENDENCE, Dependence ) .
Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months ( see DRUG ABUSE AND DEPENDENCE, Dependence ).
Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated.
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
Worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior.
Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class.
Because some of the worrisome adverse effects of benzodiazepines, including temazepam, appear to be dose related ( see PRECAUTIONS and DOSAGE AND ADMINISTRATION ), it is important to use the lowest possible effective dose.
Elderly patients are especially at risk.
Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol.
Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization.
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported.
These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons.
Although behaviors such as “sleep-driving” may occur with temazepam alone at therapeutic doses, the use of alcohol and other CNS depressants with temazepam appears to increase the risk of such behaviors, as does the use of temazepam at doses exceeding the maximum recommended dose.
Due to the risk to the patient and the community, discontinuation of temazepam should be strongly considered for patients who report a “sleep-driving” episode.
Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
As with “sleep-driving”, patients usually do not remember these events.
Amnesia and other neuro-psychiatric symptoms may occur unpredictably.
In primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Because temazepam can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.
Severe Anaphylactic and Anaphylactoid Reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam.
Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.
Some patients have required medical therapy in the emergency department.
If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Patients who develop angioedema after treatment with temazepam should not be rechallenged with the drug.
Neonatal Sedation and Withdrawal Syndrome Use of temazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate ( see PRECAUTIONS, Pregnancy ) .
Monitor neonates exposed to temazepam during pregnancy or labor for signs of sedation and monitor neonates exposed to temazepam during pregnancy for signs of withdrawal; manage these neonates accordingly.
General Since the risk of the development of oversedation, dizziness, confusion, and/or ataxia increases substantially with larger doses of benzodiazepines in elderly and debilitated patients, 7.5 mg of temazepam is recommended as the initial dosage for such patients.
Temazepam should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression; it should be recognized that suicidal tendencies may be present and protective measures may be necessary.
The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency.
If temazepam is to be combined with other drugs having known hypnotic properties or CNS-depressant effects, consideration should be given to potential additive effects.
The possibility of a synergistic effect exists with the co-administration of temazepam and diphenhydramine.
One case of stillbirth at term has been reported 8 hours after a pregnant patient received temazepam and diphenhydramine.
A cause and effect relationship has not yet been determined ( see CONTRAINDICATIONS ).
Information for Patients Advise the patient to read the FDA approved patient labeling (Medication Guide).
Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when temazepam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider.
Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined ( see WARNINGS, Risks from Concomitant Use with Opioids and PRECAUTIONS, Drug Interactions ).
Abuse, Misuse, and Addiction Inform patients that the use of temazepam, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances.
Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug ( see WARNINGS, Abuse, Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE ).
Withdrawal Reactions Inform patients that the continued use of temazepam may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of temazepam may precipitate acute withdrawal reactions, which can be life-threatening.
Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.
Instruct patients that discontinuation or dosage reduction of temazepam may require a slow taper ( see WARNINGS, Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE ). “Sleep-Driving” and Other Complex Behaviors There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event.
If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous.
This behavior is more likely to occur when temazepam is taken with alcohol or other central nervous system depressants ( see WARNINGS ).
Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
As with “sleep-driving”, patients usually do not remember these events.
Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.
Pregnancy Advise pregnant females that use of temazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns ( see WARNINGS, Neonatal Sedation and Withdrawal Syndrome and PRECAUTIONS, Pregnancy ).
Instruct patients to inform their healthcare provider if they are pregnant.
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to temazepam during pregnancy ( see PRECAUTIONS, Pregnancy ).
Nursing Instruct patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed.
Instruct breastfeeding patients using temazepam to monitor infants for excessive sedation, poor feeding and poor weight gain, and to seek medical attention if they notice these signs ( see PRECAUTIONS , Nursing Mothers ).
Laboratory Tests The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency.
Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines.
Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors.
When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
The benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.
The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.
Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies were conducted in rats at dietary temazepam doses up to 160 mg/kg/day for 24 months and in mice at dietary doses of 160 mg/kg/day for 18 months.
No evidence of carcinogenicity was observed although hyperplastic liver nodules were observed in female mice exposed to the highest dose.
The clinical significance of this finding is not known.
Fertility in male and female rats was not adversely affected by temazepam.
No mutagenicity tests have been done with temazepam.
Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including temazepam, during pregnancy.
Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/.
Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal ( see WARNINGS, Neonatal Sedation and Withdrawal Syndrome and Clinical Considerations ) .
Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates.
Monitor neonates exposed to temazepam during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems.
Monitor neonates exposed to temazepam during pregnancy for signs of withdrawal.
Manage these neonates accordingly ( see WARNINGS, Neonatal Sedation and Withdrawal Syndrome ) .
Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects.
Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted.
In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings.
Animal Data Reproduction studies in animals with temazepam were performed in rats and rabbits.
In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality.
Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher.
In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship.
Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls.
At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls.
Nursing Mothers Risk Summary Temazepam is present in breast milk.
There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk.
The effects of temazepam on milk production are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for temazepam and any potential adverse effects on the breastfed infant from temazepam or from the underlying maternal condition.
Clinical Considerations Infants exposed to temazepam through breast milk should be monitored for sedation, poor feeding and poor weight gain.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric Use Clinical studies of temazepam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in response between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy commonly observed in this population.
Temazepam 7.5 mg is recommended as the initial dosage for patients aged 65 and over since the risk of the development of oversedation, dizziness, confusion, ataxia and/or falls increases substantially with larger doses of benzodiazepines in elderly and debilitated patients.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma.
In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia.
Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur.
In severe overdosage cases, patients may develop respiratory depression and coma.
Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal ( see WARNINGS, Abuse, Misuse, and Addiction ).
Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.
In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.
Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency.
The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy.
Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus).
If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage.
See the flumazenil injection Prescribing Information.
Consider contacting the Poison Help line (1-800-222-12222) or a medical toxicologist for additional overdosage management recommendations.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Controlled Substance Temazepam capsules contain temazepam , a Schedule IV controlled substance.
Abuse Temazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction.
Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication.
Abuse and misuse of benzodiazepines may lead to addiction.
Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.
Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders ( see WARNINGS, Abuse, Misuse, and Addiction ).
The following adverse reactions have occurred with benzodiazepine abuse and/or misuse:
abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.
The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse:
delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death.
Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).
Dependence Physical Dependence Temazepam may produce physical dependence from continued therapy.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening.
Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use ( see WARNINGS, Dependence and Withdrawal Reactions ).
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage ( see DOSAGE AND ADMINISTRATION, Discontinuation or Dosage Reduction of Temazepam and WARNINGS, Dependence and Withdrawal Reactions ).
Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor.
More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality.
Protracted Withdrawal Syndrome Protracted withdrawal syndrome with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal.
Protracted withdrawal symptoms may last weeks to more than 12 months.
As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.
Tolerance Tolerance to temazepam may develop from continued therapy.
Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
Tolerance to the therapeutic effect of temazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Quoted from the official label, section “Drug Abuse and Dependence”.

Side effects

During controlled clinical studies in which 1,076 patients received temazepam 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:
Temazepam % Incidence (n=1,076) Placebo % Incidence (n=783) Drowsiness 9.1
5.6 Headache 8.5
9.1 Fatigue 4.8
4.7 Nervousness 4.6
8.2 Lethargy 4.5
3.4 Dizziness 4.5
3.3 Nausea 3.1
3.8 Hangover 2.5
1.1 Anxiety 2.0
1.5 Depression 1.7
1.8 Dry Mouth 1.7
2.2 Diarrhea 1.7
1.1 Abdominal Discomfort 1.5
1.9 Euphoria 1.5
0.4 Weakness 1.4
0.9 Confusion 1.3
0.5 Blurred Vision 1.3
1.3 Nightmares 1.2
1.7 Vertigo 1.2
0.8 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%).
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

Temazepam capsules, USP 15 mg are hard gelatin capsules with white opaque body printed radially “556” with black ink and blue green opaque cap printed radially “AMNEAL” with black ink.
They are available as follows:
Bottles of 100:
NDC 53746-556-01 Bottles of 500:
NDC 53746-556-05 Temazepam capsules, USP 30 mg are hard gelatin capsules with white opaque body printed radially “557” with black ink and white opaque cap printed radially “AMNEAL” with black ink.
They are available as follows:
Bottles of 100:
NDC 53746-557-01 Bottles of 500:
NDC 53746-557-05 Dispense in a well-closed, light-resistant container with a child-resistant closure.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Manufactured by: Amneal Pharmaceuticals Pvt.
Ltd.
Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by:
Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 03-2023-00 Dispense with Medication Guide available at:
documents.amneal.com/mg/temazepamcapsules.pdf

Quoted from the official label, section “How Supplied”.

What is in it

Temazepam, USP is a benzodiazepine hypnotic agent.
The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:
C 16 H 13 ClN 2 O 2 MW =
300.74 Temazepam, USP is a white or almost white crystalline powder, very slightly soluble in water and sparingly soluble in alcohol USP.
Temazepam capsules USP, 15 mg and 30 mg, are for oral administration.
Each capsule for oral administration contains either 15 mg or 30 mg temazepam, USP.
The inactive ingredients include:
ammonia, black iron oxide, butyl alcohol, croscarmellose sodium, dehydrated alcohol, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, and titanium dioxide.
Additionally, the 15 mg capsule contains FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6. 1

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
Colour dyesthe 15 mg capsule contains FD&C Blue #1; FD&C Red #40; FD&C Yellow #6. 1Some people react to dyes such as tartrazine (Yellow 5) or carmine.
Alcohol (ethanol)butyl alcohol; dehydrated alcoholMatters for children, in pregnancy, in recovery and with some medicines.
GelatingelatinAnimal-derived: matters for vegetarian, vegan, halal and kosher diets.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (20)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 20 of 20

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Canada5 matching products

Every strength and form (10)

NetherlandsNo exact match for this strength and form

Every strength and form (6)

Details

Made by	Amneal Pharmaceuticals of New York LLC
Active substance	Temazepam
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	30 mg
Form	Capsule
Route	Oral
Packs	100 CAPSULE in 1 BOTTLE · 500 CAPSULE in 1 BOTTLE
NDC	53746-557

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

57 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Capsule57 products
- 7.5 mg11
  7.5 mg · 11 companies
  +3 more
- 15 mg19
  15 mg · 19 companies
  +11 more
- 22.5 mg8
  22.5 mg · 8 companies
- 30 mg19
  30 mg · 19 companies
  - A-S Medication Solutions
  - Actavis Pharma, Inc.
  - Advanced Rx Pharmacy of Tennessee, LLC
  - Alembic Pharmaceuticals Inc.
  - Alembic Pharmaceuticals Limited
  - Amneal Pharmaceuticals LLC
  - Amneal Pharmaceuticals of New York LLC · this page
  - Aphena Pharma Solutions - Tennessee, LLC
  +11 more

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Restoril22.5 mgPrescription onlyCapsule SpecGx LLC · Temazepam Restoril7.5 mgPrescription onlyCapsule SpecGx LLC · Temazepam Restoril15 mgPrescription onlyCapsule SpecGx LLC · Temazepam Restoril30 mgPrescription onlyCapsule SpecGx LLC · Temazepam Temazepam15 mgPrescription onlyCapsule Actavis Pharma, Inc. · Temazepam Temazepam30 mgPrescription onlyCapsule Actavis Pharma, Inc. · Temazepam

See every product with Temazepam