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RESTORIL (TEMAZEPAM)
- Insomnia
15 mg capsule
- 1 capsule (15 mg) by oral route once daily at bedtime as needed
22.5 mg capsule
- 1 capsule (22.5 mg) by oral route once daily at bedtime
30 mg capsule
- 1 capsule (30 mg) by oral route once daily at bedtime as needed
7.5 mg capsule
- 1 capsule (7.5 mg) by oral route once daily at bedtime as needed
15 mg capsule
- 1 capsule (15 mg) by oral route once daily at bedtime as needed
22.5 mg capsule
- 1 capsule (22.5 mg) by oral route once daily at bedtime
30 mg capsule
- 1 capsule (30 mg) by oral route once daily at bedtime as needed
7.5 mg capsule
- 1 capsule (7.5 mg) by oral route once daily at bedtime as needed
15 mg capsule
- 1 capsule (15 mg) by oral route once daily at bedtime as needed
22.5 mg capsule
- 1 capsule (22.5 mg) by oral route once daily at bedtime
30 mg capsule
- 1 capsule (30 mg) by oral route once daily at bedtime as needed
7.5 mg capsule
- 1 capsule (7.5 mg) by oral route once daily at bedtime as needed
Insomnia
- 1 capsule (15 mg) by oral route once daily at bedtime as needed
- 2 capsules (15 mg) by oral route once daily at bedtime as needed
- 2 capsules (30 mg) by oral route once daily at bedtime as needed
- 1 capsule (30 mg) by oral route once daily at bedtime as needed
- 1 capsule (22.5 mg) by oral route once daily at bedtime
- 1 capsule (7.5 mg) by oral route once daily at bedtime as needed
- sodium oxybate
- Xyrem
Contraindicated
- clozapine
- Clozaril
- Dehydrated Alcohol
- ethanol (ethyl alcohol)
- ethyl alcohol-herbal drugs
- Fazaclo
- Lydia Pinkham Herbal
- Versacloz
Severe
Moderate
- buprenorphine-naloxone
- Suboxone
- Zubsolv
- Pregnancy
Contraindicated
- Alcohol intoxication
- Complex sleep behavior
- Depression
- Drug abuse
- Memory impairment
- Severe chronic obstructive pulmonary disease
- Sleep apnea
Severe
Moderate
- Chronic pulmonary disease
- Disease of liver
- Hypoalbuminemia
- Suicidal ideation
RESTORIL (TEMAZEPAM)
- Insomnia
- Muscle weakness
- Ataxia
- Dizziness
- Drowsy
- Dyspepsia
- Slurred speech
More Frequent
Severe
Less Severe
- Acute confusion
- Behavioral disorders
- CNS depression
- Diarrhea
- Fatigue
- General weakness
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Accidental fall
- Agranulocytosis
- Anaphylaxis
- Anemia
- Angioedema
- Aplastic anemia
- Apnea
- Coma
- Dehydration
- Depression
- Disease of liver
- Drug-induced psychosis
- Eosinophilia
- Hallucinations
- Hemolytic anemia
- Hepatomegaly
- Hostility
- Hypotension
- Jaundice
- Leukocytosis
- Leukopenia
- Manic disorder
- Memory impairment
- Neutropenic disorder
- Respiratory depression
- Seizure disorder
- Skin rash
- Sleep walking disorder
- Suicidal ideation
- Thrombocytopenic disorder
- Urinary retention
Less Severe
- Aggressive behavior
- Agitation
- Alopecia
- Anorexia
- Aphonia
- Blurred vision
- Bronchial congestion
- Complex sleep behavior
- Concentration difficulty
- Conjunctivitis
- Constipation
- Contact dermatitis
- Cramps
- Delirium
- Depersonalization
- Diplopia
- Disturbance in thinking
- Dream disorder
- Drug dependence
- Dry eye
- Dry skin
- Dysarthria
- Dyspnea
- Dysuria
- Excitement
- Eyes vertical deviation
- Facial edema
- Gastritis
- Gingival pain
- Glossitis
- Headache disorder
- Hiccups
- Hirsutism
- Increased appetite
- Irritability
- Libido changes
- Loss of taste
- Lymphadenopathy
- Menstrual disorder
- Myalgias
- Nausea
- Nervousness
- Nightmares
- Nocturia
- Nystagmus
- Orthostatic hypotension
- Palpitations
- Paranoid disorder
- Polydipsia
- Pruritus of skin
- Rhinorrhea
- Sialorrhea
- Sleep disorder
- Sneezing
- Sore tongue
- Stomatitis
- Swelling of ankles or feet
- Syncope
- Tachycardia
- Tremor
- Urinary incontinence
- Urine discoloration
- Vertigo
- Visual changes
- Visual field defect
- Vomiting
- Weight gain
- Weight loss
- Xerostomia
- Yawning
Contraindicated
None
Severe Precaution
Temazepam
Increased CNS effects in pediatrics (prolonged in neonates).
- 1 Day – 18 Years
- Increased CNS effects in pediatrics (prolonged in neonates).
Management or Monitoring Precaution
None
Temazepam
- Severity Level:
X
- Additional Notes:
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Temazepam
Insufficient data available; monitor infant for adverse effects
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Insufficient data available; monitor infant for adverse effects |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Temazepam
Neuro/Psych-Increased risk of cognitive impairment, delirium, falls, fractures, and motor vehicle crashes. General-Shorter-acting benzodiazepines are not safer than longer-acting ones. If used, limit duration and initial dose to 7.5 mg/day and max dose to 15 mg/day.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | Y | N | N |
BEERS: Y HEDIS: Y STOPP: Y
No Known Risk
None
- Taking temazepam with opioid medications (such as codeine, hydrocodone) may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of temazepam that works, and take it for the shortest possible time. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
| Insomnia | |
| F51.0 | Insomnia not due to a substance or known physiological condition |
| F51.01 | Primary insomnia |
| F51.02 | Adjustment insomnia |
| F51.03 | Paradoxical insomnia |
| F51.04 | Psychophysiologic insomnia |
| F51.05 | Insomnia due to other mental disorder |
| F51.09 | Other insomnia not due to a substance or known physiological condition |
| G47.0 | Insomnia |
| G47.00 | Insomnia, unspecified |
| G47.01 | Insomnia due to medical condition |
| G47.09 | Other insomnia |
| 0-9 | A-Z |
|---|---|
| F51.0 | Insomnia not due to a substance or known physiological condition |
| F51.01 | Primary insomnia |
| F51.02 | Adjustment insomnia |
| F51.03 | Paradoxical insomnia |
| F51.04 | Psychophysiologic insomnia |
| F51.05 | Insomnia due to other mental disorder |
| F51.09 | Other insomnia not due to a substance or known physiological condition |
| G47.0 | Insomnia |
| G47.00 | Insomnia, unspecified |
| G47.01 | Insomnia due to medical condition |
| G47.09 | Other insomnia |
Formulary Reference Tool