Temazepam
Capsule · Oral
Uses
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 USP 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.
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 ).
Warnings
Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use 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 capsules 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 capsules 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 capsules, 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 capsules are 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 capsules, 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 capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of temazepam capsules, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of temazepam capsules 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 capsules 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 Capsules ). 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 capsules, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of temazepam capsules 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 capsules, 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 capsules alone at therapeutic doses, the use of alcohol and other CNS depressants with temazepam capsules appear to increase the risk of such behaviors, as does the use of temazepam capsules at doses exceeding the maximum recommended dose.
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 capsules are recommended as the initial dosage for such patients. Temazepam capsules 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 capsules are 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 capsules and diphenhydramine. One case of stillbirth at term has been reported 8 hours after a pregnant patient received temazepam capsules 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 capsules are 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 capsules, 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 capsules may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of temazepam capsules 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 capsules 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 capsules are 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 capsules 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 capsules 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 capsules 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.
Side effects
During controlled clinical studies in which 1076 patients received temazepam capsules 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 Capsules % 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 interactions
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.
Pregnancy
Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including temazepam capsules, 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 capsules during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to temazepam capsules 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.
Pediatric use
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric use
Geriatric Use Clinical studies of Restoril 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 capsules 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.
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 (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.
Description
Temazepam Capsules USP are benzodiazepine hypnotic agents. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2 H -1,4-benzodiazepin-2-one, and the structural formula is: Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. Chemical Structure 7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules Active Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, iron oxide red, shellac, shellac glaze, SD-35A alcohol. 15 mg Capsules Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol. 22.5 mg Capsules Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol. 30 mg Capsules Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.
How supplied
Temazepam Capsules USP 7.5 mg Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and on the other side in red, and a blue cap imprinted “7.5 mg” twice in red. Bottle of 100 . . . . . . . . .NDC 0406-9960-01 Boxed M 15 mg Maroon and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and on the other side in red, and a maroon cap imprinted “15 mg” twice in white. Bottle of 100. . . . . . . . .NDC 0406-9961-01 Boxed M 22.5 mg Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and on the other side in red, and an opaque blue cap imprinted “22.5 mg” twice in red. Bottle of 30 . . . . . . . . . .NDC 0406-9959-03 Boxed M 30 mg Maroon and blue capsules, with the blue body imprinted “FOR SLEEP” on one side and on the other side in red, and a maroon cap imprinted “30 mg” twice in white. Bottle of 100. . . . . . . . .NDC 0406-9962-01 Boxed M 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]. © 2026 Par Health, Inc. or one of its affiliates. Product of Italy Manufactured for: SpecGx LLC Webster Groves, MO 63119 Rev 03/2026 Par Health™
Patient information
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 capsules are 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 capsules, 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 capsules may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of temazepam capsules 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 capsules 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 capsules are 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 capsules 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 capsules 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 capsules 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 ).
Label text from the FDA structured product label by SpecGx LLC (revised Jun 4, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Temazepam in 84 products
Temazepam NDC products (84)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0285 | Temazepam 30 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-0186 | Temazepam 15 mg/1 Capsule | A-S Medication Solutions | ANDA · DEA CIV |
| 0228-2077 | Temazepam 30 mg/1 Capsule | Actavis Pharma, Inc. | ANDA · DEA CIV |
| 0228-2076 | Temazepam 15 mg/1 Capsule | Actavis Pharma, Inc. | ANDA · DEA CIV |
| 80425-0295 | Temazepam 30 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0191 | Temazepam 15 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 62332-379 | Temazepam 7.5 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CIV |
| 62332-382 | Temazepam 30 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CIV |
| 62332-381 | Temazepam 22.5 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CIV |
| 62332-380 | Temazepam 15 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA · DEA CIV |
| 46708-379 | Temazepam 7.5 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CIV |
| 46708-380 | Temazepam 15 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CIV |
| 46708-381 | Temazepam 22.5 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CIV |
| 46708-382 | Temazepam 30 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA · DEA CIV |
| 65162-584 | Temazepam 22.5 mg/1 Capsule | Amneal Pharmaceuticals LLC | ANDA · DEA CIV |
| 65162-583 | Temazepam 7.5 mg/1 Capsule | Amneal Pharmaceuticals LLC | ANDA · DEA CIV |
| 65162-557 | Temazepam 30 mg/1 Capsule | Amneal Pharmaceuticals LLC | ANDA · DEA CIV |
| 65162-556 | Temazepam 15 mg/1 Capsule | Amneal Pharmaceuticals LLC | ANDA · DEA CIV |
| 53746-556 | Temazepam 15 mg/1 Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CIV |
| 53746-557 | Temazepam 30 mg/1 Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CIV |
| 67544-136 | Temazepam 15 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-986 | Temazepam 30 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 43353-260 | Temazepam 30 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 43353-312 | Temazepam 15 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 67877-146 | Temazepam 15 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CIV |
| 67877-147 | Temazepam 30 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CIV |
| 67877-148 | Temazepam 7.5 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CIV |
| 67877-149 | Temazepam 22.5 mg/1 Capsule | Ascend Laboratories, LLC | ANDA · DEA CIV |
| 76420-475 | Temazepam 30 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-474 | Temazepam 22.5 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-472 | Temazepam 7.5 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-473 | Temazepam 15 mg/1 Capsule | Asclemed USA, Inc. | ANDA · DEA CIV |
| 50268-780 | Temazepam 30 mg/1 Capsule | AvPAK | ANDA · DEA CIV |
| 50268-779 | Temazepam 15 mg/1 Capsule | AvPAK | ANDA · DEA CIV |
| 71335-2965 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0315 | Temazepam 15 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-1901 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2043 | Temazepam 22.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2302 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2900 | Temazepam 15 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2910 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 72162-1826 | Temazepam 7.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-9741 | Temazepam 15 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 72162-1827 | Temazepam 22.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 72162-1824 | Temazepam 15 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 72162-1825 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-1057 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-8606 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-1619 | Temazepam 15 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-1621 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-8601 | Temazepam 7.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-8602 | Temazepam 15 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-8603 | Temazepam 15 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-8604 | Temazepam 22.5 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-8605 | Temazepam 30 mg/1 Capsule | Bryant Ranch Prepack | ANDA · DEA CIV |
| 51407-507 | Temazepam 15 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 51407-508 | Temazepam 30 mg/1 Capsule | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 0904-6436 | Temazepam 7.5 mg/1 Capsule | Major Pharmaceuticals | ANDA · DEA CIV |
| 66267-321 | Temazepam 30 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-4083 | Temazepam 30 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 55289-660 | Temazepam 30 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 55289-196 | Temazepam 15 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68788-8493 | Temazepam 15 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-8139 | Temazepam 15 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-8081 | Temazepam 30 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 71205-915 | Temazepam 30 mg/1 Capsule | Proficient Rx LP | ANDA · DEA CIV |
| 71205-914 | Temazepam 15 mg/1 Capsule | Proficient Rx LP | ANDA · DEA CIV |
| 63187-497 | Temazepam 30 mg/1 Capsule | Proficient Rx LP | ANDA · DEA CIV |
| 63187-132 | Temazepam 15 mg/1 Capsule | Proficient Rx LP | ANDA · DEA CIV |
| 70518-2487 | Temazepam 15 mg/1 Capsule | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-0647 | Temazepam 15 mg/1 Capsule | REMEDYREPACK INC. | ANDA · DEA CIV |
| 43547-611 | Temazepam 7.5 mg/1 Capsule | Solco Healthcare U.S., LLC | ANDA · DEA CIV |
| 43547-614 | Temazepam 30 mg/1 Capsule | Solco Healthcare U.S., LLC | ANDA · DEA CIV |
| 43547-613 | Temazepam 22.5 mg/1 Capsule | Solco Healthcare U.S., LLC | ANDA · DEA CIV |
| 43547-612 | Temazepam 15 mg/1 Capsule | Solco Healthcare U.S., LLC | ANDA · DEA CIV |
| 68084-549 | Temazepam 7.5 mg/1 Capsule | American Health Packaging | NDA · DEA CIV |
| 71610-626 | Temazepam 30 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | NDA · DEA CIV |
| 71610-625 | Temazepam 15 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | NDA · DEA CIV |
| 71610-004 | Temazepam 7.5 mg/1 Capsule | Aphena Pharma Solutions - Tennessee, LLC | NDA · DEA CIV |
| 72789-449 | Temazepam 30 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | NDA · DEA CIV |
| 0406-9962 | Temazepam 30 mg/1 Capsule | SpecGx LLC | NDA · DEA CIV |
| 0406-9961 | Temazepam 15 mg/1 Capsule | SpecGx LLC | NDA · DEA CIV |
| 0406-9960 | Temazepam 7.5 mg/1 Capsule | SpecGx LLC | NDA · DEA CIV |
| 0406-9959 | Temazepam 22.5 mg/1 Capsule | SpecGx LLC | NDA · DEA CIV |
Frequently asked questions
What is Temazepam used for?
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 USP 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…
What are the side effects of Temazepam?
During controlled clinical studies in which 1076 patients received temazepam capsules 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 Capsules % Incidence (n=1076) Placebo % Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness… See the full label for the complete list.
Who makes Temazepam?
Temazepam is listed by 22 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Advanced Rx Pharmacy of Tennessee, LLC, Alembic Pharmaceuticals Inc..