Suggested Dosing
Benzodiazepine Withdrawal in Elderly with Insomnia
2 mg controlled-release PO qHS for up to 6 months; taper dose over 6 weeks
Cancer, Adjunctive Therapy
10-50 mg PO daily
Cluster Headache, Prevention
10 mg PO qHS
Migraine Headache
3 mg PO HS
Insomnia
3-5 mg PO qHS
Difficulty falling asleep
- 5 mg PO 3-4 hour before sleep period x 4 weeks
Difficulty maintaining sleep
- Use controlled release formulation
Thrombocytopenia, Chemo-related
20 mg PO qHS
Jet Lag
0.5-5 mg PO HS
Eastbound
- Preflight, early evening dose followed by HS dosing x 4days
Westbound
- Treat HS x 4days when in new time zone
Chronic Fatique Syndrome
5 mg PO HS
Nicotine Withdrawal
0.3 mg PO 3.5 hours after stopping smoking
Winter Depression
0.125 mg PO twice daily
Premedication for Surgery
0.5 mg/kg SL
Tardive Dyskinesia
10 mg controlled-release PO qDay
Orphan Designations
Sleep disorders
- Orphan designation for treatment of circadian rhythm sleep disorders in blind people without light perception
- Sponsors
- Neurim Pharmaceuticals, Ltd; 8 Hanechoshet St; Tel-Aviv, Israel
- Sack, Robert, M.D.; Oregon Health Sciences University, 3181 S.W. Sam Jackson Park Road; Portland, OR 97201
Encephalopathy
- Orphan designation for treatment of neonatal hypoxic ischemic encephalopathy
- Sponsor: Scharper S.p.A.; Viale Ortles 12; Milan 20139, Italy
Smith-Magenis syndrome
- Orphan designation for treatment of Smith-Magenis syndrome in combination with a beta-blocker
- Sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy
Acetaminophen overdose
- Orphan designation for treatment of acute acetaminophen overdose
- Sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy
Short bowel syndrome
- Orphan designation for treatment of short bowel syndrome
- Sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy
Necrotizing enterocolitis
- Orphan designation for treatment of necrotizing enterocolitis
- Sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy
Suggested Uses
Alzheimer's disease, benzodiazepine or nicotine withdrawal, cancer (adjunctive treatment), headache (prevention), insomnia, jet lag, shift-work disorder, sleep disorders , thrombocytopenia (chemo-induced), winter depression, tardive dyskinesia
Efficacy
Circadian rhythm sleep disorders: FDA orphan drug status
Insomnia: Helpful for sleep-wake cycle disorders
Research is continuing
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
Abdominal cramps
Alertness decreased
Circadian rhythm disruption
Daytime fatigue
Depression (transient)
Dizziness
Drowsiness
Dysphoria in depressed patients
Headache
Irritability
Warnings
Contraindications
Concurrent immunosuppressive treatment
Cautions
Age <20 years old, depression, hypertension, impaired liver function, seizure disorder
Pregnancy & Lactation
Pregnancy Category: avoid use
Lactation: avoid use
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Hormone produced by pineal gland; regulates sleep cycle
Pharmacokinetics
Not studied
