s, 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 drug interactions ). 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 sedativehypnotic-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 appears to increase the risk of such behaviors, as does the use of temazepam capsules at doses exceeding the maximum recommended dose. due to the risk to the patient and the community, discontinuation of temazepam capsules 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. withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines ( see drug abuse and dependence ). 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 capsules. 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 capsules should not be rechallenged with the drug.

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 ).

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

ntration/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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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.

ules ndc 46708-382-90 bottle of 90 capsules ndc 46708-382-31 bottle of 100 capsules ndc 46708-382-71 bottle of 500 capsules dispense in a well-closed, light-resistant container with a child-resistant closure. storage: store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. the brands listed are trademarks of their respective owners. manufactured by: alembic pharmaceuticals limited (formulation division), village panelav, p. o. tajpura, near baska, taluka-halol, panchmahal, gujarat, india. revised: 09/2018

€œsleep-driving”, patients usually do not remember these events.