Label: TEMAZEPAM capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 5, 2024

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  • temazepam 7.5mg-header

    temazepam 7.5mg-header

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  • DESCRIPTION

    Temazepam 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:


    temazepam-str

    C 16H 13ClN 2O 2 MW = 300.74



    Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP.

    Temazepam Capsules, USP 7.5 mg, are for oral administration.



    7.5 mg Capsules

    Active Ingredient: temazepam USP



    7.5 mg Capsules

    Inactive Ingredients:
    Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide.

    May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.

  • CLINICAL PHARMACOLOGY

    Pharmacokinetics

    In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using 3H 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. The unchanged drug was 96% bound to plasma proteins. The blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the terminal half-life from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study population and method of determination. Metabolites were formed with a half-life of 10 hours and excreted with a half-life of approximately 2 hours. Thus, formation of the major metabolite is the rate limiting step in the biodisposition of Temazepam. There is no accumulation of metabolites. A dose-proportional relationship has been established for the area under the plasma concentration/time curve over the 15 to 30 mg dose range.

    Temazepam was completely metabolized through conjugation prior to excretion; 80% to 90% of the dose appeared in the urine. The major metabolite was the O-conjugate of temazepam (90%); the O-conjugate of N-desmethyl temazepam was a minor metabolite (7%).

    Bioavailability, Induction, and Plasma Levels

    Following ingestion of a 30 mg Temazepam capsule, measurable plasma concentrations were achieved 10 to 20 minutes after dosing with peak plasma levels ranging from 666 to 982 ng/mL (mean 865 ng/mL) occurring approximately 1.2 to 1.6 hours (mean 1.5 hours) after dosing.

    In a 7 day study, in which subjects were given a 30 mg Temazepam capsule 1 hour before retiring, steady-state (as measured by the attainment of maximal trough concentrations) was achieved by the third dose. Mean plasma levels of Temazepam (for days 2 to 7) were 260±210 ng/mL at 9 hours and 75±80 ng/mL at 24 hours after dosing. A slight trend toward declining 24 hour plasma levels was seen after day 4 in the study, however, the 24 hour plasma levels were quite variable.

    At a dose of 30 mg once-a-day for 8 weeks, no evidence of enzyme induction was found in man.

    Elimination Rate of Benzodiazepine Hypnotics and Profile of Common Untoward Effects

    The type and duration of hypnotic effects and the profile of unwanted effects during administration of benzodiazepine hypnotics may be influenced by the biologic half-life of the administered drug and for some hypnotics, the half-life of any active metabolites formed. Benzodiazepine hypnotics have a spectrum of half-lives from short (<4 hours) to long (>20 hours). When half-lives are long, drug (and for some drugs their active metabolites) may accumulate during periods of nightly administration and be associated with impairments of cognitive and/or motor performance during waking hours; the possibility of interaction with other psychoactive drugs or alcohol will be enhanced. In contrast, if half-lives are shorter, drug (and, where appropriate, its active metabolites) will be cleared before the next dose is ingested, and carry-over effects related to excessive sedation or CNS depression should be minimal or absent. However, during nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of benzodiazepine hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug, or, if appropriate, its active metabolites (i.e., in relationship to the receptor site) may occur at some point in the interval between each night’s use. This sequence of events may account for 2 clinical findings reported to occur after several weeks of nightly use of rapidly eliminated benzodiazepine hypnotics, namely, increased wakefulness during the last third of the night, and the appearance of increased signs of daytime anxiety.

    Controlled Trials Supporting Efficacy

    Temazepam improved sleep parameters in clinical studies. Residual medication effects (“hangover”) were essentially absent. Early morning awakening, a particular problem in the geriatric patient, was significantly reduced.

    Patients with chronic insomnia were evaluated in 2 week, placebo controlled sleep laboratory studies with temazepam at doses of 7.5 mg, 15 mg, and 30 mg, given 30 minutes prior to bedtime. There was a linear dose-response improvement in total sleep time and sleep latency, with significant drug-placebo differences at 2 weeks occurring only for total sleep time at the 2 higher doses, and for sleep latency only at the highest dose.

    In these sleep laboratory studies, REM sleep was essentially unchanged and slow wave sleep was decreased. No measurable effects on daytime alertness or performance occurred following temazepam treatment or during the withdrawal period, even though a transient sleep disturbance in some sleep parameters was observed following withdrawal of the higher doses. There was no evidence of tolerance development in the sleep laboratory parameters when patients were given temazepam nightly for at least 2 weeks.

    In addition, normal subjects with transient insomnia associated with first night adaptation to the sleep laboratory were evaluated in 24 hour, placebo controlled sleep laboratory studies with temazepam at doses of 7.5 mg, 15 mg, and 30 mg, given 30 minutes prior to bedtime. There was a linear dose-response improvement in total sleep time, sleep latency and number of awakenings, with significant drug-placebo differences occurring for sleep latency at all doses, for total sleep time at the 2 higher doses and for number of awakenings only at the 30 mg dose.

  • INDICATIONS & USAGE

    Temazepam Capsules, USP 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.

  • 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 ( seePRECAUTIONS,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 ( seePRECAUTIONSandDOSAGE 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 Restoril during pregnancy or labor for signs of sedation and monitor
    neonates exposed to temazepam during pregnancy for signs of withdrawal; manage these neonates accordingly.

  • PRECAUTIONS

    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 ( seeWARNINGS,
    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.


    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

    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 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 patient 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.

  • ADVERSE REACTIONS

    During controlled clinical studies in which 1076 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=1076)
    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%).

  • DRUG ABUSE AND DEPENDENCE

    Controlled Substance

    Temazepam Capsules contains 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.

  • OVERDOSAGE

    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.

  • DOSAGE AND ADMINISTRATION

    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 Capsules


    To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam capsules 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).

  • MEDICATION GUIDE

    MEDICATION GUIDE
    TEMAZEPAM ( tem az’ e pam) Capsules, C-IV

    What is the most important information I should know about
    temazepam?
    • temazepam is a benzodiazepine medicine. Taking
    benzodiazepines with opioid medicines, alcohol, or other central
    nervous system (CNS) depressants (including street drugs) can
    cause severe drowsiness, breathing problems (respiratory
    depression), coma and death.
    Get emergency help right away if any
    of the following happens:
    ° shallow or slowed breathing
    ° breathing stops (which may lead to the heart stopping)
    ° excessive sleepiness (sedation)

    Do not drive or operate heavy machinery until you know how taking
    temazepam and opioids affects you.
    ° Risk of abuse, misuse, and addiction. There is a risk of abuse,
    misuse, and addiction with benzodiazepines including temazepam
    which can lead to overdose and serious side effects including
    coma and death.

    ° Serious side effects including coma and death
    have happened in people who have abused or misused
    benzodiazepines, including temazepam.
    These serious side
    effects may also include delirium, paranoia, suicidal thoughts or
    actions, seizures, and difficulty breathing. Call your healthcare
    provider or go to the nearest hospital emergency room right
    away if you get any of these serious side effects.
    ° You can develop an addiction even if you take temazepam as
    prescribed by your healthcare provider
    ° Take temazepam exactly as your healthcare provider
    prescribed.

    ° Do not share your temazepam with other people.
    ° Keep temazepam in a safe place and away from children.

    Physical dependence and withdrawal reactions. temazepam can
    cause physical dependence and withdrawal reactions.
    ° Do not suddenly stop taking temazepam. Stopping temazepam
    suddenly can cause serious and life-threatening side effects,
    including, unusual movements, responses, or expressions,
    seizures, sudden and severe mental or nervous system changes,
    depression, seeing or hearing things that others do not see or hear,
    an extreme increase in activity or talking, losing touch with reality,
    and suicidal thoughts or actions. Call your healthcare provider or
    go to the nearest hospital emergency room right away if you
    get any of these symptoms.

    ° Some people who suddenly stop benzodiazepines have
    symptoms that can last for several weeks to more than
    12 months
    , including, anxiety, trouble remembering, learning, or
    concentrating, depression, problems sleeping, feeling like insects
    are crawling under your skin, weakness, shaking, muscle
    twitching, burning or prickling feeling in your hands, arms, legs or
    feet, and ringing in your ears.
    ° Physical dependence is not the same as drug addiction. Your
    healthcare provider can tell you more about the differences
    between physical dependence and drug addiction.
    ° Do not take more temazepam than prescribed or take temazepam
    for longer than prescribed.

    • After taking temazepam, you may get up out of bed while not being
    fully awake and do an activity that you do not know you are doing. The
    next morning, you may not remember that you did anything during the
    night. You have a higher chance for doing these activities if you drink
    alcohol or take other medicines that make you sleepy with
    temazepam. Reported activities include:
    ° driving a car (“sleep driving”)
    ° making and eating food
    ° talking on the phone
    ° having sex
    ° sleep-walking
    Call your healthcare provider right away if you find out that you have
    done any of the above activities after taking temazepam.

    What is temazepam?
    • Temazepam is a prescription sleep medicine. Temazepam is used in
    adults for the short-term (usually 7 to 10 days) treatment of a sleep
    problem called insomnia. Symptoms of insomnia include trouble falling
    asleep and waking up often during the night.
    • Temazepam is a federal controlled substance (C-IV) because it
    can be abused or lead to dependence.
    Keep temazepam in a safe
    place to prevent misuse and abuse. Selling or giving away temazepam
    may harm others, and is against the law. Tell your healthcare provider
    if you have ever abused or been dependent on alcohol, prescription
    medicines or street drugs.
    • It is not known if temazepam is safe and effective in children.
    • It is not known if temazepam is safe and effective for use longer than
    2 weeks

    Do not take temazepam if you:
    • are allergic to temazepam or any of the ingredients in temazepam
    capsules. See the end of this Medication Guide for a complete list of
    ingredients in temazepam capsules.

    Before you take temazepam, tell your healthcare provider about all of
    your medical conditions, including if you:

    • have a history of depression, mental illness or, suicidal thoughts
    • have a history of drug or alcohol abuse or addiction
    • have lung disease or breathing problems
    • are pregnant or plan to become pregnant.
    • Taking temazepam late in pregnancy may cause your baby to have
    symptoms of sedation (breathing problems, sluggishness, low muscle
    tone), and/or withdrawal symptoms (jitteriness, irritability,
    restlessness, shaking, excessive crying, feeding problems)

    • Tell your healthcare provider right away if you become pregnant or
    think you are pregnant during treatment with temazepam.

    • are breastfeeding, or plan to breastfeed. temazepam can pass through
    your breast milk.

    • Breastfeeding during treatment with temazepam may cause your baby
    to have sleepiness, feeding problems, and decreased weight gain.

    • Talk to your healthcare provider about the best way to feed your baby if
    you take temazepam.


    Tell your healthcare provider about all of the medicines you take,
    including prescription and over-the-counter medicines, vitamins, and
    herbal supplements.

    Taking temazepam with certain other medicines can cause side effects or
    affect how well temazepam or the other medicines work. Do not start or
    stop other medicines without talking to your healthcare provider.
    Do not take temazepam with other medicines that can make you sleepy
    unless your healthcare provider tells you to.
    How should I take temazepam?
    • See “What is the most important information I should know about
    temazepam?”

    • Take temazepam exactly as your healthcare providers tell you to take
    it. Take temazepam right before you get into bed.
    • Do not take temazepam unless you are able to get a full night’s sleep
    before you must be active again.
    • If you take too much temazepam or overdose, get emergency
    treatment right away.

    What are the possible side effects of temazepam?
    Temazepam may cause serious side effects, including:
    • See “What is the most important information I should know about
    temazepam?”
    • Abnormal thoughts and behavior.
    Symptoms include more outgoing
    or aggressive behavior than normal, confusion, agitation,
    hallucinations, worsening of depression, and suicidal thoughts.
    Severe allergic reactions. Symptoms include swelling of the tongue
    or throat, trouble breathing, and nausea and vomiting. Get emergency
    medical help right away if you have these symptoms after taking
    temazepam.
    Temazepam can make you sleepy or dizzy and can slow your thinking
    and motor skills.

    ° Do not drive, operate heavy machinery, or do other dangerous
    activities until you know how temazepam affects you.
    ° Do not drink alcohol or take other drugs that may make you
    sleepy or dizzy while taking temazepam talking to your
    healthcare provider
    . When taken with alcohol or other drugs that
    cause sleepiness or dizziness, temazepam may make your
    sleepiness or dizziness much worse.

    The most common side effects of temazepam include:
    • drowsiness
    • headache
    • tiredness
    • nervousness
    • dizziness
    • nausea
    You may still feel drowsy the next day after taking temazepam. Do not
    drive or do other dangerous activities after taking temazepam until
    you feel fully awake.

    These are not all the possible side effects of temazepam. Call your doctor
    for medical advice about side effects. You may report side effects to FDA at
    1-800-FDA-1088.

    How should I store temazepam?
    • Store temazepam at room temperature between 68°F to 77°F (20°C to
    25°C).
    • Keep temazepam and all medicines out of the reach of children.


    General information about the safe and effective use of temazepam.
    Medicines are sometimes prescribed for purposes other than those listed
    in a Medication Guide. Do not use temazepam for a condition for which it
    was not prescribed. Do not give temazepam to other people, even if they
    have the same symptoms that you have. It may harm them. You can ask
    your healthcare provider or pharmacist for information about temazepam
    that is written for healthcare professionals.

    What are the ingredients in temazepam?


    7.5mg Capsules
    Active Ingredient: temazepam USP


    7.5 mg Capsules
    Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate,
    sodium lauryl sulfate, FD&C Red #40 and titanium dioxide.


    May also include: sodium lauryl sulfate. Imprinting ink may contain
    ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac,
    potassium hydroxide, propylene glycol, and black iron oxide.

    If you would like more information, call McKesson Corporation dba SKY
    Packaging at 1-888-243-4363


    This Medication Guide has been approved by the U.S. Food and Drug
    Administration

    Medication guides available from 1-888-243-4363


    Manufactured by:
    Novel Laboratories, Inc
    Somerset, NJ 08873


    Distributed by:
    McKesson Corporation dba SKY Packaging
    Memphis, TN 38141


    Rev. July 2024


    21359-2

  • HOW SUPPLIED

    Temazepam Capsules USP


    7.5 mg


    Pink opaque cap and white opaque body, imprinted “7.5 mg” on cap and “Novel 120” on the body in black ink.
    Box of 3 x 10 UD 30 NDC 63739-003-33


    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].

    Medication guides available from 1-888-243-4363

    Manufactured by:
    Novel Laboratories, Inc.
    Somerset, NJ 08873

    Distributed by:

    McKesson Corporation dba SKY Packaging

    Memphis, TN 38133

    Toll Free 1-888-243-4363

    Rev. July 2024

    21359-2

  • BOXED WARNING (What is this?)

    BOXED WARNING

    WARNING: 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.


    • 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 Restoril 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).

  • temazepam

    temazepam

  • INGREDIENTS AND APPEARANCE
    TEMAZEPAM 
    temazepam capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63739-003(NDC:67877-148)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS) TEMAZEPAM7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    AMMONIA (UNII: 5138Q19F1X)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    SHELLAC (UNII: 46N107B71O)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    Colorwhite (white opaque body) , pink (pink opaque cap) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 7;5mg;Novel120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63739-003-333 in 1 BOX, UNIT-DOSE11/04/2015
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07145706/28/2012
    Labeler - McKesson Corporation dba SKY Packaging (140529962)
    Establishment
    NameAddressID/FEIBusiness Operations
    Legacy Pharmaceutical Packaging, LLC143213275repack(63739-003)