Flunitrazepam
Indications
Registered South African indications:
- Insomnia
Boxed warning
| Use of flunitrazepam (even at therapeutic doses) may lead to the following: - Dependence: Use of flunitrazepam may lead to the development of physical and psychological dependence on these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. Abuse has been reported. - Amnesia: Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour. Interactions: Flunitrazepam should be avoided in patients with a history of alcohol or drug abuse. In the case of narcotic analgesics, enhancement of the euphoria may also occur, leading to an increase in psychological dependence. |
Cautions
Contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- Hypersensitivity to benzodiazepines
- Pregnancy
- Breastfeeding
- Severe hepatic impairment
- Severe chronic hypercapnia
- Myasthenia gravis
- Severe respiratory insufficiency
- Sleep apnoea syndrome
- Children
- Coadministration with alcohol
Cautions
- Renal impairment
- Mild to moderate hepatic impairment
- Elderly
- Porphyria
- History of alcohol or drug abuse
- Abrupt withdrawal
- Psychotic illness
- Prolonged use
- Chronic respiratory insufficiency
- Lapp lactase deficiency
- Galactose intolerance
- Glucose-galactose malabsorption
- May impair ability to drive and operate machinery
Adult dosage
Forms avail. in SA and covered in this monograph: tab
Short term insomnia
- Oral (tab): 0.5-1mg, dly, just before retiring; Max. treatment duration: 4 weeks
Taper off slowly to discontinue
Paediatric dosage
Not established for use in children
Special populations
Pregnancy
- Contraindicated
- Data is insufficient to assess the safety of flunitrazepam during pregnancy
- Flunitrazepam crosses the placenta. Infants born to mothers who chronically took benzodiazepines during the late stages of pregnancy are at risk of developing withdrawal symptoms and may develop physical dependence
- When flunitrazepam is given during labour, floppy infant syndrome may occur, which is characterized by poor sucking, hypothermia and central respiratory depression
Breastfeeding
- Contraindicated
- Flunitrazepam crosses the human placenta after a single dose
Renal Impairment
Hepatic Impairment
- Mild to moderate: Caution; dose adjustment recommended
A reduced dose should be given to patients with impaired liver function - Severe: Contraindicated
Elderly
- Caution; no dose adjustment recommended
The recommended dose is 0.5mg dly
Porphyria Information
Drugs in Sport
- Permitted - No warning
Adverse reactions
Central Nervous System Disorders
- Headache
- Dizziness
- Ataxia
- Anterograde amnesia
- Drowsiness
- Numbed emotions
- Reduced alertness
- Confusion
- Libido disorder
- Restlessness
- Agitation
- Irritability
- Aggressiveness
- Delusion
- Rages
- Nightmares
- Hallucinations
- Psychoses
- Inappropriate behaviour
- Adverse behavioural effects
- Physical dependence
- Withdrawal or rebound phenomena
- Psychological dependence
- Unmasking or pre-existing depression
- Fatigue
Gastrointestinal Disorders
- Gastrointestinal disturbances
Musculoskeletal Disorders
- Muscular weakness
- Increased risk for falls and fractures
Skin and Subcutaneous Tissue Disorders
- Skin reactions
Immune, Blood and Lymphatic System Disorders
- Hypersensitivity reactions
- Angioedema
Sensory Disorders
- Double vision
Interactions
- Central nervous system depressants
- CYP450 inhibitors
Monitoring
None routine
Mechanism of action
Flunitrazepam is a full benzodiazepine agonist with a high affinity for the benzodiazepine central site. It has anxiolytic, anticonvulsant and sedative effects, and induces slowing of psychomotor performance, amnesia, muscle relaxation and sleep.
Dosage forms
- Tablet
Formulation
Tablet 1mg
- Hypnor (Sandoz)
- Rohypnol (Roche) originator
- Sandoz Flunitrazepam (Sandoz)
References
1. SAMF_12th Edition_Page 490 2. PI: Rohypnol 1mg tablets, Roche products:Date of registration: 25 Nov 2011 [https://drive.google.com/drive/folders/0B27NqM_vidrmRHFNZnptUHEwSXM] 3. NAPOS: The Drug Database for Acute Porphyria: Flunitrazepam; Accessed online 04 Feb 2019 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=N05CD03] 4. South African Institute for Drug-Free Sport: Rohypnol; Accessed online 04 Feb 2019 [http://www.drugfreesport.org.za/online-medication-check/] **No SPC available *No UTD, Drugs.com or Epocrates
Brands & products
3 products · cached snapshot- Hypnor
- Rohypnol
- Sandoz Flunitrazepam
TABTablet· 3 products
from R70.31| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Hypnor | 1 mg | 30 | Sandoz SA (Pty) Ltd | R70.31 |
| Sandoz Flunitrazepam 1discontinued | 1 mg | 30 | Sandoz SA (Pty) Ltd | R71.79 |
| Rohypnol | 1 mg | 30 | Roche Products (Pty) Ltd | R162.36 |
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.