Temazepam

Restoril is labeled for short-term insomnia, generally 7–10 days, in adults; it can address difficulty initiating sleep and frequent nighttime awakening. It is a prescription Schedule IV controlled substance marketed under NDA018163. Trials supporting the label lasted 2 weeks; that is not an approval of indefinite therapy or evidence of established long-term safety.

Evaluate physical/psychiatric causes before treating symptoms. If insomnia does not improve after 7–10 days, or new behavior/thinking changes develop, reassess rather than automatically raise the dose or renew nightly treatment. This reference does not supply a pediatric, anxiety or seizure regimen. A full current insomnia guideline was not available for review, so no guideline-specific treatment ranking is asserted.

The usual dose is 15 mg before retiring. Some adults need only 7.5 mg; selected patients may require 30 mg. For transient insomnia, 7.5 mg may improve sleep latency. Take only the prescribed bedtime dose, immediately before getting into bed, when a full night’s sleep is possible. The 30 mg higher label dose is not a target for every patient. No middle-of-the-night supplemental or repeat-dose regimen is supplied.

Start older/debilitated patients at 7.5 mg because larger doses increase oversedation, confusion, dizziness and ataxia. Renal/hepatic impairment and chronic pulmonary insufficiency require caution, but this label does not supply a numerical CrCl/eGFR-based, hepatic-category or dialysis adjustment. If an opioid is already used, initial temazepam should be lower than otherwise indicated and individualized; the label does not define a universal co-prescribing mg dose.

Prescribe a short course, usually 7–10 days. Continued use can cause dependence; discontinuation/reduction requires an individualized gradual taper. If withdrawal occurs, the clinician may pause the taper or return to the preceding taper level, then decrease more slowly. Do not invent a fixed percentage taper for every patient or confuse dependence with addiction.

The current Medication Guide says not to take Restoril with allergy to temazepam or its ingredients; patients with treatment-associated angioedema must not be rechallenged. The retained full prescribing information has no separate CONTRAINDICATIONS section despite a dangling reference to one. No removed historical pregnancy contraindication is imported: current pregnancy counseling addresses fetal/neonatal risks and individualized review. This labeling gap is documented in the audit.

The current label has a boxed warning covering opioid co-use, abuse/misuse/addiction, and physical dependence/withdrawal. Respiratory depression can be fatal, and abrupt withdrawal can be life-threatening. Complex sleep behaviors are discussed in warnings; do not confuse their placement with the boxed-warning scope.

Common labeled trial effects include drowsiness, headache, fatigue, nervousness, dizziness and nausea. Residual next-day sedation, confusion, impaired coordination and amnesia can occur; individual safety cannot be inferred from the label’s older efficacy-trial claim of minimal hangover. Rare serious allergic or paradoxical behavioral reactions require urgent assessment. Depression/suicidal thinking and falls need particular attention.

Opioids act at different respiratory-control receptors and can markedly worsen benzodiazepine respiratory depression. Alcohol, sedative antihistamines, other hypnotics/anxiolytics, antipsychotics, antidepressants, anticonvulsants and anesthetics may add CNS depression. Reconcile prescription/OTC medicines and planned anesthesia; do not independently combine sleep aids.

The label reports no apparent PK change with cimetidine used according to its labeling; that is not proof of no interaction with every inhibitor. Diphenhydramine can have additive/synergistic effects; the label’s isolated pregnancy case report does not establish causality. Flumazenil can precipitate seizures/withdrawal, especially with chronic dependence or mixed overdose; reversal requires emergency clinical judgment and airway/supportive care.

Pediatric safety/effectiveness are not established. Older adults require an initial 7.5 mg dose and close assessment because sedation, confusion, ataxia and falls increase with dose; the trials had limited older-patient representation. Age alone does not remove the need to assess other sedatives, organ function and respiratory disease.

Use caution in kidney/liver impairment and chronic pulmonary insufficiency; the selected label supplies no validated organ-specific numerical schedule. Severe or latent depression requires protective assessment for suicidal tendencies; new behavioral symptoms warrant immediate evaluation. Conjugation-based metabolism does not make severe liver disease or combined sedative exposure automatically safe.

Current observational benzodiazepine data do not show a clear major-birth-defect association, but this does not establish absence of risk. Late-pregnancy exposure can cause neonatal respiratory depression, hypotonia, poor feeding and withdrawal; monitor exposed newborns accordingly. Discuss pregnancy plans/exposure promptly and consider the pregnancy registry. Do not abruptly stop dependent therapy without a clinician-managed plan.

Current labeling acknowledges milk transfer and advises monitoring for infant sedation, poor feeding and poor weight gain; milk-production effects are unknown. LactMed reports generally low milk exposure and small reassuring studies, while recommending the same infant monitoring. These limited observations do not establish safety for every dose, preterm infant or sedative combination. Individualize treatment and feeding with the clinical team.

Benzodiazepines interact at GABAA sites and depress CNS activity. The hypnotic effect can improve sleep initiation/maintenance but also impair memory, coordination and consciousness. Tolerance may develop during continued use, while little tolerance develops to some amnestic/cognitive effects; apparent tolerance is not a reason for unsupervised escalation.

Temazepam is well absorbed with minimal first-pass metabolism; plasma protein binding is about 96%. In label studies, terminal half-life ranged 3.5–18.4 hours, mean 8.8 hours. Conjugation produces inactive metabolites, with 80–90% of a dose recovered in urine. A studied 30 mg capsule reached peak levels around 1.5 hours; that is not a guarantee of immediate sleep or no next-day impairment.

The reviewed 7.5/15/22.5/30 mg products are oral capsules. No injectable, oral-liquid or ER conversion is supplied. Study-specific PK and older sleep-laboratory results do not establish equal risk in frail patients, renal/hepatic disease, opioid combinations or sleep-disordered breathing; apply the labeled clinical precautions.

Before prescribing, evaluate insomnia causes, psychiatric/substance-use history, sedating medicines, pulmonary disease and organ function. Follow sleep response, next-day alertness, falls, breathing changes, complex behaviors and misuse/dependence. Reassess unresolved insomnia after 7–10 days. The label reports possible benzodiazepine blood-count/liver-test abnormalities but does not mandate one universal lab schedule for every brief course.

Take immediately before bed only with a full night available, and never exceed the prescription. Avoid alcohol and unapproved sedating combinations; do not drive or perform hazardous tasks until fully awake and the response is known. Read the Medication Guide. Do not share; secure the controlled medicine away from children/others and discuss disposal of unused capsules.

Get emergency care for slowed/stopped breathing, inability to awaken, severe allergic swelling, seizures or overdose. Contact the clinician immediately after sleep-driving or alarming behavioral changes. Do not abruptly stop or rapidly reduce continued use; withdrawal management and any flumazenil decision require a clinical plan. The printed overdose telephone number has a source error and is not reproduced here.

Selected Restoril 15 mg capsules have a maroon cap marked RESTORIL 15 mg in white and a pink body marked FOR SLEEP/registered symbol in red. A100-capsule bottle is NDC 0406-9916-01. SpecGx is the label packager/manufacturer-for entity; current package panels display Par Health. Other strengths/generics have different appearances and NDCs.

The reviewed oral capsule strengths are 7.5, 15, 22.5 and 30 mg temazepam. They contain lactose, gelatin and formulation-dependent dyes/other excipients; verify the exact dispensed product for allergy concerns. No claim is made that the 22.5 mg capsule is a standard starting dose or that other dosage forms are interchangeable.

Store 20–25°C in a well-closed, light-resistant container with child-resistant closure. Keep secure and out of children’s reach. Dispense/read the Medication Guide; retain the original label to verify strength and directions. Follow the actual pharmacy/product instructions for disposal.