Temazepam has been used in military and civilian aircrew for the short-term treatment of insomnia associated with circadian rhythm disturbance for many years. Specific treatment should be directed towards other underlying causes of insomnia such as adjustment disorder. Temazepam is short acting and hangover effects are uncommon. However, drowsiness or light-headedness the next day, confusion, ataxia and amnesia are possible side-effects so the medication should be started for the first time when it is certain licence privileges will not be exercised the following day. Thereafter, it should be taken no less than eight hours before exercising licence privileges. Aircrew should not take temazepam continuously for more than one week because of the risk of dependency developing.
Zaleplon is also acceptable for EASA medical certification subject to the same considerations as Temazepam.
All other hypnotics, including zolpidem, zopiclone and “over the counter” preparations such as diphenhydramine and promethazine are disqualifying for EASA medical certification.
Melatonin is a hormone produced nocturnally by the pineal gland. It serves as a circadian time cue promoting sleep. With age, melatonin production declines and the prevalence of sleep disorders, particularly insomnia, increases. Prolonged release melatonin has shown good results in treating insomnia in older adults and the European Medicines Agency has approved Circadin 2 mg (prolonged-release melatonin) for patients aged 55 or over for the short-term treatment of primary insomnia. However, there is no evidence that melatonin is effective in treating secondary sleep disorders or sleep disorders accompanying sleep restriction, such as jet lag. Melatonin preparations are not always pure pineal extract and may contain herbs such as valerian and chamomile, together with amino acids, calcium and magnesium. It is not acceptable for EASA medical certification.
Modafinil is a central nervous system stimulant prescribed for narcolepsy and daytime sleepiness due to obstructive sleep apnoea. Common side-effects (>1:100) include anxiety, depression, dizziness and impaired concentration. Both obstructive sleep apnoea associated with significant daytime drowsiness despite CPAP treatment and narcolepsy are disqualifying and so any applicant taking this medication is unfit for flying duties.
Smoking cessation medication
Nicotine replacement therapy is acceptable.
Varenicline is a selective nicotine receptor partial agonist used for smoking cessation. Common side effects include drowsiness, dizziness and sleep disorder. Less commonly (1:1000 – 1:100) it can cause atrial fibrillation, palpitations, panic attacks, mood swings, incoordination, visual disturbance, myocardial infarction, anxiety, depression, irrational behaviour, psychosis and suicidal ideation. Varenicline is not compatible with aeromedical certification.
Bupropion is used for smoking cessation though its mode of action is unknown. Common side effects include anxiety, depression, dizziness and impaired concentration. Less commonly it can cause confusion and visual disturbance. Applicants are ‘unfit whilst taking this medication.
The SSRIs sertraline, citalopram and escitalopram are the only antidepressants permitted for EASA medical certification – see the Depression flow chart. Citalopram and escitalopram are associated with dose-dependent QT interval prolongation and should not be used in those with congenital long QT syndrome, known pre-existing QT interval prolongation or in combination with other medicines that prolong the QT interval. ECG measurements should be considered and electrolyte disturbances should be corrected before starting treatment. For citalopram, the maximum daily doses are: 40 mg for adults and 20 mg for patients older than 65 years. For escitalopram, the maximum daily doses are: 20 mg for adults and 10 mg for patients older than 65 years.
St John’s Wort can be purchased without prescription and is used for the treatment of depression though it is not licensed for this purpose. It interacts with other medicines and the quality and quantity of active ingredient in the various preparations available is variable. An applicant or certificate holder on this treatment should be assessed as unfit and follow the Depression flow chart.
The SNRI duloxetine is not permitted as an antidepressant but is non-sedating and medical certification may be considered for those applicants using a lower dosage for neuropathic pain.
The half-life of amitriptyline is 18 to 24 hours and active metabolites have a longer half-life. Sedation occurs at all dose levels. It is not compatible with EASA medical certification even at the low doses used for treating neuropathic pain.
Epilepsy is disqualifying so these drugs are incompatible with EASA medical certification. Gabapentin and carbamazepine prescribed for neuropathic pain and valproate for migraine prophylaxis are disqualifying for EASA medical certification because of the risk of unacceptable side effects.
Antipsychotic drugs are not usually compatible with EASA medical certification because the condition for which they are prescribed is likely to be disqualifying. However, low dose sulpiride (less than 400mg daily) is acceptable for the treatment of Tourette’s syndrome (unlicensed indication) provided a clinical report confirms treatment is successful without significant side-effects and a medical flight test gives a satisfactory result. The use of clonazepam for treating tics is disqualifying.